SAN DIEGO, CA- On May 28, 2015 a panel discussion was held that examined the perspectives of innovator companies, biosimilar manufacturers, biotechnology reporters, and the health provider community on the topic of biosimilar development and marketing. The panel was held in as part of the World Biosimilar Congress 2015.
ASBM chairman Dr.Harry Gewanter provided the physician/patient perspective. Alex Waldron, VP of Global Commercial Operations for biosimilar manufacturer Epirus Pharmaceuticals; and Rakesh Dixit, VP of Research & Development and Global Head of Biologics Safety Assessment for innovator biologic company MedImmune, provided the perspectives of their industries. The panel was moderated by Bloomberg analysts Elizabeth Krutoholow and Aude Gerspacher, who released the results of a Bloomberg survey. The Bloomberg survey asked many diverse stakeholders in the biosimilars discussion about trends in the biosimilars market. Among the survey’s findings:
- Respondents overwhelmingly agreed that the most important guidance issued by FDA would be that regarding Interchangeability.
- 55% of respondents expected that biosimilars will have the same INN as their reference product with a batch number of biological qualifier.
- When asked to estimate potential savings from biosimilars relative to innovator products, this was estimated to be in the 20%-40% range by the majority (71%) of respondents.
During the panel discussion, Dr. Gewanter presented the physician perspective– that transparency/clarity in naming and for purposes of identification and pharmacovigilance was an essential component of patient safety that should trump cost considerations- which was largely echoed by Rakesh Dixit of MedImmune, while Mr. Waldron of Epirus Pharmaceuticals challenged this view, suggesting that potential safety risks to patients need to be balanced against the potential benefits of increased access and potential savings to payers.
Dr. Gewanter’s presentation on physician perspectives was well received by the audience, which numbered around 70 attendees. Dr. Dixit asked Dr. Gewanter if major biotech companies possessed a competitive advantage in biosimilar production, to which Dr. Gewanter posed the analogy of VIZIO brand televisions- a new market entrant with a discount price point which needed to prove its quality to consumers relative to more established, familiar, and trusted brands. When asked by an audience member why the U.S. should not simply copy the European approach, Dr. Gewanter replied that there were lessons to be learned from Europe’s mistakes as well as their successes, and that more data and transparency, particularly in naming and labeling was needed to build physician confidence. In addition to making a strong case for distinguishable naming, Dr. Gewanter spent several minutes on the subject of labeling, highlighting physician concerns with the lack of labeling transparency regarding Zarxio.
In a separate presentation, pharmacist Doug Monroe (Project Manager for Biotechnology, Emerging Technology, and Specialty Pharmacy for Kaiser Permanente) provided a payer perspective. Dr. Monroe emphasized the process taken by the Pharmacy and Therapeutics (P&T) Committees within his company, which he described as being based upon a totality of scientific evidence from varied sources such as the FDA, the biosimilar sponsor, published reports from journals, and the European biosimilars experience.
Despite their varied perspectives, all the participants agreed on one matter: that building physician confidence in biosimilars was critical to their successful adoption.
