Biosynthic drugs enter the collection to speed up! ShuMeile, Roche strong enemy ring waiting

On the first working day after the Spring Festival holiday, CDE released a heavy message: "Biosynlike Drug Similarity Evaluation and Adaptive Extratroller Technical Guidelines" was officially released, which means that the pace of domestic biosypoxic drugs into the belt procurement accelerated.
data show that China's bio-similar drug market size will reach 58.9 billion yuan by 2030, individual products will reach 10 billion.
industry forecasts that in the next three years, more than 30 to 50 biosypolisic drugs are expected to be on the market, the competition is far more intense than PD-1.
Adamu single resistance, lytoxi monoanti, curt bead monoanti, beval bead single resistance and other heavy biological drugs strong enemy ring.
Biosynthic Drug "Consistency Evaluation" came into the collection and was speeded up on February 18, the State Drug Administration Drug Review Center (CDE) official website issued the "Biosyspole Drug Similarity Evaluation and Adaptation Extratrophic Technical Guidelines", which the industry called the biosynthic drug version of the "consistency evaluation" policy. the
guidance document points out that, because biological products have the characteristics of large molecular weight, complex structure, strong dependence on biological activity on the structural integrity of their structure, and complex production process, in order to further standardize and guide the development and evaluation of biosynlike drugs and promote the healthy development of the biopharmaceutical industry, the guiding principles on the basis of the Technical Guidelines for Biosynthic Drug Research and Evaluation (Trial) further supplement the guiding recommendations for biosynthic drug similarity evaluation and externalization, with the aim of providing technical references to industry, researchers and regulators.
It is noteworthy that the guidance document specifically defines the "similarity" of biosynthic drugs compared to last August's draft , where candidates are similar to approved reference drugs as a whole and there are no clinically significant differences in quality, safety and effectiveness.
In addition, for the industry's general concern about the overroting of adaptations, the document requires that this should be based on the overall similarity between the candidate drug and the reference drug, when a direct clinical trial proves that the candidate drug is clinically similar to the reference drug in at least one adaptation, it may be through the scientific argumentation of the research data and information related to the extratrophic adaptation to support its use in reference drugs approved in China other non-directly studied adaptations.
The extraterrence of adaptive disorders cannot be obtained directly, and the similarities and differences in pathogenesis, pathophysiology and so on between the studied adaptation and the proposed extratrophics should be considered on a case-by-case basis according to the characteristics of the drug action mechanism, and the similarity ratio of the study data.
because of the particularity of biosimilars themselves, industry analysts have previously pointed out that unlike generic drugs, which can evaluate the quality and efficacy of generic drugs, biosimilars require similarity evaluations.
drug generics need to pass a consistent evaluation before they can be collected nationwide.
this time, the National Health Insurance Administration officially issued guidelines for the evaluation of biosypole similarities and the extraterrive technology of adaptive drugs, most likely in preparation for the next biosypolytic drugs to carry out volume procurement.
the time is ripe for the collection of biologically similar drugs? China's bio-similar drug research and development started late, in 2015 the domestic bio-similar drug regulations gradually clear, single-resistance research and development from innovation declaration to similar drug declaration, more and more enterprises began to lay out biological products.
potential competition in the biopharmaceder and biosypolyte markets.
the current national drug collection has been carried out to the fourth batch, the next year two batches will also become the norm.
those who are familiar with the collection rules are aware that volume procurement can save drug marketing and promotion costs and increase drug sales and revenue for new entry, although the level of gross margin is low, but overall can improve the profitability of enterprises.
biosynthic drugs are included in the volume procurement, will undoubtedly also be good for new enterees, the future is still a small number of players in the market.
domestic pharmaceutical companies are expected to increase market share through import substitution or penetration.
, however, the industry has previously had a different view of bioso-like drugs for carry-on procurement.
Reported in August last year that biosimilar barriers are much higher than generic drugs, and that the development of domestic similar drugs is still in its infancy.
Comparing drugs only need to carry out BE's core trial after the expiration of the original research patent, biosimilar drugs not only need to demonstrate the similarity of clinical and non-clinical in vitro data, but also need to compare clinical effectiveness, and the extraterroration of the adaptation does not rule out the need for additional trials, its clinical development costs (including the opening of clinical costs and the cost of purchasing the original research drugs, etc.) are much higher than the generic drugs.
Despite the large number of domestic biosynthic drug development enterprises and the phenomenon of pile-up of popular targets, globally, there is still no consensus on the substitution between similar drugs and primary research, between similar drugs and similar drugs, and involves the core issues of adaptive extraterrition.
