On May 21, 2025, Sandoz announced the commercial launch in Europe of its PYZCHIVA® (ustekinumab) autoinjector, “the first ustekinumab biosimilar in Europe commercially available in an autoinjector.”...more
Back in May 2023, Alnylam brought suit against Pfizer and BioNTech in the District of Delaware, alleging infringement of patents directed to vaccine lipid nanoparticle technology. On August 12, 2024, Chief Judge Connolly...more
On July 26, 2024, Genzyme Corp. (a wholly owned subsidiary of Sanofi) filed suit in the District Court for the District of Delaware against Sarepta Therapeutics, Inc., and Sarepta Therapeutics Three, LLC (collectively,...more
On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals of the PTAB’s Final Written Decisions in IPR2022-00578 and IPR2022-00579. The appeals concerned...more
Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials....more
We previously reported on the opening post-trial briefs in Regeneron’s BPCIA case against Mylan and Biocon (who was added as a defendant after the original defendant, Mylan, transferred its rights to the aflibercept...more
On June 21, 2023, Xbrane announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Xbrane’s supplemental Biologics License Application (sBLA) for a LUCENTIS® (ranibizumab) biosimilar...more
Last week, Amneal announced the launch of FYLNETRA (pegfilgrastim-pbbk), a biosimilar to Amgen’s NEULASTA, in the United States. According to the press release, FYLNETRA—Amneal’s third biosimilar launch in the United States...more
On March 31, 2023, Mabwell announced that China’s National Medical Products Administration (NMPA) has approved MAILISHU, a denosumab biosimilar, for the treatment of osteoporosis in postmenopausal women at high risk of...more
Big Molecule Watch monitors for biosimilar clinical trial results. Here we report on four recent announcements concerning biosimilars of natalizumab, trastuzumab, daratumumab, and aflibercept....more
On February 8, 2023, Regeneron announced that the FDA approved its EYLEA® (aflibercept) injection for the treatment of retinopathy of prematurity (ROP) in preterm infants—the first pediatric approval for this indication. ...more
Amgen announced today the launch of AMJEVITA (adalimumab-atto), a biosimilar to AbbVie’s HUMIRA (adalimumab), in the United States. AMJEVITA was the first HUMIRA biosimilar approved by the FDA and is now the first to be...more
On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069. The PTAB ruled in...more