July 28, 2021 – the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press release, SEMGLEE is indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and…
The results of a survey of board-certified rheumatologists in the United States about their beliefs and knowledge regarding biosimilar products were recently published in the journal Rheumatology. The online survey was conducted in May 2019 and included 19 multiple-choice questions assessing respondents’ knowledge of concepts and terminology concerning biosimilars, availability…
Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills. Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193. The Act directs pharmacists to dispense…
Yesterday, RAPS reported that the FDA is expecting the first interchangeable biosimilars to become available in the U.S. market within the next two years. Interchangeable biosimilars are those that “can be expected to produce the same clinical result as the reference product in any given patient.” In states with automatic substitution…
More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and Pennsylvania. On February 22, 2017, H 203 was signed into law in Montana. On March 10, 2017 HF 305 was signed into…
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”). The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the…
FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 – 2022, ahead of its upcoming public meeting on October 20, 2016 to discuss FDA’s proposed recommendations for the BsUFA reauthorization….
In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an interchangeability between biosimilars and their reference tumor necrosis factor-α (TNF-α) inhibitor counterparts. While this study only…
On July 20, Pennsylvania Governor Tom Wolf signed into law Senate Bill 514, which allows pharmacists to substitute for a brand name biological product a less expensive biosimilar product that has been deemed interchangeable by the FDA. Pennsylvania is the twenty third state to enact such a law. In particular,…
On September 17, 2015, Janet Woodcock, M.D., the director of the FDA’s Center for Drug Evaluation and Research, testified at a congressional hearing on the topic of biosimilars. A link to her written testimony is provided here, and a link to the video of the Q&A session is provided here….