BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS

Exclusively for subscribers of Biosimilar Development, our content collections bundle articles centered around a particular topic or theme. These carefully curated selections feature content from both our internal team of editors as well as our subject matter experts who contribute regularly to the site.

  • From Drugs To Biologics: Considerations For The FDA’s Insulin Transition

    In line with a Congressional directive, the FDA must transition products previously approved as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to biologics under the Public Health Service Act (PHS Act) by March 23, 2020. Though this directive applies to 90 soon-to-be biologic products, including growth hormones, the insulin products have been garnering the most attention. Following this transition, biosimilar makers investing in follow-on biologics to current branded products will have their products approved via the 351(k) biosimilars pathway. Novel products will be transferred to the 351(a) biologics pathway. This collection of articles examines the upcoming regulatory transition in depth, sharing industry and patient perspectives on the changing regulatory requirements and market access strategies and concerns for this critical class of medicines.

  • Biosimilar Education Strategies for Physicians And Clinicians

     

    Free collection of articles highlighting some of the dynamics playing out in the hospital setting for biosimilars, as well as how physicians and drugmakers can foster a greater understanding of biosimilar medicines.

  • U.S. Biosimilar Regulatory Progress: Are We Making Progress?

     

    Biosimilar approvals in the U.S. are being granted at a quicker pace, but the allure of tailored biosimilar development that lowers or eliminates dependence on large comparative clinical trials remains a long-term, highly sought-after goal. This free collection of articles examines several of the FDA’s most recent high-profile guidances and how certain regulatory decisions will (or will not) advance the biosimilar industry.