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Breaking Down the FDA’s Biosimilars Action Plan: Biosimilars and You

Back in July 2018, the FDA released their Biosimilars Action Plan. This plan aimed to help create competition in the marketplace, increase innovation in biosimilar development and further build the positive reputation of biosimilars with patients and doctors alike.

The FDA recognized a need for a more timely approval process in the biosimilar market while lowering cost and increasing overall access to these products. Our health care system and patients are the main beneficiary for this new action plan with the FDA being hopeful that the approval of more biologic similars can lead to the treatment of even more serious illnesses.

Key Elements of the Biosimilars Action Program

Improving the efficiency of the biosimilar and interchangeable product development and approval process

The FDA is actively looking for ways to improve the efficiency of the biosimilar approval process. One way the FDA is doing this is streamlining the approval process by making information more readily available. In addition, they transitioned the Therapeutics Biologics and Biosimilars (TBBS) to the Office of Therapeutic Biologics and Biosimilars (OTBB) which allows improved communication, accelerated response times and new policy development and implementation.

Maximizing scientific and regulatory clarity for the biosimilar product development community

The FDA wants communication regarding biosimilars to be timely, well-structured and most of all – clear. One of their priorities for this specific key element is making sure they provide easy to comprehend information about approved biological products in a more modernized, interactive version of the Purple Book. The FDA will also help support a global market for biosimilars in order to gather insight about real world safety and efficacy.

Developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors

Since biologic medicine is one of the quickest growing areas in drug spending it is important patients, clinicians and payors know what products they are getting their hands on. The FDA has released various campaigns and webinars to allow interested parties to receive correct information about biosimilars. Many of these are available on the FDA Biosimilars website or on various streaming websites. The FDA also wrote that they plan to host more in the future.

Supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition

One of the most important aspects of the Biosimilars Action Plan is allowing competition in the marketplace. This competition allows affordable drug prices for consumers. The FDA has worked with and will continue to work with Congress to allow healthy competition to continue. The FDA is also taking many ideas from their Drug Competition Action Plan and applying it to the Biosimilars Action plan to stomp out anticompetitive strategies of any kind.

Avomeen’s Biologics Analysis Expertise

Avomeen’s expertise and experience in biologics analysis makes us an invaluable partner. Our team has expertise in all stages of biologics research and development from early discovery to IND, BLA and beyond. We work with our partners to determine what methods and instruments will help achieve set goals. Avomeen has in in-house protein biochemistry, molecular biology, cellular biology, and QC. If you’re interested in partnering with us on a future biologics analysis project, connect with us.

Additional Resources

Learn more about why biologics help make drugs more affordable in our blog, The Path to Affordable Biologic Drugs: Analytical Considerations.

Avomeen recently hired a new Biological Chemistry Project Director, Khanh Ngo Courtney. Read about her experience and qualifications in her announcement, Avomeen Hires New Biological Chemistry Project Director.

Are you evaluating service providers or looking for a new CRO or CDMO? Our blog, Your CRO/CDMO Can and Should Do More than Deliver Data, provides some guidance.

Filing an ANDA with the FDA anytime soon? If so check out our blog, Good ANDA Submission Practices.



Our featured blogger is Khanh Ngo Courtney. Khanh provides clients with unparalleled expertise and tactical knowledge of protein biochemistry and molecular biology. Her experience extends from R&D to analytical method development, validation, implementation, method transfer, and optimization of test methods for the cGMP setting per USP and ICH guidelines.