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by Amanda Conschafter, blog editor


The Food and Drug Administration’s role is to determine a follow-on drug’s biosimilarity to its biologic predecessor, explained FDA’s Steven Kozlowski, MD, at Tuesday’s National Policy & Advocacy Summit on Biologics and Biosimilars. But biosimilarity data alone may not be enough to satisfy patient safety demands – or to instill confidence in prescribers. Speakers during the day-long event emphasized the need for naming, labeling and approval processes that give physicians enough information to gauge a biosimilar’s suitability for a patient – and to monitor that patient’s response.

Patient Safety and Prescriber Confidence

In a morning policy panel, HPS Group’s Steven Grossman reiterated the fact that biosimilars are different than traditional generics. Panelists agreed on the importance of distinct names for biosimilars and the need for prescriber communication when pharmacists substitute a biologic for a biosimilar. Patient advocate Barbara Biehler emphasized the importance of a physician knowing exactly which medication his or her patient was taking. David Charles, MD, described the importance of “dispense as written” to making sure that physicians and patients – not health plans – control a patient’s course of care.


On the topic of indication extrapolation, the Arthritis Foundation’s Anna Hyde noted the challenges of requiring FDA advisory committee members to take “an up or down vote” rather than allowing members to vote on each indication. Dr. Charles highlighted the potential risks of extrapolating approved uses, asking, “How do I tell my patient that I’m prescribing them a drug that has never been tested for their disease?”

Dennis Cryer, MD, of the Biologics Prescribers Collaborative echoed the need for patient-centered policies, as did Larry LaMotte from Patients for Biologics Safety and Access. Dr. Cryer introduced The Biosimilar Promise, a new handbook from the Biologics Prescribers Collaborative.

Representative Brad Wenstrup (R-Ohio) of the House Doctors Caucus IMG_9245-2addressed the group on the importance of policy that was informed by – and useful for – health care providers. Rep. Wenstrup emphasized the importance of the physician-patient relationship and acknowledged the value of innovative medicines such as biologics.

Cost and Value

A secondary theme of the summit was the challenge posed by rising drug costs and related coverage problems. Brian Kennedy introduced the Alliance for Patient Access’ new policy proposal, “Informed Drug Pricing,” which advocates for incorporating patient advocates and health care providers in pricing and health plan coverage decisions. An afternoon panel explored the ideas in AfPA’s policy proposal and examined pricing from the perspectives of industry, health care providers and patient advocates. Panelists included Pfizer’s Robert Popovian, neurologist and AfPA member Robert Yapundich, MD, and the National Psoriasis Foundation’s Quardricos Driskell. Damian Garde of STAT served as moderator.


The event’s celebrity keynote speaker was Jerry Mathers, childhood star of television’s iconic “Leave it to Beaver.” Mathers described his experience with psoriasis, a condition commonly treated by biologic medicine.


Additional Resources

For related materials, see:

Social media coverage of #AfPASummit.

Informed Drug Pricing: A Patient-Centered Approach to Protecting Access to Advanced Medicines

The Biosimilar Promise

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