As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year: 1. President Biden Signs Orange Book Transparency Act In January, we reported that President Biden signed H.R. 1503 (the Orange Book Transparency Act of 2020). The Orange Book Transparency Act requires NDA holders to…
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2021. Here are our top five: 1. SEMGLEE Launches As First-Ever Interchangeable Biosimilar In July, the FDA approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin-glargine-yfgn), a biosimilar to LANTUS (insulin glargine)….
Last week, Sandoz announced that it submitted a Biologic License Application (BLA) for a proposed biosimilar trastuzumab (150 mg, for intravenous use) to the FDA. According to the press release, the biosimilar trastuzumab was developed by EirGenix, Inc. pursuant to a 2019 license agreement that gives Sandoz the right to…
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, at the PTAB, and even at the ITC. Biosimilars…
On Monday the FDA approved Eli Lilly’s insulin glargine biosimilar Rezvoglar, a biosimilar to Sanofi’s Lantus. Rezvoglar is indicated to improve glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Rezvoglar is available in 3 mL prefilled pens and…
Earlier this year, AbbVie Inc. and AbbVie Biotechnology Ltd. filed a Complaint against Alvotech hf. in the US District Court for the Northern District of Illinois alleging theft of trade secrets relating to adalimumab. In October, AbbVie’s complaint was dismissed for lack of personal jurisdiction. AbbVie has appealed that ruling. In addition…
Today, Coherus BioSciences, Inc. announced that the FDA approved YUSIMRY (adalimumab-aqvh), a biosimilar of AbbVie’s HUMIRA product. YUSIMRY is indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. According to the press release, Coherus plans to launch YUSIMRY in the U.S….
On December 8, Samsung Bioepis announced that it had presented the longest follow-up study results for a trastuzumab biosimilar in patients with HER2-positive early or locally advanced breast cancer. The five-year study compared long-term survival rates of patients on SB3 (ONTRUZANT®, Samsung Bioepis’ biosimilar of Herceptin®) and Herceptin® (trastuzumab) from…
Eris Lifesciences (“Eris”) announced its joint venture with Mumbai-based MJ Biopharm Pvt Ltd. (“MJ”), Eris MJ Biopharm Ltd., focused on the marketing and distribution of insulins (including aspart, glargine and lispro), GLP1 agonists, and potentially other biopharma products in India. Under the agreement, MJ will be responsible for the development,…
We have previously reported on AbbVie’s first and second wave suits against Alvotech hf (Alvotech) in the Northern District of Illinois regarding an adalimumab biosimilar. In the first wave suit, on October 5, 2021 AbbVie moved to dismiss Alvotech’s counterclaims and affirmative defenses of inequitable conduct, unclean hands, and patent…