The fifth domestic adalimumab approved!

On January 20, the official website of the State Food and Drug Administration showed that the adalimumab biosimilar declared by Chia Tai Tianqing was approved for marketing
.
According to public information, this is the fifth adalimumab biosimilar drug approved for marketing in China.
Together with AbbVie’s original research drug Humira, 6 domestic adalimumab products have been approved
.
In recent years, the domestic biosimilar drug industry has developed vigorously with the strong support of the regulatory authorities, and the process of product development and listing of enterprises has been significantly accelerated.
After the centralized collection of insulin and growth hormone, monoclonal antibody biosimilars will not escape the fate of centralized collection
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After insulin and growth hormone, centralized procurement of similar drugs or accelerated implementation Including large varieties of biological drugs in centralized procurement is undoubtedly a top-level institutional requirement and an important measure for the reform of medical insurance payment in the new era
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On January 29, 2021, Guobanfa [2021] No.
2 was announced, and it is clear that it will explore the merger of different generic drugs with similar indications or functions to carry out centralized and volume-based procurement
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"Considering the actual indications or functional indications without considering the generic name" is interpreted by the industry as focusing on tailor-made for the centralized procurement of Chinese patent medicines and biological products
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Today, the industry's voice for the inclusion of biological drugs in centralized procurement has become increasingly louder
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Following the recently completed sixth batch of national procurement for insulin products, the Guangdong Provincial Drug Trading Center officially released the "Guangdong Alliance Diclofenac and Other Drugs Concentrated Procurement Documents" the day before, which will include blood products, recombinant human growth hormone in the The 276 drugs included in the list are included in the scope of volume procurement, which further ignited the industry's attention to the centralized procurement of biological drugs
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It is not difficult to feel that the pace of centralized procurement of large varieties of biological drugs represented by insulin and growth hormone is accelerating.
The basic conditions are also maturing
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Since 2019, biosimilars of rituximab, adalimumab, bevacizumab, and trastuzumab have been approved for marketing, involving Henlius, Hisun Pharmaceutical, Bio-Thera, Qilu Pharmaceutical, Innovent Bio, etc.
Among them, rituximab, adalimumab, and bevacizumab have met the number of 3 or more, and have all met the conditions for centralized collection
.
At present, the competition for biosimilars of adalimumab in China is the most intense.
In addition to Chia Tai Tianqing, there are also four domestic companies including Bio-Tech, Borui Bio (Hisun Pharmaceutical), Innovent Bio, and Henlius.
Approved; in addition, there are more than 10 domestic companies that are developing adalimumab biosimilars, and the product listing applications of Junshi Bio and Shenzhou Cell have been accepted
.
It is generally believed in the industry that the approval of a number of adalimumab biosimilars will further enrich clinical treatment options at a more competitive market price and improve drug accessibility for patients, thereby triggering a reshuffle in the domestic market, and a positive impact on the market.
AbbVie's original research drug Humira caused direct competitive pressure
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Humira is known as the "Global Drug King".
It has ranked first in the world's best-selling drug rankings for nine years since its launch, and will contribute nearly $20 billion in revenue to AbbVie in 2021
.
Under the fierce impact of biosimilars in the United States, Europe and other markets, AbbVie began to pay attention to the incremental market in China
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Since 2019, through medical insurance negotiation, Humira has dropped from RMB 7,600 to RMB 3,160, a drop of nearly 60%
.
Even so, compared with the global market, Humira still cannot meet the needs of patients and the market due to factors such as fewer approved indications, drug availability and disease treatment rates in China
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In the face of the increasingly fierce competition from local biosimilars in China, the future seems to be not easy for "Drug King" to maintain the market performance it has achieved in the past
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The original research cannot escape the fate of layoffs, "Drug King" or follow suit? Obviously, as the original research company of adalimumab, the price and market tests that AbbVie faces are only a microcosm of the multinational pharmaceutical companies in China's industrial ecology in the new era
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Under the implementation of policies such as medical insurance negotiation, bidding and centralized procurement, original research drugs are facing the dual pressure of comprehensive substitution and substantial price reduction
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Industry experts have pointed out that regardless of whether the original research drugs of multinational pharmaceutical companies win the bid or not, the overall market sales will face huge challenges
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In fact, from December 6, 2018, when the “4+7” pilot city drug centralized procurement was opened in Shanghai, to November 26, 2021, the sixth batch of national centralized procurement (special insulin) bids were opened, and the national procurement has gone through 3 years.
In the past year, a total of six batches and seven rounds of centralized procurement have been carried out, and the scope of implementation has been expanded from 11 cities to the whole country.
From the very beginning, multinational companies have been "indifferent" to the national centralized procurement, and have begun to change their identities and attitudes.
participants
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Taking the fifth batch of national mining as an example, a total of 218 varieties were included, of which the 10 billion-level blockbuster varieties include atorvastatin, clopidogrel, acarbose, etc.
11 products of foreign-funded enterprises were selected, including original research manufacturers such as Braun, GlaxoSmithKline, Sanofi, GE Healthcare, etc.
, as well as international generic pharmaceutical companies such as Teva and Sun Pharmaceuticals of India
.
In terms of varieties, among the fifth batch of multi-national enterprise products that won the bid, three products fell by more than 80%, namely Sanofi's oxaliplatin for injection (82.
36%) and Tanabe Pharmaceutical's beetastine besylate.
Tablets (81.
58%), Cephalon's bendamustine hydrochloride for injection (80%); two products with a drop of less than 50% are Teva's alfacalcidol soft capsules (32.
03%), Alfacalcidol Softgels (30.
15%)
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Even if they do not enter the centralized procurement, multinational pharmaceutical companies are struggling to cope with the sharp price cuts by local companies
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Since April 2020, Sanofi has significantly lowered the prices of besartan, hydrochlorothiazide tablets and clopidogrel tablets in Beijing, Shanghai, Chengdu, Chongqing and other cities by about 60% and 70% respectively.

