Overview of the U.S. Biosimilar Drug Market 2020

Author: Nesta

The moss marks are green, and the grass is green, and the warm and cold early spring comes quietly in anticipation.

1.

The biosimilar group consisting of 18 351(K) approved products further accelerated its penetration in 2020 and handed in a final answer sheet of US$4.

2.

List of U.

Ruxience and other 5 biosimilar drugs were successfully launched in 2020.

List of biosimilar drugs launched in the U.

Up to now, the total number of approved biosimilar drugs declared through the 351(K) route and the number of marketed biosimilars have reached 29 and 20, respectively.

Overview of the number of approved and marketed biosimilar drugs in the United States over the years

List of the cumulative number of US biosimilar drugs approved and listed by companies

A summary of the cumulative number of approved and marketed biosimilars of various products in the United States

3.

At present, there is no biosimilar drug approved in the U.

A summary of the follow-up product pipelines planned by major biosimilar players in the U.

List of products under development (clinical stage) of major biosimilar competitors in the U.

Overview of pipeline overlapping products

Specifically, the research and development of biosimilar drugs by the leader Pfizer has temporarily come to an end.

Fourth, penetration & price

20159，SandozZarxio，351(K)，。2016-20185，，，，，，“、、、”；，，，，，。

2019，7，，，，，，，。2020，5，62，5，。

2018-2020

In terms of specific figures, as of the end of 2020, the market share of the seven biosimilar drugs on sale was all over 15%, of which three products exceeded 30%.
Among the 7 products, 3 products have more than 3 biosimilars on sale.
The filgrastim biosimilar has increased its share to 72% after more than five years of development since the launch of Zarxio, and has become the product with the largest sales share of biosimilars; bevacizumab, the first biosimilar drug, Mvasi, in 2019 Since its launch in July, it took only one and a half years to increase the share of biosimilar drugs to 40%, becoming the product with the fastest penetration rate; the two biosimilar drugs involved in infliximab were all listed as early as 2017.
However, limited by the strong resistance of the original research, after more than 3 years of development, the overall share of biosimilars has just exceeded 15%, becoming the product with the slowest penetration and the lowest sales.
From the perspective of the specific biosimilar product shares of each company, the share of the first listed biosimilar drug with 3 of the 7 products accounted for more than 35%.

The rapid development and penetration of biosimilar drugs have greatly lowered the price of bio-products and saved U.
S.
medical expenditures.
According to AAM reports, biosimilars saved US$2.
2 billion in medical expenditures in 2019.
From a specific price point of view, although the price of biosimilar drugs is limited by huge R&D costs, it cannot achieve a cliff-like decline after patent expiration like small molecule chemical drugs, but compared with the original research before the market, the price drop is not small, and more important It is the process of competition among biosimilars internally and externally with the original research product that has driven the decline in the overall market price, including the original research product.

List of price changes of products involved in biosimilar drugs

As can be seen from the above table, the latest first imitation biosimilar drug has been on the market for more than a year, and the earliest Zarxio has been on the market five and a half years ago.
Although the number of competing products and the time of entering the market of each biosimilar drug are different, they all lowered the market price to varying degrees.
Compared with the price of the original research product before the launch of biosimilar drugs, the current lowest ASP price has fallen between 24% and 63%, and the price of six products has fallen by more than 30%.
The price of filgrastim, which has the longest penetration time, has fallen the most, breaking through 60%; in recent years, the price of epoetin alfa, which has only one biosimilar drug sold in the city, has fallen the least, close to 25%.
The biosimilars corresponding to Roche's three-piece suit have only begun to enter the market in 2019, but the price reductions have exceeded 34%, and the reduction of trastuzumab has reached 43%.

V.
Litigation Progress

In October 2014, Sandoz's filgrastim biosimilar Zarxio was sued by Amgen for infringement, which officially opened the prelude to the patent litigation of biosimilar drugs under the framework of the US BPCIA Act.
Over the next six years, nearly 50 lawsuits ensued.
The original research company struggled to block, there were many new lawsuits against different patent infringements of the same product and the tug-of-war that took many years to finally separate the winners and losers.
With the continuous accumulation of their own relevant experience, the biosimilar companies also dealt with litigation.
The performance is more calm and calm, and many biological analogues have chosen to venture on the market before the lawsuit has been concluded.
With the gradual increase in competitors of biosimilar drugs, the smell of gunpowder has faded in recent years, and settlement under certain restricted conditions has gradually evolved into the main theme of the current litigation.

