Since 2013, Biosimilars Review & Report (BR&R) has tracked FDA biosimilar approvals, pipeline developments, clinical trials, biosimilar policy decisions, and market access trends in the United States.
“Evolution” of the biosimilar marketplace is the key word. Since the implementation of the Biologics Price, Innovation, and Competition Act in 2010, the regulatory policies of the US Food and Drug Administration, the relationship of the commercial and public insurers with biosimilars and their innovator or reference products, and the future of biosimilar development has been in flux. This includes:
- The clinical trial requirements for biosimilar candidates
- Biosimilar naming conventions
- Exclusivity periods
- The nature of interchangeability (or even the necessity of it)
- FDA review timelines
- Patent litigation and settlements
- Pharmacy benefit managers serving as private-label biosimilar manufacturers
- Employers awakening to the value of biosimilars
All of these major themes have evolved and shaped how the US healthcare system views, utilizes, and covers biosimilar agents in the oncology, autoimmune, diabetes, and ophthalmology spaces to date.
The regulation, marketing, and clinical testing of agents that are biosimilar to “innovator” or “reference” products has been extremely unsettled. BR&R provides education, commentary, and updates on the biosimilar marketplace. Our coverage of biosimilar news includes:
- Biosimilar drug research and clinical trial development
- Biosimilar blogs, biosimilar posts, and other commentary
- FDA approvals
- Regulatory issues
- Biosimilar news on financing, meeting highlights, and 351(k) applications
- Contracting/rebating/pricing
- Product launches
- Tracking of biosimilar utilization
