Table of Contents
The route to a formal US regulatory pathway for biosimilar approval was established with the creation of the Biologics Price Competition and Innovation Act of 2010. However, it has taken five more years for the first biosimilar to be launched in the US through this pathway. Despite the presence of this regulatory pathway a number of regulatory uncertainties exist that require clarification in order for the US biosimilars market to be fully realized. These uncertainties include the naming of biosimilars, as well as questions on labeling, substitution, and interchangeability. In addition to the regulatory questions there are also a number of legal issues that are yet to be resolved and which may have a significant impact on the future approval and launch of biosimilars in the US.
Once these regulatory and legal hurdles are overcome, it is anticipated that there will be few, if any, major obstacles to market access, with access expected to be relatively straightforward due to the cost benefits that biosimilars offer. Physician reluctance to use biosimilars interchangeably with the original product may prove to be an issue, albeit one that can be overcome with education efforts.
This report addresses the following questions:
- What are the regulatory approval requirements in the US and how do they differ from Europe?
- What are the current biosimilars naming and substitution rules and how will they impact access to biosimilars?
- What precedents have been set by ongoing legal dispute and how will they impact the timing of market entry of biosimilars?
- How do payers view biosimilars and what measures do they intend to use to stimulate biosimilars uptake?
- Which stakeholders to biosimilars and branded biologics manufacturers need to target in their biosimilars education efforts and with what information?
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