In terms of quantity, from 2014 to 2020 at the district court level responsible for the preliminary trial, a total of four original research drug companies, Amgen, Genetech, Janssen, and Abbvie, directed all 9 products including adalimumab, which are currently approved for biosimilars, to Celltrion.
Thirteen companies initiated 46 lawsuits, involving 28 biosimilar drugs (some of which were not approved); from the perspective of time, 2017 (11) and 2018 (12) became the most concentrated time period for litigation.
Accounted for half of the total number of lawsuits, and then began to fall.
Only 5 and 4 lawsuits were filed in 2019 and 2020 respectively.

From the perspective of company performance, Amgen plays the role of the plaintiff and the defendant, becoming the most active of the companies involved in the litigation.
As the plaintiff, it initiated 16 lawsuits and as the defendant, it undertook 8 lawsuits.
Both figures are the highest among the companies.
, Genetech ranked second for the plaintiff with 15 lawsuits, and Celltrion and Sandoz ranked second and third for the defendant with 7 and 6 cases respectively;

In terms of time consumption, Sandoz’s filgrastim biosimilar Zarxio and Celltrion’s infliximab biosimilar Inflectra took nearly five years from the initial prosecution to the final victory, becoming the biosimilar products with the longest see-saw time.
, Sandoz’s Adalimumab biosimilar drug Hyrimoz only lasted 2 months from being sued to finally reconciling with the original research, becoming the product with the shortest litigation time;

Judging from the results, among the lawsuits initiated against 28 products, 16 products eventually ended in settlements.
The biosimilar and the original research company won 5 and 2 product lawsuits respectively, and another 5 product lawsuits are still in progress.
in.

List of unresolved BPCIA lawsuits

Among the 20 biosimilar products currently on the market in the United States, 10 have chosen the risky listing before patent resolution.
Among them, Pfizer and Amgen each have 3 and 2 products, and Sandoz, Mylan, Samsung, Celltrion and Coherus each There is a product.
Among these 10 products, the lawsuits for 2 products are still in progress, 4 ended with the victory of biosimilars, and 3 have settled.
The original research only won the case for 1 of the products.
The most difficult lawsuits basically appeared in the first few years.
Bio-similar drugs are weak and when they encounter a difficult opponent like Amgen, it is not an easy task to retreat from the whole body.
With the gradual increase in the number of subsequent biosimilar drug declarations, the group has begun to form a competitive advantage.
The original researcher is unwilling to spend too much energy and money without a certain victory.
best choice.
After the old drug, the declaration and litigation of the second wave of explosive biologic drugs will become a new highlight in the next few years.
The litigation will still be concentrated on the current major players in the US market.
We will wait and see which one is strong and which is weak.

Six, policies and regulations

In recent years, at the level of policies and regulations, government agencies represented by the FDA have passed the issuance of guidelines, citizen petitions, and self-reform in multiple links such as the interchangeability of biosimilar drugs, the fairness of competition, and the timeliness of review.
The continuous and unremitting efforts of a variety of mechanisms have effectively promoted the rapid development of biosimilar drugs in the United States and laid a preliminary accumulation for further comprehensive penetration in the future.

"Teach you to do", "Listen to you"

On February 3, 2020, the FDA and FTC issued a joint statement promising that both parties will strengthen cooperation to jointly promote healthy market competition for biological products and stop anti-competitive behavior.
Specifically, the main goals of the two parties are: 1) to promote more competition in the market of original biological products and biosimilars; 2) to prevent the obstruction of obtaining samples for the development of these products; 3) to be false or misleading about these products Communicate and take appropriate measures; 4) Examine whether the patent settlement agreement violates the anti-monopoly law.
The shift from unilateral efforts to joint efforts reflects the FDA's firm determination to promote fair competition in the biological product market.

Subsequently, the FDA successively issued four guidelines concerning biosimilar drugs in one year, which regulated and clarified the guidelines in terms of publicity, review, and interchangeability.

Overview of 2020 FDA biosimilar guidelines

While actively promoting through the issuance of industry guidelines, the FDA took advantage of the biosimilar seminars co-organized with the FTC and the reauthorization of the Biosimilar User Fees Act (BsUFA III) to solicit opinions and other opportunities to actively listen to the opinions from all walks of life in the industry.
Opinions and suggestions on the development of biosimilar drugs and the interchangeability of biosimilar drugs are still the core points of the opinions of all parties.

