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FDA Issues Final Guidances on Biosimilarity Demonstrations, Exclusivity Determinations and Other BPCIA Issues
Practical Law Legal Update 6-610-9406 (Approx. 3 pages)
FDA Issues Final Guidances on Biosimilarity Demonstrations, Exclusivity Determinations and Other BPCIA Issues
by Practical Law Intellectual Property & Technology
| Published on 29 Apr 2015 • USA (National/Federal) |
The US Food and Drug Administration (FDA) issued final industry guidances that describe the agency's current views concerning implementation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), including biosimilarity demonstrations and exclusivity determinations.
On April 28, 2015, the US Food and Drug Administration (FDA) issued a series of final guidance documents that describe the agency's current views on and implementation strategy for the Biologics Price Competition and Innovation Act of 2009 (BPCIA) (42 U.S.C. § 262). The guidances include:
- Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product and Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, which describe the FDA's current thinking concerning how to demonstrate biosimilarity. For more information on biosimilarity, see Article, Expert Q&A on Biosimilar Patent Litigation under the BPCIA.
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, which provides common answers to frequent questions from sponsors interested in developing proposed biosimilar products, biologics license application holders and other interested parties regarding the FDA’s interpretation of the BPCIA.
The FDA noted that while the documents are not binding and do not create legally enforceable responsibilities, the guidance should be viewed as the agency's recommendations.