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European Biologics Regulatory Updates

Bayer’s aflibercept 8 mg recommended for approval in Europe: On November 10, 2023, Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending aflibercept 8 mg for approval for extended treatment intervals in two major retinal…

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Recent Adalimumab Biosimilar Developments

FDA grants interchangeable designation to Pfizer’s adalimumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). ABRILADA was originally approved by the FDA in November 2019. The new interchangeable designation was…

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Bristol-Myers Squibb and AstraZeneca Settle Anti-PD-L1 Antibody Product Litigation

We previously reported on Bristol-Myers Squibb’s (“BMS”) complaint alleging AstraZeneca’s PD-L1 antibody product, IMFINZI (durvalumab), infringed U.S. Patent No. 9,402,899 (“the ’899 patent”). BMS alleged that the ’899 patent covers “Nobel Prize winning methods of treating cancer” by using “an antibody to inhibit the interaction between PD-1 and PD-L1 to…

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FDA Approves the Cyltezo Pen, an Autoinjector Option for Adalimumab

On May 22, 2023, Boehringer Ingelheim announced that the FDA has approved the Cyltezo Pen, a new autoinjector option for Cyltezo (adalimumab-adbm). According to a previous announcement from Boehringer Ingelheim, Cyltezo is an FDA-approved Interchangeable biosimilar to Humira (adalimumab) and its commercial license will begin on July 1, 2023. Initially…

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FDA Guidance on Continuous Manufacturing of Drug Substances and Drug Products

In March 2023, the FDA issued a final guidance, titled “Q13 Continuous Manufacturing of Drug Substances and Drug Products” that describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM).” CM refers to “the continuous feeding of input materials into, the transformation of…

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Coherus Biosciences Announces Approval of a Pegfilgrastim Autoinjector

On March 6, 2023, Coherus Biosciences announced FDA approval of an autoinjectable version of Udenyca, Coherus’ biosimilar to Amgen’s Neulasta (pegfilgrastim). Udenyca (pegfilgrastim-cbqv) was first launched in the US in January 2019 and is one of six FDA approved pegfilgrastim biosimilars. Udenyca is administered the day after a chemotherapy treatment…

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Samsung Bioepis Announces Approval of Citrate-Free, High-Concentration Adalimumab Biosimilar in Canada

On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). HADLIMA is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn’s disease, ulcerative colitis,…

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Janssen Files BPCIA Complaint Against Amgen Regarding Ustekinumab

On November 29, 2022, Janssen filed a BPCIA complaint in the District of Delaware against Amgen related to Amgen’s ustekinumb biosimilar ABP 654 of Janssen’s STELARA. This is Janssen’s first BPCIA case filed with respect to an ustekinumab biosimilar. Janssen alleges that its “scientists and clinicians spent decades developing STELARA…

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STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in Europe

On November 11, 2022, STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) announced that the European Commission has granted a marketing authorization for XIMLUCI (ranibizumab), a biosimilar to Genentech’s LUCENTIS. XIMLUCI is an anti-VEGF (vascular endothelial growth factor) for the treatment of retinal vascular disorders and has been approved…

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