Some opinions from all parties in the industry on the future development of biosimilar drugs

From NDA to BLA

The ten-year agreement came as scheduled.
On March 23, 2020, 96 protein products, including insulin, growth hormone, lecithin, and hyaluronidase, were converted from the previously approved chemical drug NDA to the biological drug BLA in accordance with the provisions of the BPCIA Act.
The FDA finally interpreted the term "protein" as "any alpha-amino acid polymer with a specifically defined sequence and a size greater than 40 amino acids.
" Conversion is not only a law-based approach but also a general trend.
While the definition of biological products has been further scientifically improved, it has been integrated with the European Union.
Previously, the embarrassing situation of a series of biological products represented by insulin that could not be returned was finally broken.

After the conversion, regardless of whether it was previously approved through the 505(b) or 505(b)(2) route, all NDAs will be regarded as BLA approved through the 351(a) route.
No new 351(k) biosimilars in the strict sense were born.
Nevertheless, one of the significance of the conversion is to set the tone for the subsequent registration of the same type of product and play an important role in connecting the past and the future.
The only such drug under review at the time of conversion is the insulin glargine product Semglee previously declared by Mylan as 505(b)(2).
Although its structure and even the injection device are very similar to the original product Lantus, it still has not become the only one.
Although Mylan has put a lot of effort into being able to obtain the 351(k) approval and obtain the interchangeable qualification with the original research.
Lannet and Dongyang Sunshine plan to declare insulin glargine in cooperation next year and is expected to become the first real insulin biosimilar.
In addition to the change in the identity of the product itself, the conversion also brought a series of other related changes in supervision, such as product labeling, shipping reports, and so on.
At the same time, the concept of authorized generic drugs will no longer exist, and there will be a gap that can be exploited.

Upgrade, Purple Book

The Purple Book, which is as famous as the Orange Book of Small Molecule Drugs, has played a certain role in disseminating information about approved biological products to the public since it was launched in 2014.
However, there is still a lot of information in terms of comprehensiveness and ease of use.
Great room for improvement.
In February 2020, the FDA started the 1.
0 version of the moving knife plan, and launched an online searchable online database, replacing the previous mode of browsing only through the pdf list.
The aforementioned information on each biological product converted from NDA to BLA has been changed.
Moved here after being deleted from the Orange Book.
It should be said that this move is quite worthy of affirmation.
Although a lot of information contained in the Orange Book, including the most important patents, has not yet been added, at least five and a half years later, it has taken the first step to change.
Patent information is still the most important part of the current industry call for joining the Purple Book.
It will still take a certain amount of time to realize it, but we can vaguely see that the more complete version 2.
0 is not so far away from us.

Attack, law

In terms of legislation, in the past year, whether at the federal or state level, a number of bills that encourage the use of biosimilars to benefit the public and save costs have been proposed or passed, which has greatly promoted and encouraged the follow-up of biosimilars.
development of.
Taking California as an example, two bills AB824 and SB852 have been signed into force in 2020.
The former is mainly aimed at the original biosimilar companies by paying part of the fees to biosimilar companies to delay the unfair competition of biosimilars entering the market, while the latter allows the state to enter the market.
Government medical institutions can contact biosimilar drug manufacturers to produce and distribute biosimilar drugs with their own labels (Cal Rx.
) in order to increase competition and reduce drug prices.

Seven, product performance

Adalimumab

The martyr's old age is full of enthusiasm.
The word surrender is never in the hero's dictionary.
Just when everyone felt that 20 billion would be the pain of Humira's life, the pain of Yaowang in 2020 continued the suspense.
Relying on the price increase strategy in the context of continuous sales growth in the US market, Abbvie has significantly eased the unfavorable situation of sluggish sales in the European-based patent expiration market, and successfully pulled global sales back to 19.
832 billion.
It is another step away.
This time, more is lost because the new crown epidemic suppressed the increase in the income of the new patient module.
It's been less than two years since the end of 2023, and there is really not much time left to stay with the drug king.

