BIO Testifies on Importance of Data Exclusivity and Patent Protection in Pathway for Approval of Biosimilars

The Biotechnology Industry Organization (BIO) appreciates the opportunity to provide the views of its members on intellectual property issues implicated by an abbreviated regulatory procedure for the approval of highly similar biological products, or so-called “biosimilars.”

BIO supports the creation of an abbreviated pathway for biosimilars to help increase competition among, and access to, the many breakthrough biomedical advancements that have been developed by the biotechnology industry over the past 25 years. In doing so, providing effective intellectual property protection for biological products must remain a central focus of Congressional efforts. Measures that operate to lessen the economic incentives of our current system will translate into fewer new biological products and therapies, to the detriment of patients with currently unmet medical needs.