This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without intervention of the prescribing healthcare provider. On October 29, Fresenius Kabi announced that the FDA granted an interchangeability designation for CONEXXENCE® and BOMYNTRA®…
On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen, Inc. (“Amgen”) and Biocon Biologics, Inc., Biocon Biologics UK Limited, Biocon Biologics Limited, and Biosimilars Newco Limited (collectively, “Biocon”) after Amgen and Biocon executed a Confidential…
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.” PYZCHIVA®—a biosimilar of Janssen’s STELARA®—is approved for the treatment of adults with plaque psoriasis, psoriatic arthritis, Crohn’s disease and pediatric plaque psoriasis for patients six…
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 issued a memorandum opinion construing the claim term “vaccine” in one of the asserted patents (U.S. Patent…
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, “Sarepta”). Genzyme alleges that Sarepta’s manufacture and sale of Elevidys® (delandistrogene moxeparvovec-rokl)—a gene therapy treatment for Duchenne…
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 IPRs filed by Celltrion where the PTAB found all challenged claims of U.S. Patent Nos. 8,580,264 and 10,874,677 were…
Below we provide an update on several ophthalmic anti-VEGF therapeutics currently being studied in clinical trials. EYLEA® HD (Aflibercept, 8 mg) Regeneron announced positive two-year (96 weeks) results from its PULSAR trial investigating Eylea® HD (aflibercept, 8 mg) with 12- and 16-week dosing regimens compared to EYLEA® (aflibercept, 2 mg)…
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 biosimilar to Biocon). Now, post-trial briefing is complete. The parties submitted their responsive briefs on July 24,…
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 candidate. Xbrane stated that “[t]he biosimilar candidate is a VEGF-a inhibitor, intended for the treatment of serious eye diseases such as…
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 since late last year—is used to treat neutropenia (low neutrophils, a type of white blood cell that fights infection)…