Humira's global sales over the years (100 million U.
S.
dollars)

In 2020, the overall price of Humira in the US market has increased by about 8% compared to the previous year, and the share of sales in the total global revenue continues to rise to 81.
2%, the highest in the past 17 years, second only to 87.
8% in the first year of listing.
The sales volume has successfully exceeded 10 million.
From the perspective of packaging, there are currently two packaging forms of injection pens and prefilled syringes.
The former's sales share further increased to 87.
5% last year; from the perspective of specifications, the overall share further increased to 100mg/ml.
The transfer of specification products has increased from 48% in 2019 to 72%, becoming another barrier to the original research against biosimilar drugs.
Compared with the first approved 50mg/ml product, the 100mg/ml product launched by Abbvie in 2016 has changed its prescription.
The removal of citric acid reduces the pain of patients during injection and is more convenient to use.
Alvotech was the first to declare a large-format product of 100mg/ml in the United States at the end of 2020, laying a solid foundation for subsequent market competition.
However, multiple biosimilars previously approved only include small-format products of 50mg/ml.
.
Coherus' BLA was reviewed by the FDA in February this year.

Bevacizumab

Hold the beauty of the world, with a fragrance in your hand, and not panic in your heart; if you lose your beauty and collapse the world, you will lose your soul.
Time is a pig-killing knife.
After all, the former king can't hide from the erosion of the years.
Looking back, his eyes are full of the shadow of the powerful situation of the year, a bit sad and a little lonely, brothers don't cry, at least you have been here.
With the complete defeat of all regions in the world, the infinitely glorious three-piece Roche tumor finally bid farewell to the altar this year.
Avastin, the only glorious survivor in 2019, has seen global sales plummet by 30% in the past year, ending the journey of 2020 with 4.
992 billion Swiss francs (equivalent to 5.
3 billion US dollars).
The United States has been fully penetrated by the second-year student Mvasi, and Europe has encountered the emergence of three biosimilar drugs.

Avastin's global sales over the years (100 million U.
S.
dollars)

In 2020, the sales revenue of the original research product Avastin in the US market was 1.
795 billion Swiss francs (approximately US$1.
9 billion), down 37%, and its regional share of global revenue fell 40% for the first time in the past ten years.
With the good performance of Amgen's bevacizumab biosimilar drug Mvasi in the past year, sales soared from US$121 million in 2019 to US$656 million.
Pfizer's Zirabev is limited to a low share of annual revenue of only $63 million.
In terms of sales volume, the overall sales of bevacizumab in the U.
S.
market in 2020 increased by 2.
5% compared to the previous year, slightly surpassing 2 million units.
Among them, Mvasi's share soared from 4% in 2019 to 36%, becoming the current year.
With the fastest penetration growth rate of biosimilar drugs, the share of the original research product Avastin has fallen to 60%, and the share of Zirabev, which has been on the market for one year, is only 4%.
In terms of specifications, the gap between 100mg/4ml and 400mg/16ml specifications is not large, with the former slightly dominant with a share of 51.
6%.
The overall market price has fallen further, and the current lowest average selling price (from Mvasi) has dropped to US$49.
9/10mg, which is equivalent to 73% of the price of the original research product.

In addition to Mvasi and Zirabev, which are currently on sale in the city, many others are also eye-catching.
Except for Centus, Samsung Bioepis and Mylan, which have been declared in 2019 and have not been approved yet (the FDA is limited by the new crown epidemic and cannot conduct on-site inspections), China's Biotech also submitted a BLA application for its biosimilar drug BAT1706 in 2020.
Another Chinese force Cinda and Coherus and Amneal and MAbxience are expected to complete the bevacizumab biosimilar in the United States this year.
According to the declaration, the follow-up Celltrion product is already in Phase III clinical phase, and the competition in the US market for this product will intensify in the future.

Trastuzumab

The one-year renewal period in exchange for the patent settlement is still coming.
Although this day will come sooner or later, although the pain at this moment is not as sad as the loss of the love of Europe last year, but when this moment really comes, Herceptin’s My heart is still full of endless hesitation and loss.
The combined efforts of five biosimilar drugs in the US market became the last straw that overwhelmed Herceptin.
The dual decline of the US and European markets announced the end of an era.
In 2020, Herceptin's global sales will eventually remain at 3.
732 billion Swiss francs (equivalent to 4 billion US dollars), a 34% drop compared to the previous year, and it has become one of the most tragic characters in the original biological research circle in the past year.

