The FDA’s Center for Drug Evaluation and Research (CDER) announced on 18 February 2016 the release of the ‘FDA Overview of Biosimilar Products’. Although CDER’s primary mission is to make certain that safe and effective drugs are available to the American people, it also has a strategic initiative to inform and educate people about the safe use of medicine. This is done through its CDERLearn online training platform.

This latest continuing education course released by CDER provides an understanding of biologicals and biosimilars and a description of FDA’s general approach to the development and approval of biosimilars. The target audience for the course is healthcare professionals, including physicians, physician assistants, nurses, nurse practitioners and pharmacists.

The course aims to inform participants so that they are able to:

1. Identify the changes to the law granting FDA authority to review and license biosimilars
2. Define what biologicals and biosimilars are
3. Recognize the key terminology related to biosimilars
4. Describe FDA’s general approach to the development and approval of biosimilars

The course will count towards CME accreditation according to Accreditation Council for Continuing Medical Education (ACCME) requirements. The course is valid for credit through 17 February 2019 and is available at http://fdabiosimilars.e-paga.com/ 

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