Biosimilars are intricate in their makeup and the process for FDA approval is even more multidimensional. Todd Cooperman’s (PharmD, MBA, R.Ph.) recent whitepaper provides insight into biosimilars in the U.S. healthcare marketplace. Below is a caption from the introduction of the whitepaper.
Initial Food and Drug Administration (FDA) guidance on the biosimilar pathway was intentionally vague, to allow for the development of the evaluation process. Since this initial approval the process of evaluation has been evolving as more biosimilar applications are reviewed. Part I of this white paper will focus on an overview of the current biosimilar market, the challenges of bringing a biosimilar to market, and discuss medical reimbursement for biosimilars. Part II will focus on how key stakeholders; patients, providers, and payors, may be affected by the challenges of biosimilar medical benefit management.
Below are highlights of sections within this paper that will be expanded on:
- A review of the biologic drug patent expiration landscape and pipeline will provide insight into potential product introductions through
2020 that will impact market competition
- Cost savings from biosimilar approval is estimated at $44 billion for the US market by 2024
- FDA review and approval of biologic vs. traditional drugs – A brief overview of the differences in FDA approval of biologics vs. traditional
drugs and how this impacts product launches
- Interchangeability and statutory restrictions – Generics typically are interchangeable when approved, but biosimilars require additional FDA
review, which is further regulated at the state level
- Medical reimbursement for biosimilars – CMS plans to reimburse Medicare medical claims for biosimilars at (ASP) plus 6% and maintain the innovator exclusive HCPCS or J-Code