Herceptin's global sales over the years (100 million US dollars)

In 2020, the sales revenue of the original research product Herceptin in the US market was 1.
356 billion Swiss francs (about 1.
44 billion U.
S.
dollars), a 47% decline compared to 2019.
According to the previous settlement agreement, the three biosimilar products of Teva, Merck and Pfizer were successively launched in the first half of last year, and Herceptin became the first original product in the U.
S.
market that faced 5 competing biosimilars at the same time.
The sales of Kanjinti, the first biosimilar drug that ventured on the market last year, reached 475 million U.
S.
dollars, leading the biosimilars with a 17% annual sales share.
Amgen finally reached a settlement with Genetech, and the only lawsuit against trastuzumab was completely settled.
In 2020, the overall US market sales of the product fell to 1.
75 million, of which 85% came from 150mg small-format products.
Mylan ranked second with a 4% market share, and the share of the three newly listed companies was relatively small.
With the continuous penetration of biosimilars, the overall share of trastuzumab biosimilars in the fourth quarter of last year has reached 36%, and this figure is expected to further increase to more than 40% in 2021.
The current lowest average selling price (from Mylan) has dropped to US$57.
2/10mg, which is equivalent to 65% of the price of the original research product.
In addition to the current sales in the city, the trastuzumab biosimilars of Tanvex, Sandoz/eirgenix and Prestige are already in the phase III clinical stage.
my country's Fuhong Henlius granted Accord the US and Canadian commercialization rights of its trastuzumab biosimilar HLX02 last year, further expanding the scope of cooperation, and is expected to enter the US market in the future after exporting to Europe.

Rituximab (Rituximab)

As the world's first anti-tumor monoclonal antibody to be marketed, it is also the earliest product in the Riche three-piece kit and the highest historical sales peak.
Roche's original product Mabthera/Rituxan (used in the European and American markets respectively) has also been in the past year Suffered heavy losses, global sales fell by 31%, and maintained a surprisingly similar rate of decline with Avastin and Herceptin.
The brothers’ "together with adversity, advance and retreat" stepped in unison.
Compared with the other two products, the U.
S.
market is more important to Rituxan, and its share of the global share has always remained above 50%.
In 2018, the European crash was still desperate, and the United States was completely unable to recover.
day.
In 2020, Mabthera/Rituxan's global sales fell to 42.
23 Swiss francs (approximately US$4.
5 billion).

Overview of Mabthera/Rituxan’s global sales over the years (US$100 million)

In 2020, the sales revenue of the original research product Rituxan in the US market was 2.
864 billion Swiss francs (approximately US$3.
05 billion), which was 32% lower than in 2019 and accounted for 67.
8% of the global sales of the original research product.
Teva has increased its sales to nearly 400 million U.
S.
dollars by virtue of being the first to be listed and having all the indications approved by the original research.
After the settlement between Pfizer and Genetech, it launched its biosimilar drug Ruxience this year.
Although the conditions for the settlement lacked RA indications, Still achieved good sales of 164 million US dollars.
In 2020, the overall U.
S.
market sales of this product dropped to 2.
2 million units, 57% of which came from small-format products of 100mg/10ml.
The original research's annual share dropped to 74%.
Teva followed closely with a 17% share.
Pfizer Bottom with 9% share.
From a quarterly perspective, the share of biosimilar drugs in the fourth quarter of 2020 has increased to 44%, the share of Teva and Pfizer has reached 24% and 20%, and the share of original research has further dropped to 56%.
The current lowest average selling price (from Teva) has dropped to 58.
6 US dollars per 10mg, which is equivalent to 70% of the original research product price.

Amgen's Riabni was launched in January this year after the settlement.
There are currently three rituximab biosimilars on the US market.
In addition to the current sales in the city, in addition to Sandoz, which has already abandoned the US market, Archigen, which has completed phase III clinical trials, has abandoned the product due to unsatisfactory results.
The company was also shut down by joint venture partners Samsung and AZ at the end of last year.
.
Dr Reddy's, which develops this product for the European and American markets, is already in the phase III clinical stage.

Filgrastim

The 30-year-old veteran is still in the biopharmaceutical circle to exert his waste heat in itself.
At this time, the merits of the record are irrelevant.
With one year or less, it is a kind of feeling, a love from the beginning.
In 2020, the global sales of Amgen's original research product Neupogen declined for the eighth consecutive year, and it has fallen to US$225 million.
Sales in the US market, which accounts for 64%, are also expected to fall below US$100 million in the past two years.
The overall global decline The speed further dropped to 15%, perhaps the only news that can be used to masturbate.

