April Breyer Menon, Author at Venable's BiologicsHQ

Alvotech Announces First FDA Acceptance of aBLA for Proposed Entyvio® Biosimilar – AVT16

by April Breyer Menon | Jun 11, 2026

On June 8, 2026, Alvotech announced that the FDA accepted for review its abbreviated Biologics License Application (“aBLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s Entyvio® (vedolizumab). AVT16 is the first publicly announced aBLA accepted by the...

Keytruda Qlex™ Updates: PTAB Finds Additional Halozyme PH20 Patent Unpatentable in Final Written Decision

by April Breyer Menon | Jun 11, 2026

On June 8, 2026, the Patent Trial and Appeal Board (“PTAB”) issued a Final Written Decision (“FWD”) in PGR2025-00004 finding all remaining challenged claims of Halozyme’s U.S. Patent No. 12,018,298 (“the ’298 patent”) unpatentable. The ’298 patent was challenged...

Supreme Court Clarifies Standard for Pleading Inducement of Patent Infringement in Hikma v. Amarin

by April Breyer Menon | Jun 10, 2026

On June 4, 2026, a unanimous Supreme Court in Hikma Pharms. USA Inc. v. Amarin Pharma, Inc., No. 24-889, clarified the standard for pleading induced patent infringement under 35 U.S.C. § 271(b). Although Hikma dealt specifically with an inducement claim against a...

aBLA Resubmissions: Xbrane’s Xlucane (ranibizumab) and Alvotech’s AVT05 (golimumab) and AVT06 (aflibercept)

by April Breyer Menon | Jun 6, 2026

On June 3, 2026, Xbrane announced the resubmission of its aBLA for Xlucane (ranibizumab), a proposed biosimilar of Genentech’s Lucentis® (ranibizumab) after receiving a second Complete Response Letter (CRL) from the FDA in October 2025. Xbrane previously submitted...

FDA Approves Lupin’s Ranluspec™ (ranibizumab-hkdz) as Fourth Interchangeable Biosimilar of Lucentis®

by April Breyer Menon | Jun 4, 2026

On June 2, 2026, the FDA approved Lupin’s Ranluspec™ (ranibizumab-hkdz) as the fourth interchangeable biosimilar of Genentech’s Lucentis® (ranibizumab). According to Lupin’s press release, this is the first interchangeable ranibizumab biosimilar to be approved...

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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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