On August 25, 2023, Sandoz announced that the FDA has approved its biosimilar TYRUKO® (natalizumab-sztn), developed by Polpharma Biologics. TYRUKO® injection is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS). TYRUKO® is also indicated for inducing and maintaining clinical response and remission in adult patients…
On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept). As we previously reported, when Formycon submitted its aBLA in June 2023, it became the second biosimilar developer to announce…
Developing and successfully commercializing a biosimilar is a complex and expensive process. On September 13, 2023, in the first webinar in Goodwin’s 2023 Biosimilars Webinar Series, Goodwin IP Litigation partners and Big Molecule Watch editors, Naomi Birbach, Josh Weinger and Keith Zullow and, Goodwin IP Litigation associate and Big Molecule…
On August 29, 2023, the PTAB issued final written decisions in IPR2022-00578 and IPR2022-00579, filed by Celltrion on two patents related to tocilizumab — U.S. Patent Nos. 8,580,264 and 10,874,677, owned by Chugai Seiyaku Kabushiki Kaisa, Genentech, Inc, and Hoffmann La Roche, Inc. The ’264 patent claims are directed to…
It has been reported that Celltrion has finalized a settlement with Johnson & Johnson (“J&J”) in the United States relating to CT-P43, Celltrion’s ustekinumab biosimilar to J&J’s STELARA®, which would permit Celltrion to launch the product in the U.S. market on March 7, 2025, if approved by FDA. This settlement…
HHS has announced the ten drugs that will be included in the first year of the Inflation Reduction Act’s new Drug Price Negotiation Program. They are: Eliquis (apixaban, Bristol Myers Squibb) Jardiance (empagliflozin, Boehringer Ingelheim) Xarelto (rivaroxaban, Janssen Pharms) Januvia (sitagliptin phosphate, Merck Sharp Dohme) Farxiga (dapagliflozin, AstraZeneca AB) Entresto (sacubitril;…
The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. The statute sets a deadline of September 1, 2023 for the Secretary of Health and Human Services (HHS) to publish a list of the 10 drugs that will be subject to “negotiations” with the government to determine…
In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series, which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law. Stay tuned for more details, including registration information for upcoming webinars. So…
On August 18, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”), filed a petition for Inter Partes Review, IPR2023-01312, challenging the validity of claims 1-18 of U.S. Patent No. 10,464,992, assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). According to the petition, the ’992 patent claims “encompass a formulation comprising the VEGF inhibitor protein,…
GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO infringes four U.S. patents covering GSK’s rival RSV vaccine, AVREXY. According to the complaint, AVREXY and ABRYSVO were approved by the U.S….