April Breyer Menon, Author at Venable's BiologicsHQ

PTAB Denies Institution of Two Sarepta IPRs Related to Elevidys®

by April Breyer Menon | Nov 17, 2025

On November 6, 2025, the Patent Trial and Appeal Board (“Board”) issued decisions denying institution of Sarepta Therapeutics’ IPR2025-01194 against claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent) and IPR2025-01195 against claims 1-4, 6-7 and 11...

FDA Approves First Perjeta® Biosimilar: Shanghai Henlius Biotech / Organon’s Poherdy®

by April Breyer Menon | Nov 14, 2025

On November 13, 2025, the FDA approved Shanghai Henlius Biotech / Organon’s Poherdy® (pertuzumab-dpzb) as the first interchangeable biosimilar of Genentech’s Perjeta® (pertuzumab). Poherdy® is approved for all of the same indications as Perjeta®. There is an ongoing...

Hikma Announces Launch of Stelara® (ustekinumab) Biosimilar Starjemza™

by April Breyer Menon | Nov 9, 2025

On November 6, 2025, Hikma announced the U.S. launch of Starjemza™ (ustekinumab-hmny), a biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Starjemza™ is approved for all the reference product’s indications, including certain...

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FDA Moves to Accelerate Biosimilar Development and Lower Drug Costs in New Draft Guidance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On October 29, 2025, the FDA released a new draft guidance “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy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...

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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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