Development review and future trends of biosimilars

Guide: Biosimilar manufacturers may continue to take advantage of the "patent dance" over the next decadeTo prevent the embarrassment of biosimilars from being approved until 12 years after the original product entered the market
Wei Jiaxian and Zhang Jiandrug research and development is generally divided into original research drugs and genericdrugsThe scope of the original drug generally includes: 1Completely innovative new drugs (First-in-class) designed for known or new targets, and 2New drugs designed for known targets that differ from existing drug structures (Best-in-class, Me-too, Me-better)generics are a new class of drugs that are similar in quality, safety and efficacy to the original drug, and can be divided into two categories: chemical generics and biosimilarsAmong them, biosimilars are biological drugs with similar functions with bioprimary drugs, the general principles should be the same as the amino acid sequence of the original drugEurope began approving biosimilar applications early, and the U.Sonly came into a law in 2009 devoted to the regulation and litigation of biosimilars:the Biologics Price Competition and Innovation Act (BPCIA), which was approved in March 2010the bill was formed primarily to resolve patent disputes over biosimilars and to promote the development of innovative biological drugsin short, biosimilar manufacturers and bioprimary drug manufacturers can determine through the FDA whether a patent expires and if there is an infringement, which is known as the "patent dance" ()In addition, the FDA protects biosimilars from actually being marketed without being affected by patent litigation the current bill has been in place for 10 years, and we can probably know what to think about the future of biosimilars by reviewing biosimilar approvals over the past 10 years as of December 2019, the FDA approved a total of 26 biosimilar products, compared with 10 in 2019 These include nine biosimilars of biological drugs that are clinically important Currently, 15 approved biosimilar products are on the market Fda-approved biosimilars include: recombinant human granulocyte seisitens ,filgrastim), glycogen recombinant proteins (Epogen), polyethylgylized proteins (Neulasta), quercetin (Herceptin), and Humira biosimilars that are available in the U.S a Forecast 2024 sales data b Full compliance with patent dance c Partial compliance with patent dance d Non-compliance with patented dance Biosimilars have grown rapidly in recent years
Sandoz Inc.'s generic Neupogen drug Zarxio as the first biosimilar, approved by the FDA five years after the adoption of the BPCIA Act Janssen's company Remicade is the first biosimilar monoclonal antibody (mAb) product to enter the market in 2016 as a bombshell drug treatment for rheumatoid arthritis and Crohn's disease Celltrion/Pfizer's biosimilar Remicade biosimilar Inflectra, which went on sale in 2017, offers twice the price discount on the original drug, mainly due to a 35 percent reduction in wholesale acquisition costs (WAC) to 15 percent There are currently seven biosimilar products in the United States, and the average WAC of biosimilars is 10%-37% lower than bioprimary drugs, and the price discount for the second and third products of the same biosimilar is usually lower than the first and some biosimilarpatent patent litigation is completed, the company concerned has launched a number of biosimilars biosimilars can also be approved as new biologics for use in new clinical indications by extrapolation For example, a manufacturer's biosimilar products have already demonstrated a new indicationoutcome, so it can be extraduced that it has a bioprimary approved indication, so that it does not need additional testing in other indications This provides a great convenience for biosimilar manufacturers, avoid the waste of repeated testing in each indication the decade of the development of biosimilar litigation
in the past decade, the development of litigation channels biosimilar products has matured the general process of litigation for biosimilars is that, after the FDA accepts its application for review, the biosimilar manufacturer sits on regulatory and manufacturing information to biooriginal drug companies, exchanging positions on infringement and effectiveness, and negotiating which patents to claim, which is the "patent dance" in the BPCIA Act, which has been following the biosimilar manufacturers' own claims to comply from the start Among them, some biosimilar manufacturers have completely bypassed the litigation route, did not provide any information to the original research drug manufacturers, so that the original drug manufacturers without clear information to sue biosimilar manufacturers Sandoz's Neupogen biosimilar was the first of its kind and has been appealed to the Supreme Court In June 2017, the Supreme Court finally upheld the decision by biosimilar manufacturers to completely bypass the "patent dance", but noted that compliance with the "patent dance" could help biosimilar manufacturers provide important control over the timing and scope of litigation Currently, most biosimilar manufacturers follow the way in the BPCIA bill, and even before the Supreme Court's ruling, most of them follow the BPCIA act biosimilar manufacturers may continue to take advantage of the "patent dance" over the next decade To prevent the embarrassment of biosimilars from being approved until 12 years after the original product enters the market This approach will also allow bio-original and biosimilar manufacturers to produce in a mutually informed manner, providetime and impetus for innovation and renewal of biopharmaceutical products but with the market share of the problem, once the biosimilars in advance in the market , will inevitably affect the market share of bioprimary drugs, resulting in the loss of the interests of bioprimary drug manufacturers this is yet to be seen in the further refinement of the BPCIA bill in the light of the problems that have been revealed It is hoped that the future development of biosimilars will have a better balance between patents and the market references
1.Irena Royzman et al.10 of the Biolikes : Lessonsand Trends.Nat Rev Drug Discov.2020, 19 (6): 375.doi: 10.1038/d41573-020-00081-5.
2.D?rner T, Kay J.Biolikes in rheumatology : current sr and lessons learnt Nat Rev Rheumatol.2015,11 (12): 713-24.doi:10.1038/nrrheum.2015.110.
Responsible Editor: Kerry Labels: global , biosimilars 00
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