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Abstract

The Biologics Price Competition and Innovation Act of 2009 provides an abbreviated FDA approval pathway for biosimilars. The passage of this biosimilar legislation is a positive step toward retaining a robust biotechnology industry in the United States while also protecting innovators. The Act’s increased FDA exclusivity is welcome, but FDA exclusivity alone is insufficient to encourage and protect innovation and investment in biosimilars. Instead, the exclusivity provided by a patent term, together with the ability to adjust this term to compensate an applicant for U.S. Patent and Trademark Office and FDA delays, is necessary to ensure development of highly specialized andresource-intensive biologics. This article suggests a closer correlation of the patent term with FDAmarket approval. The author argues that while it may be difficult to strike a perfect balance, all willbenefit when innovator biologics have strong patent protection coupled with long FDA exclusivityperiods.