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. 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.