by April Breyer Menon | Aug 19, 2024
On August 12, 2024, Sandoz announced the FDA approval of Enzeevu™ (aflibercept-abzv) as the fourth biosimilar of Regeneron’s EYLEA® (aflibercept). Enzeevu™ was approved as provisionally interchangeable, subject to the unexpired first...
by April Breyer Menon | Aug 10, 2024
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by April Breyer Menon | Aug 8, 2024
On July 26, 2024, Genzyme filed a complaint (“Complaint”) against Sarepta Therapeutics (“Sarepta”) in the District of Delaware. Genzyme Corp. v. Sarepta Therapeutics, Inc., No. 1:24-cv-00882 (D. Del.). In its complaint, Genzyme alleges that Sarepta infringed...
by April Breyer Menon | Jul 31, 2024
On July 24, 2024, Bio-Thera Solutions announced the FDA acceptance of its aBLA for BAT2206 (ustekinumab), a proposed biosimilar of Janssen and Johnson & Johnson’s Stelara® (ustekinumab), with a request for interchangeability. This aBLA is the seventh...
by April Breyer Menon | Jul 31, 2024
On July 8, 2024, Regeneron, Mylan, Celltrion, and Apotex jointly stipulated to the dismissal of CAFC Appeal Nos. 23-1395 and 23-1396, appealing the Final Written Decisions finding all challenged claims of U.S. Patent Nos. 9,254,338 and 9,669,069 unpatentable in...