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Physicians and patients are no longer asking if a biological medicine is the best choice, but – more likely – which biological medicine is the best choice.  This opening thought from Alliance for Patient Access Chairman David Charles, MD, set the tone for the organization’s second annual National Policy and Advocacy Summit on Biologics and Biosimilars, held Thursday in Washington, DC.

Patients, government representatives, physicians and advocates explored throughout the day-long event how more biological options present both new challenges and new possibilities for treatment.  The event was co-sponsored by the Institute for Patient Access and the Biologics Prescribers Collaborative.

Policy & Advocacy Issues

The summit’s policy discussion spanned both global and U.S. issues.

Global Issues

An international panel examined Europe and Latin America’s experiences with biologics and biosimilars, including what lessons they might offer the United States.




Panelists pointed to work by the Global Alliance for Patient Access to illustrate how coordinated advocacy is encouraging informed policymaking on the international stage.

U.S. Issues

Questions of switching resurfaced in the “Policy Advocacy in the States” panel, which also examined the problems associated with step therapy:



Moderator Brian Kennedy used a new video from the Keep My Rx campaign to highlight state efforts to protect patients from non-medical switching.

In a morning address to summit attendees, Sen. Bill Cassidy, MD, (R-La.) provided a federal legislator’s viewpoint on breakthrough drugs’ value.  A patient who benefits from a life-changing therapy such as a biologic is “working, living life, paying taxes, and not in the hospital,” Sen. Cassidy explained, adding that “If there’s a breakthrough therapy, it needs to be quickly approved.”


Sen. Cassidy emphasized that policymakers must determine how to advance access to breakthrough medicine “without bankrupting the country.” He argued, however, that price controls would have the opposite effect, chilling investment and hindering innovation for conditions such as Alzheimer’s.

Food and Drug Administration Guidance

Recent FDA guidance on biosimilar naming and draft guidance on interchangeability made regulatory issues a central topic for the summit.  The latter is the subject of a new Alliance for Patient Access video, unveiled Thursday morning.

The FDA’s Leah Christl, PhD, elaborated on interchangeability guidance, explaining that the agency would build upon its totality of evidence approach.  She also noted that the agency may require post market data for therapies whose impact leaves “residual uncertainty.”

An afternoon panel invited further discussion on regulatory issues.  Hosted by Inside Health PolicyAssociate Editor Nicholas Florko, panelists considered biosimilar labeling, the impact of distinct naming and what interchangeable biosimilars might mean for patients and policy.



Patient Impact

Olympic medalist and cancer survivor Shannon Miller gave the event’s keynote address, a testimony to the power of the physician-patient relationship and how breakthrough medicine saves patients’ lives.


Though best known as a seven-time Olympic gold medalist and member of the United States’ 1996 “Magnificent Seven” gymnastics team, Miller is now a women’s health advocate.  In describing her battle with ovarian cancer, Miller encouraged patients, “Keep fighting and take advantage of new, breakthrough therapies!”

The day ended with remarks from AfPA Executive Director Brian Kennedy.

For related materials, see:

Social media: Coverage of #BiologicsSummit
Video: The Interchangeability Promise
Video: Understanding Non-Medical Switching

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