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Updated Legal and Regulatory Frameworks Needed for Biosimilars

January 8, 2015
Biosimilars raise novel and complex questions of science and law that require updated legal and regulatory frameworks.

We call on the FDA to release final guidance on processes and scientific criteria for the approval of biosimilars, outline its approach to naming and labeling, and clarify its conditions for determining a biosimilar to be interchangeable with its reference biological.

There has been positive momentum recently, however, we believe the appropriate way to develop policy on such a significant new approval pathway is through published guidance documents with the opportunity for public comment, rather than through single-application advisory committee meetings.

Together with our member companies, we supported and worked for the enactment of the Biologics Price Competition and Innovation Act (BPCIA) because its provisions help to balance the desire to provide greater choice for patients and physicians through market entry of safe and effective biosimilars with the need to preserve incentives for the innovation of new biologics that not only save and improve lives but also provide the blueprint for future biosimilar products.

For more than a decade, we have called for open, transparent, and science-based dialogue regarding biosimilars and we played a leading role in the effort to establish a pathway for the approval of biosimilars. There are fundamental scientific considerations at the heart of the debate regarding biosimilars, and we welcome and encourage a dialogue among all stakeholders as there are important implications for the appropriate use of all biologics, whether innovative or biosimilar.

We are committed to preventing any legislative erosion of the BPCIA, and we will continue to advocate for appropriate implementation at FDA and CMS to ensure that these agencies’ regulatory and reimbursement decisions protect and benefit patients and encourage incentives for innovation.

Our key principles for biosimilars include ensuring patient safety, recognizing scientific differences between drugs and biologics, maintaining the physician-patient relationship, and preserving incentives for innovation.