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Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

Final Judgment and Order of Permanent Injunction Entered in Immunex v. Samsung Bioepis Etanercept Biosimilar Litigation

The New Jersey district court in the Immunex v. Samsung Bioepis BPCIA litigation entered a Final Judgment and Order of Permanent Injunction on November 3, 2021.  As we previously reported, the litigation pertains to ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL.  The case had been administratively stayed since January 2020. Judgment…

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Innovent Announces Results of Phase III Trial of Sintilimab and Bevacizumab Combination Therapy In Patients With Advanced Lung Cancer

Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer.  According to the press release, patients receiving sintilimab plus BYVASDA combined with chemotherapy (pemetrexed and cisplatin) demonstrated an improvement in progression-free…

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FDA Approves First Interchangeable Biosimilar Insulin Product (UPDATE - 11/23/2021)

July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…

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Now Available! Updated Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…

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Ascletis and Suzhou Alphamab Expand their Partnership into Worldwide License Agreement for ASC22 (Envafolimab) to Treat Hepatitis B and Other Viral Diseases

Ascletis Pharma Inc. (Ascletis) and Suzhou Alphamab Co., Ltd. (Suzhou Alphamab) jointly announced that Ascletis’ subsidiary and Suzhou Alphamab have entered into an exclusive worldwide licensing agreement (excluding Greater China) for ASC22 (Envafolimab) to treat viral diseases, including Hepatitis B.  According to the press release, ASC22, also known as KN035,…

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First Biosimilar Making “Paragraph IV” Certification under China’s New Patent Law: Bio-Thera Solutions Announced NMPA Acceptance of aBLA for Tocilizumab

On November 8, 2021, Bio-Thera Solutions, Ltd. announced that China’s National Medical Products Administration has accepted the marketing authorization application for BAT1806, a biosimilar of Roche’s Actemra® (tocilizumab), which is a recombinant humanized monoclonal antibody targeting the interleukin-6 receptor (IL-6R).  Actemra® has been approved in the United States for the…

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Amgen and Pfizer Developing More Interchangeable Biosimilars

In their respective third quarter financial results, Amgen and Pfizer both announced plans to seek interchangeable status for select biosimilars.  Amgen announced that patients are currently being enrolled in Phase 3 studies to support interchangeability designation in the U.S. for biosimilars of AMJEVITA (adalimumab) and ABP 654 (ustekinumab).  Pfizer also…

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Coherus and Junshi Biosciences Announce FDA Acceptance of Toripalimab BLA

Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after…

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Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo.  Susvimo is a refillable ocular implant—requiring refills every six months—that continuously delivers medicine into the eye for the treatment of neovascular or wet age-related macular degeneration, a condition that can cause rapid and…

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