Neupogen's global sales over the years (100 million U.
S.
dollars)

There have been no new biosimilar drugs on the US market for two consecutive years.
In the past 2020, there are still four mahjong bureaus.
Neupogen and Zarxio symbolize the inheritance of the new and old hegemony battle is still going on, but Neupogen in his twilight years can no longer turn the tide.
In 2020, the overall market volume of filgrastim in the United States has fallen to 2.
268 million, and the proportion of pre-filled syringe products has risen to 80%.
Neupogen achieved a revenue of US$144 million with a 28% sales share.
Zarxio further expanded its advantages after winning the lawsuit in 2019.
In the past year, it increased its share to 46%, becoming the only product that exceeded 100 million yuan in addition to the original research product.
It is also the product with the largest share of biosimilars currently on the market; Pfizer’s Nivestym is at the bottom with 8% share, and its two-and-a-half-year lawsuit with Amgen continues; Teva’s 351(a) product Granix’s share has fallen to 19 %.
The current lowest average selling price (from Sandoz) has dropped to $0.
357/1mcg, which is equivalent to 40% of the original price.
The BLAs of Kashiv and Tanvex have not been approved so far, and the relevant litigation has been terminated.

PEG-filgrastim

No port stays forever.
Neulasta, who appeared ten years later than Neupogen, also came to the intersection of his own phoenix blossoms.
The U.
S.
market, which accounts for more than 80% of the year, is finally unable to hold up under the background of successive failures in litigation.
The decline of nearly 30% for two consecutive years has opened the prelude to an era of gradual curtain call.
The process will not be fleeting, the sad helplessness and the afterglow of the setting sun are somewhat dazzling against the incomparable stubbornness of the past.
In 2020, Neulasta's global sales continued to decline to US$2.
293 billion (-28.
8%), and the US market accounted for 87.
3% of it.

Neulasta's global sales over the years (100 million US dollars)

In 2020, there are no new entrants in the U.
S.
market.
The situation looks similar to the four-way war of Filgrastim, but in fact it is more like a battle between Coherus and Amgen.
The overall market sales increased slightly to 1.
264 million, of which Amgen’s exclusive auto-injector Onpro accounted for 45%.
While delaying the penetration of biosimilar drugs, it also indicates to a certain extent a change in market demand in the future.
trend.

Coherus has increased its market share of Udenyca, the only product sold in the market, to 21% by virtue of its nearly 70 experienced sales team with two years of hard work.
If the original Onpro packaging is deducted, this figure will be further increased to 47%.
.
In 2020, Udenyca finally achieved sales of 476 million U.
S.
dollars, deducing the biopharmaceutical circle of "newborn calves are not afraid of tigers, not the first imitation, but also very good.
" In one year, Sandoz's Ziextenzo share was only 1%.
Pfizer's Nyvepria was launched in January this year and became the fourth pegylated filgrastim biosimilar in the US market.
Its litigation with Amgen is still ongoing, and the aforementioned three companies have won the lawsuit.
The current lowest average selling price (from Mylan) is about to fall below $2,000, and the price of the original research product has also been significantly reduced recently.
The product biosimilar MSB11455 of Fresenius has been reviewed by the FDA in May 2020.
It is also the first BLA declared in the United States for a generic injection drug and is expected to be approved this year; the product of Amneal and Kashiv is biosimilar.
The drug TPI120 is also in the FDA review process; in addition, Lupin plans to complete its BLA declaration by the end of this year.
Coherus and Fresenius have begun to develop auto-injector products similar to Onpro, and the penetration of biosimilar drugs will be further strengthened in the future.

Etanercept

When the defendant, "I'm sorry, I'll go to the market first, so you can sue you.
" When the plaintiff, "Want to go public? There is no door.
I don't accept the court.
" As one of the few original research leaders in the biosimilar drug circle, Amgen will vividly and vividly interpret a unique dual life.
"Knowing yourself and the enemy, a hundred battles are not dead, because I understand you, so I sue you", the lawsuit for Amegn is not so much a means, as a skill, not so much a tool, as an art, you have me in you , I have you in me, I want to compare with Tiangong test.
In 2020, Amgen won again.
With the circuit court's victory, it successfully blocked Sandoz's second wave of offense.
However, due to competition from other competitors in the same field and the impact of the new crown epidemic, U.
S.
revenue fell slightly last year.
At 4%, Pfizer suffered from enemies in Europe and continued to crash.
Adding together, Enbrel's global sales fell by 9%.

