Regulatory

The Center for Biosimilars® recaps the top stories for the week of March 30, 2020.
Matt Harman talks about employer interest in biosimilar promotion and how the FDA's new biologics pathway change will affect interest levels, during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.
Wayne Winegarden, PhD, talked about the issues and benefits of the FDA's switch to a biologics regulatory pathway for certain products, especially insulin, during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.
Sheila Frame, the vice president of marketing, market access, and patient services at Sandoz, discusses US biosimilar policies in development and the impact they will have on the market at the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California.
The Center for Biosimilars® recaps the top stories for the week of March 9, 2020.
In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.
 
The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.
Looking to March 23, the FDA released a question-and-answer guidance document for industry about the upcoming transition for how certain products will now be approved under a biological pathway, including exceptions to the transition and how companies will receive notifications about their applications.
The FDA announced changes or updates to several policies. Chief among them: final guidance on a regulatory shift for insulin and certain other products.
The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.

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Health economics experts. Managed care professionals. Key clinical specialists. This is where the worlds of clinical, regulatory, and economical outcomes for specialized pharmaceutical biotechnology meet: The Center for Biosimilars is your online resource for emerging technologies, with a focus on improving critical thinking in the field to impact patient outcomes. We’ll discuss the current landscape for advanced health care management—reviewing emerging treatment paradigms, approaches, and considerations—all by authoritative industry voices.

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