Last week, Samsung Bioepis Co., Ltd. and Organon & Co. announced that the FDA accepted for review their supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar referencing HUMIRA (adalimumab). The FDA previously approved SB5 under the brand name HADLIMA as a low-concentration…
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)….
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…
Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer. According to the press release, patients receiving sintilimab plus BYVASDA combined with chemotherapy (pemetrexed and cisplatin) demonstrated an improvement in progression-free…
As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products. The BPCIA also introduced a new scheme to resolve…
Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma (“NPC”) and toripalimab monotherapy for the second-line or above treatment of recurrent or metastatic NPC after…
On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.” According to FDA, the guidance…
Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027. We have previously reported on BsUFA rates for the 2022 fiscal year. The BsUFA authorizes FDA to…
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO) “pursuant to Executive Order 14036, and in the hope…