April Breyer Menon, Author at Venable's BiologicsHQ

FDA Issues Complete Response Letter for Alvotech’s Simponi® (golimumab) Biosimilar AVT05

by April Breyer Menon | Nov 6, 2025

On November 2, 2025, the FDA issued a complete response letter (CRL) for Alvotech’s abbreviated Biologics License Application (aBLA) for its proposed Simponi® (golimumab) biosimilar AVT05. The CRL stated that certain deficiencies were identified after the FDA’s...

FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs in New Draft Guidance

by April Breyer Menon | Oct 31, 2025

On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies” designed to accelerate the development of...

Regeneron Settles Litigations with Celltrion over EYLEA® Biosimilar Eydenzelt®

by April Breyer Menon | Oct 23, 2025

On October 20, 2025, Celltrion and Regeneron announced they reached a settlement agreement, dismissing Case Nos. 1-23-cv-00089 (N.D.W. Va.) and 1-24-cv-00053 (N.D.W. Va.) / MDL 1:24-md-03103 (N.D.W. Va.) and allowing the commercialization...

PTAB Grants Institution of Four PGRs related to Merck’s Keytruda Qlex™

by April Breyer Menon | Oct 19, 2025

Beginning in November 2024, Merck Sharp & Dohme, LLC (“Merck”) requested post-grant review (“PGR”) of 14 patents owned by Halozyme, Inc. (“Halozyme”), with claims directed to modified PH20 hyaluronidase polypeptides, including modified polypeptides that exhibit...

FDA Approves Celltrion’s EYLEA® Biosimilar Eydenzelt®

by April Breyer Menon | Oct 16, 2025

On October 9, 2025, Celltrion announced the FDA approved Eydenzelt® (aflibercept-boav), a biosimilar of Regeneron’s EYLEA® (aflibercept). The FDA has previously approved five aflibercept biosimilars: Biocon / Mylan’s Yesafili™ (aflibercept-jbvf), Samsung...

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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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