April Breyer Menon, Author at Venable's BiologicsHQ

DOJ Files Amicus Brief in Moderna COVID-19 Vaccine Patent Appeal

by April Breyer Menon | Jul 20, 2026

On June 19, 2026, the U.S. Department of Justice filed an amicus brief on behalf of the United States in Arbutus Biopharma Corp. et al. v. Moderna Inc. et al., No. 26-1581 (Fed. Cir.), supporting Moderna’s appeal from the district court’s ruling on 28 U.S.C. §...

Accord Announces FDA Approval of Neulasta® Biosimilar Ennumo™

by April Breyer Menon | Jul 13, 2026

On July 9, 2026, Accord announced the May 2026 FDA approval of Ennumo™ (pegfilgrastim-pccg), a biosimilar of Amgen’s Neulasta® (pegfilgrastim). Ennumo™ is the eighth Neulasta® biosimilar to be approved in the U.S. According to Samsung Bioepis’s Q2 2026...

Celltrion’s Truxima® Approved as First Interchangeable Rituxan® Biosimilar

by April Breyer Menon | Jul 3, 2026

On July 1, 2026, Celltrion announced that the FDA designated Truxima® (rituximab-abbs) as interchangeable with Genentech’s Rituxan® (rituximab). Truxima® was first approved as a biosimilar in November 2018 and is the first Rituxan® biosimilar to receive an...

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv® / Xbryk® (denosumab-dssb) / Stoboclo® / Osenvelt® (denosumab-bmwo) / Conexxence™ / Bomyntra™ (denosumab-bnht) / Bildyos® / Bilprevda® (denosumab-nxxp) / Bosaya™ / Aukelso™ (denosumab-kyqq) / Enoby™ / Xtrenbo™ (denosumab-qbde) / Osvyrti® / Jubereq® (denosumab-desu) / Boncresa™ / Oziltus™ (denosumab-mobz) / Ponlimsi™ (denosumab-adet)

by April Breyer Menon | Jun 30, 2026

Download PDF *Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh)

by April Breyer Menon | Jun 30, 2026

Download PDF *Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they are challenged...

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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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