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

The first working day after the Spring Festival holiday, CDE released a heavy message: "Biosic drug similarity evaluation and adaptation extratrophic technical guidelines" officially announced, which means that the pace of domestic biosypolytic 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, in the next three years, the domestic is expected to have more than 30 to 50 biosic drugs will be listed in succession, competition is far more intense than PD-1. Adamo single resistance, lysoxi single resistance, curt bead monoanti, beval bead single resistance and other heavy biological drugs strong enemy ring.Biosynthic drug "consistency evaluation" cameinto the collection and then speed upFebruary 18, the State Drug Administration Drug Review Center (CDE) official website released the "Biosic drug similarity evaluation and adaptation extratrophic technical guidelines", the document is called by the industry 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 of biological activity on its structural integrity and complex production process, in order to further standardize and guide the development and evaluation of biosynthic drugs and promote the healthy development of the biopharmaceutical industry, the guiding principles on the basis of the Technical Guidelines for The Development and Evaluation of Biosynthic Drugs (Trial), further supplement the guiding recommendations for biosypole drug similarity evaluation and adaptation, aimed at providing technical reference for industry, research and development and regulatory agencies.It is noteworthy that the guidance document specifically defines the "similarity" of biosynthic drugs compared to last August's draft - candidate drugs are similar to approved reference drugs as a whole, and there are no clinically significant differences in quality, safety and ability.In addition, for the industry's general concern about the adaptation extraterror, the document requires that this should be on the basis of the candidate drug and the reference drug as a whole similar, when directly compared to clinical trials to prove that the candidate drug is clinically similar to the reference drug in at least one adaptation, may be through the extratrophic adaptation-related research data and information of scientific argumentation, to support its use in reference drugs approved in China other non-directly studied adaptation. The introphysic extraterrence can not be obtained directly, and the similarity between the pathogenesis, pathophysiology and so on between the drug action mechanism, the study of the similarity between the adaptive disease and the proposed extratrophication, and the similarity ratio should be considered on a case-by-case basis.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 need to be evaluated for similarity. Chemical 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 biosynthic similarities and the extraterrive technology of adaptive diseases, most likely in preparation for the next biosypolytic drugs to carry out volume procurement.Is it ripe for biosynthic drugs to be collected?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. There is potential competition in the biopharmaceder and biosypolysed drug market.At present, the national drug collection has been carried out to the fourth batch, the next year two batches will also become the norm. Those familiar with the collection rules already know that volume procurement can save drug marketing and promotion costs and increase drug sales and revenue for new buyers, although the level of gross margin is low, but overall can improve the profits of enterprises.Biosic drugs are included in the volume of procurement, no doubt can also be good for new players, 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. Previously, however, there had been a different view in the industry of carry-on procurement of bioso-like drugs.Pacific Securities reported in August last year that biosimilar barriers are much higher than chemical generics, 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 extrasoposed on the adaptation does not rule out the need for additional trials, its clinical development costs (including the opening of clinical costs and the purchase of original drugs, etc.) are much higher than the generic drugs.Although there are more bio-similar drug development enterprises in China, and the hot targets show a pile-up phenomenon, but from a global perspective, the replacement between similar drugs and the original research, similar drugs and similar drugs has not yet reached a consensus, and involves the core issues of adaptation extraterrition. Pacific Securities believes that in the short term for the collection of biosynthic drugs is still difficult, in the current competitive environment to determine the sales pattern of the factors will be the academic promotion capacity of enterprises.However, in February this year, shortly after the opening of the fourth batch of state tenders, Chen Jinfu, deputy director of the State Health Insurance Administration, responded to the relevant questions at a regular briefing on state policy, "Biosimilars and chemicals of generic drug quality evaluation methods are different, but it has strict quality standards, the next step into the collection is beyond doubt." Some places have been explored, 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 Third Session of the 13th National People's Congress "recommendations on accelerating the level of medical security for diseases such as psoriasis", made it clear that it is studying the relevant policies for centralized procurement of biological products, bio-similar drugs are not a restricted area for centralized procurement, and will carry out centralized procurement in due course. On the first working day of the Lunar New Year, the guiding principles for the evaluation of the similarity of biosynthic drugs and the extra-technology of adaptation were officially launched, and it is probably only a matter of time before biosypolytic drugs are included in the collection. Biological drug collection popular varieties prediction - adamu, lysoxi, curtoju ... In recent years, domestic enterprises for bio-similar drugs research and development heat. Relevant statistics, China has nearly 300 bio-similar drugs in different stages of research and development, of which Adamo monoanti, lysoxi monoanti, quarto bead monoanti, beval bead monoanti, Invlixi monoantigen, etc. belong to the popular research and development varieties. Adamo 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 biosimilars are also in the review and approval. With patents expiring and biosynthic drugs approved for listing, Shumeile remains firmly at the top of the list in 2020, with Shumeile once again approaching $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. The faster-growing K drug is also reported to replace Shumeile as the "king of medicine" in the future. China's market for Adamo monobiotics will grow to 4.7 billion yuan in 2023 and 11.5 billion yuan in 2030, according to 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 catalog of Adamo single resistance, if again included in the collection, the subsequent price will be more people-to-people. In 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 (Merivale, generic name: rituxy monoantigen injection), Herceptin (Herceptin, generic name: injection of virto-bead monoantigen) and Avastin (Avistin, generic name: Beva bead monoantigen injection), also face patent expiration and a growing number of competing products. 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. In 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 CHF 5 billion in 2020, falling more than expected, from -38%, -29% and -35% YoY, respectively, and by 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 Shumeile, Corida, Refumei, Alto, Alja, Odivo, Starano, Vitovy, Eke, Bairto occupied. Under the fierce impact of biosynthic drugs, Roche's former ace drugs will also be difficult to continue the glory of the past, with the advent of biosypolor 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 biological products centralized procurement-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. (
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