Enbrel's global sales over the years (100 million U.
S.
dollars)

In 2020, Enbrel's US market sales fell to 4.
855 billion U.
S.
dollars, accounting for 73% of its global sales.
It is difficult to face a real and powerful threat before biosimilar drugs enter the market.
The overall sales fell to 6.
758 million (-6 %), cushioning the impact on sales through price increase strategies.
From the packaging point of view, the product has four packaging forms: vials, cartridges, pre-filled syringes, and automatic injection pens.
Automatic injection pens have accounted for 62% of the total market, and ordinary pre-filled syringes are next with a share of 20%.
, The share of ordinary vials is less than 5%.

Sandoz, who was sued in the Circuit Court, still refused to give up.
At the beginning of this year, he initiated a request to the Supreme Court for review of the case, struggling to let go of the final fight, and if he fails again, he will have to wait another eight years.
Another biosimilar, Eticovo, which was approved in 2019, is also facing litigation and cannot be listed.
The lawsuit between Samsung Bioepis and Amgen is still in the district court.
In January this year, the court suspended the case at the request of both parties.
Coherus' previously in Phase III clinical phase of the etanercept biosimilar CHS-021 project limited to the patent results of reexamination is no longer continuing, and Lupin, which had planned to declare to the United States, is currently on hold.

Infliximab (Infliximab)

If Amgen makes everyone understand the importance of patent litigation for delaying the penetration of biosimilars, J&J has used practical actions to tell us that successful business operations are sometimes sharper than patent barriers, even if they are a bit ridiculous.
If a patent is approved, it’s not a problem.
After all, the rules on the surface must be followed.
You can only watch from a distance.
After sighing, you can always wait for the dawn to come.
The real internal injury is the silent pain of marrying someone else when she finally waits for the day when the gift is enough.
It hurts little and is extremely insulting.
In 2020, the global sales of the original research product Remicade fell by another 14% to 4.
57 billion.
The US market, which accounts for 62%, dropped to 2.
85 billion at almost the same rate of decline.
Even so, Remicade was launched five years after biosimilars.
It still occupies 85% of the market share, and the decline in sales is more due to the active downward adjustment of its own prices.

The "rebate trap" stimulus strategy has caused countless controversies.
The lawsuits between J&J and pfizer on unfair competition have not yet been concluded.
In fact, it is not so important whether or not to lose the lawsuit and the penalty is not so important.
Subsequent bio-similar drugs learned about the dangers of the world, and also made industry managers think more about it and began to make efforts to correct deviations.

Remicade's global sales over the years (100 million US dollars)

In 2020, the overall U.
S.
market sales of infliximab increased to 8.
36 million units (+3%).
Pfizer, which was already on the market in 2016, finally exceeded the 10% market share of Inflectra, although it was just surpassed.
Achieved sales of 341 million U.
S.
dollars; the share of Renflexis, the second listed company in 2017, finally exceeded 5% this year, achieving a sales and search revenue of over 100 million yuan; Amgen’s Avsola was also listed last year, becoming a three-year The only third biosimilar drug on the market is limited to the aforementioned various obstacles.
Although the penetration speed of biosimilar drugs is not satisfactory, it has achieved small but rare breakthroughs on the way forward.
The current lowest average selling price (from Pfizer) has dropped to US$45.
1/10mg, which is equivalent to 86% of the original price.
Sagent's NI-071 is currently the fastest-growing biosimilar drug developed for the US market.
Its phase III clinical trial has been completed, and the BLA declaration has been postponed to this year due to the impact of the new crown epidemic.

Epoetin Alfa/Epoetin Alfa

The most romantic thing I can think of is to grow old with you.
In a blink of an eye, Epogen, the eldest son of Amgen Biopharmaceuticals, is about to go through the 32nd year of his life, full of twists and turns of birth, standing proud of the world, and glory in the past.
Although the aura has faded, history will be remembered forever.
After the peak, after 18 years of continuous decline, Epogen/Procrit’s global sales have increased from 6.
5 billion to 1.
15 billion in 2020.
It is a life experience that gradually ages gracefully in calmness and peace.
Life is endless and struggle is endless.
There is still your legend in it.

