Accord’s aBLA for Proposed Biosimilar DMB-3115 Accepted by FDA

by April Breyer Menon | Jan 24, 2024

According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab), a proposed biosimilar to Janssen Biotech’s (a Johnson & Johnson company)...

Venable’s BiologicsHQ Monthly Injection – December 2023

by April Breyer Menon | Jan 13, 2024

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BPCIA Complaint Against Proposed Soliris® (eculizumab) Biosimilar SB12 Filed

by April Breyer Menon | Jan 11, 2024

On January 3, 2024, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) filed a BPCIA litigation in the District of Delaware (Case No. 1-24-cv-00005 (D. Del.)) against Samsung Bioepis Co. Ltd. (“Samsung Bioepis”)...

EYLEA® (aflibercept) and Soliris® (eculizumab) IPR and BPCIA Litigation Updates

by April Breyer Menon | Dec 31, 2023

Soliris® (eculizumab) On December 8, 2023, the PTAB instituted three of Samsung Bioepis’s pending IPRs against Alexion’s Soliris® (eculizumab), IPR2023-00933 (for U.S. Patent No. 9,732,149), IPR2023-00998 (for U.S. Patent No. 9,718,880), and IPR2023-00999 (for U.S....

Celltrion Completes Application for FDA Approval of CT-P41, Biosimilar of Prolia® / Xgeva®

by April Breyer Menon | Dec 19, 2023

On November 30, 2023, Celltrion announced that it filed for an abbreviated Biologics License Application (aBLA) for FDA approval of CT-P41 (denosumab), a proposed biosimilar of Amgen’s Prolia® / Xgeva® (denosumab). There is currently another pending aBLA for a...

EYLEA® (aflibercept) IPR and BPCIA Litigation Updates

by April Breyer Menon | Dec 15, 2023

There has been a flurry of activity relating to proposed EYLEA® (aflibercept) biosimilars in November, starting with a BPCIA litigation against Celltrion’s proposed biosimilar CT-P42 filed on November 8, 2023, Case No. 1:23-cv-00089 (N.D.W.Va.) (see BPCIA Litigation...

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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