Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®. The proposed natalizumab biosimilar is for treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS). The application is for an intravenous…
On July 26, Prestige Biopharma Limited (“Prestige”) announced a partnership with Intas Pharmaceuticals Limited (“Intas”) and its affiliate Accord Healthcare to commercialize Prestige’s bevacizumab, HD204, a proposed biosimilar to Roche’s AVASTIN®, in the United States, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan, and…
On July 11, 2022, Teva filed a cert petition with the Supreme Court, seeking review of the Federal Circuit’s split per curiam opinion holding that Teva’s label for its generic drug Coreg induced doctors to infringe a GSK method-of-use patent, despite having a “skinny” label carving out the sole patented…
On Monday, Hikma announced a partnership with Celltrion to market YUFLYMA (CT-P17) in the Middle East and North Africa. CT-P17 is a high-concentration, low-volume and citrate-free adalimumab biosimilar, indicated for the treatment of a number of conditions including rheumatoid arthritis, ankylosing spondylitis, and Crohn’s disease. According to Hikma, CT-P17 provides…
Last week Alvotech announced that it has initiated a confirmatory study for its biosimilar candidate to EYLEA®, AVT06 (aflibercept). EYLEA® is indicated for treating a variety of eye disorders including wet AMD, macular edema, and diabetic retinopathy. According to Alvotech, the study “is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence…
On Thursday, July 7, 2022, California Governor Gavin Newsom announced that the most recent state budget, signed last week, includes a $100 million allotment for California to “contract to make [its] own insulin at a cheaper price, close to at cost.” The budget designates $50 million for the development of…
On July 6, 2022, Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published her response to the letter sent by Janet Woodcock (former acting FDA Commissioner) to the former Director of the USPTO, Andrew Hirshfield. Concurrently, Director Vidal and Commissioner Califf published a blog…
Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and 26 of U.S. Patent No. 10,130,681, and IPR2022-01226 challenging claims 1-9, 34-39, 41-43, and 45 of U.S. Patent No….
Goodwin is actively seeking Science Advisors to join its Intellectual Property (IP) Litigation group. IP litigation requires both an understanding of the law and a firm handle on the technical aspects of the patents at issue, especially when the patents cover complex technologies including those in the pharmaceutical space. “Science…
On July 5, Mylan announced another voluntary recall of a batch of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens “due to the potential for the label to be missing on some pens.” The recalled product is not the branded SEMGLEE® pen, but rather the unbranded…