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Brief of Amicus Curiae Biotechnology Innovation Organization in Support of Plaintiffs-Appellees in Amgen Inc. v. Apotex Inc. (U.S. Court of Appeals for the Federal Circuit)

Brief of Amicus Curiae Biotechnology Innovation Organization in Support of Plaintiffs-Appellees in Amgen Inc. v. Apotex Inc. (U.S. Court of Appeals for the Federal Circuit)

INTEREST OF AMICUS CURIAE
 
The Biotechnology Innovation Organization (“BIO”) is the world’s largest
biotechnology trade organization, representing more than 1,000 member
companies and research organizations—from startups to Fortune 500 companies—
who research and develop biotechnological products including lifesaving
medicines. Biological medicines are now used to treat previously untreatable
diseases and have prolonged and improved the lives of countless patients. But,
development of a biological medicine generally requires a decade or more of
research, as well as a fully capitalized investment that on average exceeds
$2 billion.
 
BIO played a leading role in the effort to establish a statutory pathway for
abbreviated approval of biosimilars that would lower costs through increased
competition and expand access to lifesaving medicines while protecting patient
safety and promoting further biomedical innovation. The aptly named Biologics
Price Competition and Innovation Act (“BPCIA” or “the Act”) aims to achieve those goals.
Many of BIO’s members are global leaders in the development and
commercialization of both innovative biologics and biosimilars. Accordingly, BIO
and its members have a strong interest in the proper interpretation of the critical
provision of the BPCIA at issue in this case.