Pacific Securities believes that in the short term for the collection of biosynthic drugs is still more difficult, in the current competitive environment to determine the sales pattern of the factors will be the academic promotion capacity of enterprises.
However, shortly after the opening of the fourth batch of state tenders in February this year, Chen Jinfu, deputy director of the State Health Insurance Administration, responded to the relevant questions at a regular policy briefing of the State Council, saying, "There are differences in the quality evaluation of generic drugs with biosimilars, but it has strict quality standards, and there is no doubt that the next step is to include them in the collection."
explored some places and the quality of the selected products is completely controllable..."
It is also worth recalling that, on October 9, 2020, the State Health Insurance Administration, in response to the "Recommendations on Speeding Up the Level of Medical Security for Diseases such as Psoriasis" of the Third Session of the 13th National People's Congress, made it clear that it was studying the policy of centralized procurement of biological products, that biosic drugs were not a restricted area for centralized procurement, and that centralized procurement would be carried out in due course.
the first working day of the Lunar New Year, the guiding principles for the evaluation of the similarity of biosynthic drugs and the extraterring techniques of adaptive diseases were officially launched, and it is probably only a matter of time before biosypolytic drugs are included in the collection.
of popular varieties of biological medicine collection - Adam, lysoxi, curto beads... In recent years, domestic enterprises for bio-similar drugs research and development heat.
relevant statistics, China has nearly 300 biosic drugs in different stages of research and development, of which Adamo monoanti, lytoxi monoanti, quarto bead monoanti, beval pearl monoanti, Invlixi monoanti, etc. belong to the popular research and development varieties.
Adamu single resistance, including the original research manufacturer AbbVie, the current number of domestic approved enterprises up to 5, respectively, There are Baiotai, Haizheng Pharmaceuticals, Xinda Bio, Fuhong Hanxuan, in addition to Junshi Bio and China Biopharmaceutical biosimilar drugs are also in the review and approval.
In the patent expired, bio-similar drugs have been approved for listing, in 2020 Shumeile is still firmly at the top of the list, Shumeile again close to $20 billion, but Shumeile also has hidden worries, the growth rate is not optimistic, only 3.5%.
Evaluate Pharma had forecast that global sales could fall to $6.83 billion by 2026.
fast-growing K drug is also reported to replace Shumeile as the "king of medicine" in the future.
's market for Adamo monobial-like drugs will grow to 4.7 billion yuan in 2023 and 11.5 billion yuan in 2030, according to a report by Frost Sullivan.
With more and more biosynthic drugs on the market, Shumeile's market share in China will also be gradually squeezed, has entered the health insurance directory of Adamo single resistance, if included in the collection, the subsequent price will be more people-to-people.
addition to the most money-making Shumeile, Roche's super-heavy oncology "troika" has also been in the public eye.
Its three ace drugs, Rituxan (Meriva, generic name: rituxy monoantigen injection), Herceptin (Herceptin, generic name: injection cratin monoantigen) and Avastin (Avistin, generic name: Beva bead monoantigen injection), also face patent expiration and increasing competition.
Roche's three ace drugs, lytoxi single resistance, beva bead single resistance in the domestic has formed a competitive pattern of 1 plus 2, of which beva bead single resistance, including Hengrui medicine, including 4 are about to be approved for listing, strong enemy ring waiting.
addition, according to the FDA Biosychables Database, as of December 2020, 10 of the nearly 30 biosynthic drugs approved by the FDA had been targeted at Roche's three ace biologics.
Roche's 2020 financial results show that sales of the three aces, Beval Pearl Single Resistance and Lytoxi Single Resistance, all shrank below SFr5 billion in 2020, falling more than expected, from -38%, -29% and -35% year-on-year, respectively, to a cumulative decrease of CHF 6.6 billion in 2020.
recently, Evaluate Pharma forecast the 2021 hot drugs, Roche's Merova, Avetin have fallen out of the top 10, the top 10 list by Theomera, Corrida, Refumei, Alto, Alja, Odivo, Starano, Itovi, Eko, Byrto occupied.
Under the fierce impact of biosynthic drugs, Roche's former ace drugs will be difficult to follow the glory of the past, with the advent of bio-similar drug similarity evaluation and the development of volume procurement, the future competitive environment will be more intense.
There is no doubt that the introduction of centralized procurement of biological products related policies and rules will have their own "play", but once the volume of procurement, the domestic market will face reshuffle, the overall industrial structure of biological products is expected to be optimized adjustment, it remains to be seen.