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Are you hearing the term “biologic” with increasing frequency and need more details on this corner of the pharmaceutical world? Biologics are a rapidly growing sector of the drug market, composing 10% of new FDA approvals in 2005 and 32% of approvals in 2016. Biologics and copycat biosimilars are complex protein-based pharmaceuticals that cannot be manufactured as easily as their conventional drug counterparts. Biologics are costly to produce, and are a big part of the current national drug-pricing conversation. Before 2010, there was no FDA provision for licensing cheaper analogous versions of biologics. The Biologics Price Competition and Innovation Act introduced a path for biosimilar approval, but standards for achieving interchangeability status (allowance for the biosimilar to be substituted for the original reference biologic by a pharmacist) were strict and vague. In January 2017, the FDA issued new interchangeability guidelines for biosimilars, making it easier to develop a biosimilar that can be ordered at the pharmacy like a generic. This guidance discusses clinical trial designs unique to the arena of biologics/biosimilars.
At the conclusion of this webinar, learners will be able to
- Identify the differences between biologics and conventional drugs.
- Describe which regulations govern the manufacturing, approval, and distribution of biologics/biosimilars.
- Evaluate considerations exclusive to biologic/biosimilar/interchangeable clinical trial design.
Learning Level: Basic, Intermediate
Content Areas: Health and Medicine, Regulatory, Writing for Professional Audiences
About the Presenter
Dr. Mills is a medical writer for Whitsell Innovations, Inc., and has presented on the topic of biologics and biosimilars at internal company training sessions and at the AMWA 2017 annual meeting. She has presented on topics such as utilizing LinkedIn for scientific career development, T cell immunity, vaccine adjuvants, and anti HIV immune responses at over 15 local and international oral symposia. She is an immunologist and has supported pharmaceutical clients as a GLP study director and medical writer for over 6 years.