The FDA recently requested comment on its draft guidance for implementation of the “deemed to be a license” provision as described in section 7002(e) of the Biologics Price Competition and Innovation Act of 2009 (“BPCI Act”). Section 7002(e) addresses the circumstances under which an application filed under section 505 of…
The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…
As we previously reported, negotiations on the Trans-Pacific Partnership Agreement, for which President Obama has been given fast-track authority to negotiate, are well underway, and leaders have been meeting this week in Maui to iron out what many believe will be the final deal. One of the most contentious issues…
On May 21, 2015, the Energy and Commerce Committee voted unanimously to advance the 21st Century Cures Act, which the Committee has presented as “a bill to help modernize and personalize health care, encourage greater innovation, support research, and streamline the system.” The legislative text of the proposed bill spans…
Below we provide a short introduction to the world of biologics and the BPCIA. For a more comprehensive guide on biosimilars, check out Goodwin Procter’s Biosimilars: A Guide to Regulatory and Intellectual Property Issues. What are biologics? Biologics are medical products such as vaccines, therapeutic proteins, and gene therapies that…