On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech. The biosimilar, also referred to as
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AbbVie Inc. et al. v. Alvotech hf. Updates
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf. (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the second wave suit, on December 21, 2021, AbbVie filed a Second Amended Complaint
FDA Accepts Samsung Bioepis’ and Organon’s sBLA for their Citrate-Free, High-Concentration HUMIRA (Adalimumab) Biosimilar Candidate
Last week, Samsung Bioepis Co., Ltd. and Organon & Co. announced that the FDA accepted for review their supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar referencing HUMIRA (adalimumab). The FDA previously
PTAB Institutes Two IPRs on Tocilizumab Patents
China Accepts Innovent Biologics’ Supplemental New Drug Application for Sintilimab Plus Bevacizumab Biosimilar Injection
On December 24th, 2021, Innovent Biologics announced that China’s National Medical Products Administration had accepted its Supplemental New Drug Application (sNDA) for TYVYT®, a sintilimab plus bevacizumab biosimilar injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC)
Health Canada Approves Celltrion’s Adalimumab Biosimilar, YUFLYMA
According to various reports, Celltrion has received approval from Health Canada for YUFLYMA, a biosimilar of AbbVie’s HUMIRA product. YUFLYMA was previously approved in Europe, and is a high-concentration, low-volume, citrate-free formulation of adalimumab.
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Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021
Year in Review: Top-Five U.S. Biosimilar Market Developments of 2021
Sandoz submits BLA for proposed biosimilar trastuzumab to the FDA
Last week, Sandoz announced that it submitted a Biologic License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) to the FDA. According to the press release, the biosimilar trastuzumab was developed by EirGenix, Inc. pursuant to
Year in Review: Top Legal Developments of 2021 Impacting Biosimilars
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal