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...
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...
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...
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...
by April Breyer Menon | May 31, 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...