.
In addition, Bayer's acarbose tablets have also joined the price reduction.
The dosage form of a box (50mg, 30 tablets) was previously priced as high as 61.
29 yuan, and the adjusted price was 5.
42 yuan, a price reduction of more than 90%.

.
The dramatic changes in the market structure brought about by falling prices have further put multinational pharmaceutical companies under increasing operating pressure, thus accelerating the adjustment of their business team structure, and even directly triggering a "wave of layoffs"
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Previously, multinational pharmaceutical companies such as AstraZeneca, Daiichi Sankyo, Eli Lilly, Novo Nordisk, and Sanofi have released news of "structural adjustment", and "n+x" compensation has even become a hot topic in the industry
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It is foreseeable that AbbVie may also make "structural adjustments" once the centralized procurement of biosimilars begins
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In fact, its "architectural adjustment" has precedent
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In 2019, AbbVie announced that it would cut 178 jobs at Stemcentrx
.
The company is a venture-backed oncology drug company acquired by AbbVie for $5.
8 billion in 2016.
Its original intention was to enrich the anti-tumor drug system and help get rid of its dependence on the star product Humira
.
However, judging from the current situation, AbbVie still has not really stepped out of the performance inertia of the "King of Medicine" Humira
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Competitive pressure of global similar drugs in 2022, "Drug King" down the altar? In addition to the market impact caused by medical insurance negotiations and national centralized procurement in China, the "King of Medicine" Humira is facing greater pressure in the global market
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According to the forecast of evaluate Pharma, a global pharmaceutical market research organization, although Humira will still occupy the top position of the world's top 10 best-selling drugs in 2021, the sales of "potential blockbusters" such as Keytruda and Dupixent are growing rapidly, and the title of "Drug King" may soon be easy.
Lord
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From its approval for listing in 2003 to the end of June 2020, Humira has brought AbbVie a total of $165.
8 billion in revenue, still accounting for nearly 60% of the company's sales, and its importance is self-evident
.
However, the competitive pressure brought by biosimilars to Humira on a global scale has always attracted attention
.
In fact, AbbVie has prepared for many years to deal with Humira's "patent cliff", through patent strategy, negotiation, litigation and other means, even building a "patent fence" to prevent biosimilars from being listed in the United States, which has been regulated, Market, industry, patient disputes
.
In September 2017, AbbVie signed the first Humira biosimilar agreement with Amgen, which will be the first to launch biosimilars in the U.
S.
market in January 2023, and biosimilars from other drugmakers will follow.
It will enter the U.
S.
market at different times in 2023
.
So far, AbbVie has signed at least 8 agreements, including Boehringer Ingelheim, Mylan, Sandoz,
etc.
In May last year, the U.
S.
Senate Oversight and Reform Committee held a hearing with AbbVie’s CEO and relevant experts, focusing on the price of adalimumab “Humira” and ibrutinib
.
The committee's investigation concluded that, in order to establish and maintain the market monopoly of "Huminox" and ibrutinib, AbbVie has repeatedly raised drug prices and used the US patent system to prevent adalimumab biosimilars from entering the market
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In addition, AbbVie is also actively looking for alternative products of "Drug King" to make up for the sales gap caused by the "patent cliff" in the future
.
Taking the field of autoimmune disease treatment as an example, Skyrizi and Rinvoq have high hopes
.
However, getting what you want is not easy
.
As a JAK inhibitor, although Rinvoq has just been approved for the treatment of adults 12 years and older with moderate-to-severe atopic dermatitis and adolescent patients 12 years and older after the US FDA review delay attaches great importance to the safety of clinical use
.
Whether the new drug can take over the status of the "King of Medicine" remains to be verified by time
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Experts believe that, with the exception of the United States, Humira's monopoly position in the global market is gradually being challenged by numerous biosimilars, and 2022 will be the last revelry before Humira enters the "patent cliff"
.
Whether it is the challenge of blockbuster new drugs in the world or the price competition of biosimilars, Humira may step down from the altar of "Drug King" in a short period of time
.