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Biosimilars Now Just About Ready to Roll

By Vincent Capuano and Anthony Fitzpatrick
September 1, 2012
Genetic Engineering & Biotechnology News

Following the U.S. Supreme Court's decision to leave intact the Patent Protection and Affordable Care Act, the development of biosimilars to treat a wide variety of diseases and health conditions is poised to surge. The Act contains important provisions that create a pathway for the FDA to approve "biosimilar" versions of previously approved biotechnology drugs.

The Act created an abbreviated licensure pathway for biological products in the part of the law known as the Biologics Price Competition and Innovation Act. Under the BPCI Act, a biological product may be demonstrated to be "biosimilar" if data shows that, among other things, the product is "highly similar" to an already approved biological product.

To read the entirety of the article, please visit the Genetic Engineering & Biotechnology News website.

Vincent Capuano and Anthony Fitzpatrick are partners in the Intellectual Property Practice Group in the firm's Boston office.