Pfizer Colleagues Engage Congress on Follow-on-Biologics
May 2009

Pfizer is committed to legislation that creates an open, transparent and science-based regulatory process for approving biosimilars. Congress is considering several bills that would establish a regulatory pathway for the approval of follow-on-biologics. One bill, H.R. 1548, the Pathways for Biosimilars Act, would create a solid framework for the approval of follow-on biologics while at the same time taking steps to ensure patient safety and promote research and innovation.

This bill, introduced by Representatives Ann Eshoo (D-CA), Joe Barton (R-TX) and Jay Inslee (D-WA), fosters continued innovation through an appropriate period of data exclusivity and robust patent protection. Pfizer colleagues have been actively reaching out to their representatives in Washington to discuss the merits of this bill and ask legislators for their support.

Biologics are made from living matter and are far more complex than small molecule drugs. As a result, making a biosimilar product is a much more difficult task than making a generic drug; no two biologic products are the same. Biosimilars are not copies of the original biologic product. Subtle differences in structure between two different biologics can have a significant impact on their safety and therapeutic effect that can only be verified through clinical trials. Fortunately for patient safety and health, H.R.1548 includes provisions requiring these assurances.

H.R.1548 includes an appropriate period of data exclusivity for biologics. Patents, in the context of biosimilars, do not provide the same protections or certainty for biologics that they do for small molecule drugs – it’s actually possible for developers of biosimilars to try to work around patents on the original biologic. A significant period of data exclusivity – in line with what is allocated in H.R. 1548, will assure that developers of new biologics have the certainty necessary for researchers to continue developing life-saving new medicines.

Throughout April, colleagues have worked with our Washington, DC office on engaging members of Congress in support of this bill. Congressional District Captains – colleagues who take an active role in building relationships with their Member of Congress – arranged meetings to discuss this issue in targeted districts across the country. In addition, a national mobilization was launched where we asked colleagues to write their members of Congress, with a remarkable result. To date, over 2,500 letters have been written to Congress from Pfizer colleagues – all done within just a few short days.

We will continue to engage Congress on this important issue. We also encourage you to call your Member of Congress and ask for their support of H.R. 1548.

If you would like more information about this issue or to learn how you can be an advocate on important issues that affect you, your family and Pfizer, contact pfizerinaction@pfizer.com or sign up to Become an Advocate.