Yesterday, the FDA announced the release of a 5-part video series designed to provide viewers a background of what biosimilar and interchangeable products are, the development and approval process for these products, and the tools and technologies that are used to demonstrate biosimilarity.
Yesterday, the FDA announced the release of a 5-part video series designed to provide viewers a background of what biosimilar and interchangeable products are, the development and approval process for these products, and the tools and technologies that are used to demonstrate biosimilarity.
The video series is just the latest in a broader education and outreach effort the FDA has been conducting in regard to biosimilar and interchangeable products. Some prior education materials include fact sheets, infographics, and a stakeholder toolkit. The goal of these materials is to educate healthcare professionals, patients, and other stakeholders on what these products are as well as ensuring safety and efficacy.
Each educational video features a specific topic and answers questions about biosimilars by multiple staff members of the FDA:
“The FDA will continue to play a prominent role in facilitating the efficient development and approval of high quality, safe, and effective biosimilar and interchangeable products,” according to the press release.
To date, the FDA has approved 10 biosimilars. The most recent approval was awarded to Pfizer’s epoetin alfa biosimilar, to be marketed as Retacrit.
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June 20th 2024The FDA has issued an update to its guidance on requiring switching study data for biosimilars to be granted interchangeability, citing new science that shows these studies aren’t needed to establish biosimilar safety.
British Columbia’s Biosimilar Switching Program Saves $732 Million in 5 Years
June 18th 2024British Columbia's 2019 Biosimilars Initiative, which transitioned over 40,000 patients from costly reference biologics to biosimilars, saved around $732 million in 5 years, maintained comparable health outcomes, and reinvested the savings to improve the province's public payer program.