Epogen/Procrit's global sales over the years (100 million U.
S.
dollars)

In 2020, the sales of epoetin alfa in the U.
S.
market has dropped to US$875 million (-15%), accounting for 76% of global sales.
Two original brand products with two indications, Epogen (from Amgen) and Procrit (from J&J, authorized by Amgen) contributed 68% and 32% respectively.
Since Pfizer’s biosimilar drug Retacrit was launched at the end of 2018, no new biosimilar drug has been approved.
In the past year, the overall sales of the product in the US market exceeded 10 million, and Retacrit’s market share has further increased to 38%.
The US market revenue reached 278 million US dollars, an increase of 98% compared to the previous year, accounting for 72% of its global sales.
There are no more reports on the subsequent progress of other companies that plan to develop biosimilar drugs for this product in the U.
S.
market.

8.
Future prospects

2020 is the tenth year since the BPCIA Act came into effect.
In this critical year of milestones, biosimilars have delivered a satisfactory report card with tenacious vitality against the background of the raging new crown epidemic.
Whether it is the conversion from NDA to BLA or the new high penetration level or the increasing improvement of pharmaceutical regulations, everything is progressing steadily and steadily towards a better future.
2020 is destined to become an important node in the history of the development of American biosimilar drugs.
.
In the blink of an eye, the first quarter of 2021 is about to say goodbye.
While feeling the time is like an arrow, I am not only looking forward to the future, a cup of respect for tomorrow, a cup of respect for the past, and you who are persistent on the road.

From a market perspective, it has been more than a year since the first biosimilars of the nine current products in the market were launched.
With the increasing regulation and circulation environment and the continuous improvement of recognition, the penetration of biosimilars will pass.
The speed has increased significantly in one year.
With the successive addition of new bio-similar drugs, the group advantage of bio-pharmaceuticals will be more obvious.
The competition of bio-similars for some products will reach more than 8 companies.
The competition will intensify and the penetration rate will be further accelerated.
The original research strategy of restricting biosimilar drugs through the introduction of new prescriptions and packaging forms can play a certain role in the short term, and the anti-restrictive targeted research and development of biosimilar drugs will dilute such barriers.
In addition to the existing biosimilar companies in the city, a group of leading small molecule generic drugs represented by Fresenius and Amneal will gradually enter the market in the next two years.
This change is not only a manifestation of the strength of pharmaceutical companies, but also reflects The current good development trend of the biosimilar drug market and the need for strategic upgrades of various companies after becoming bigger and stronger.

From the perspective of research and development, the research and development and registration of the first batch of explosive products born around 2000 have been saturated, and the layout of the first stage has fallen behind, and the research and development of the subsequent second batch of blockbuster has begun.
With the gradual accumulation of early-stage R&D experience of various companies, the launch of subsequent new products will be further accelerated, and anti-tumor and autoimmunity will continue to be two key areas.
Under the idea of ​​seeking benefits with speed, and taking into account the huge investment and risks of biological drugs, external introduction has gradually become the first choice for many biosimilar companies to expand their product lines.
With the addition of a wide range of protein products such as insulin, biosimilars in the future The types of medicine will be more abundant.

From the perspective of circulation, some insurances, doctors and patients have gradually begun to change their attitudes towards biosimilar drugs with the implementation of related educational activities and the actual landing of the cost-saving effect, and the continuous increase in acceptance has promoted the consumption of biosimilar drugs in the past.
Significant improvement in one year.
Nevertheless, limited to the limitations of the reimbursement policy and other links, biosimilars have not received equal coverage, and a large proportion of doctors and patients still have insufficient knowledge of biosimilars.
In the absence of effective incentive policies, Xia is still keen to use original research products.
The FDA's vigorous promotion and publicity through guidelines and related policies at the regulatory level, as well as regulatory support at the legislative level, will play a pivotal role in the further expansion of biosimilar drugs in the future, and interchangeability will remain the most important core discussion point at this level.
.

Time is silent, all doubts are broken, time is silent, and every miracle is witnessed.
Let's go on with the Yingsiaoyan dance of the most beautiful April sky in the world!

：FDA、CMS、IQVIA Midas、Cortellis、