Safe Biologics

On May 10th, ASBM cohosted an educational briefing on biosimilars with the Ohio State University College of Medicine at the University’s Wexner Medical Center in Columbus, OH. The audience was comprised of a broad cross section of stakeholders including patient advocates, physicians, pharmacists, representatives from the Ohio Pharmacy Association, The Ohio Nurses Association,  a State Representative, medical and pharmacy students and others.

The program began with an introduction by Dr. Robert Weber, Administrator of Pharmacy Services at Wexner Medical Center and Assistant Dean of the OSU College of Pharmacy, who introduced ASBM’s Advisory Board Chair, Dr. Philip Schneider. Dr. Schneider, currently Associate Dean at the University of Arizona’s College of Pharmacy, had served on the OSU faculty for 33 years and led the Pharmacy Residence program at the Wexner Medical Center.

Dr. Schneider began his presentation with an overview of the basic science of biologic medicines, their differences from small-molecule chemical drugs in terms of their production, size, complexity, and sensitivity to manufacturing changes and environmental conditions. Biosimilars, he explained, should not be thought of as generic biologics; rather as new biologics that are “highly similar” to the biologic whose therapeutic properties they attempt to duplicate.

He then explained how biosimilars require a different regulatory approach, citing several key issues facing policymakers.

For example, clear product identification is critical when dealing with two similar biologic medicines. Distinct naming of biologics aids in long-term tracking of their safety and efficacy and allows accurate attribution of any adverse events to the correct product. Dr. Schneider discussed the FDA’s proposed naming system and his work with the World Health Organization, which is crafting international naming standards for biologics.

Distinct naming, he noted is widely supported by healthcare providers, with 68% of pharmacists and and 66% of biologic prescribers supporting the FDA issuing distinct names for all biologics, including biosimilars. While the FDA has used differentiating suffixes based on the manufacture name in its biosimilar approvals, it has also used random suffixes. Dr. Schneider emphasized that ASBM’s survey data showed a clear preference for meaningful suffixes, with 60% of prescribers and 77% of pharmacists favoring meaningful, manufacturer-based suffixes, which are more memorable for healthcare providers.

Regarding the labeling of biosimilars, Dr. Schneider noted that providers want more transparency than is currently required by FDA’s Draft Guidance on labeling. For example, 80% of prescribers and 76% of pharmacists consider it important or very important that a biosimilar’s label state whether approval was granted for an indication based on study in that indication, or on extrapolation from study in a different disease.

Finally, Dr. Schneider turned to the subject of pharmacy substitution of biosimilars, discussing how many U.S. states are addressing what communication must occur between providers when a biosimilar is substituted. Only biosimilars deemed “interchangeable” by the FDA (producing the same effects as the reference product without additional risks if switched from the reference) could potentially be substituted without physician involvement. Yet 20 states require a pharmacist to communicate which biologic – the originator or the biosimilar- was dispensed, so that the physician and patient can maintain an accurate patient record and continue to make informed treatment decisions. Such communication is considered “very important” or “critical” by 80% of U.S. prescribers, with similar numbers found among prescribers in all eleven countries ASBM has surveyed. Under the state legislation, prescribing physician would still be able to block a substitution by designating “dispense as written” (DAW). DAW authority is considered “very important” or “critical” by biologic prescribers worldwide, including 82% of U.S. prescribers.

View Dr. Schneider’s presentation here.

Following Dr. Schneider’s presentation, patient advocate Andrew Spiegel, Executive Director of the Global Colon Cancer Association provided a patient’s perspective. He discussed the benefits of biologic medicines for patients, and the great promise of biosimilars in expanding access to biologic treatments through cost savings and new therapeutic choices. But, he cautioned, it was important that the ultimate treatment decisions should remain between physician and patient, rather than being made by a third party such as an insurance company for non-medical reasons such as potential cost savings or profit.

Mr. Spiegel also emphasized that confidence in biosimilars is key to their success, citing clear naming and transparent, informative labeling as key elements in building patient confidence in biosimilars.

View Mr. Spiegel’s presentation here. 
Next, Judy Nagy, a rheumatoid arthritis patient, spoke about her struggles in managing her disease and the importance of education on biologic medicines. Ms. Nagy, who is part of ASBM member Global Healthy Living Foundation‘s 50-state patient network,  emphasized that patients need physicians, pharmacists, manufacturers and policymakers to work together to craft sound, patient-centered policies on biosimilars that expand access but do not compromise safety.

Finally, a robust Q & A portion followed, in which the panel answered questions from healthcare providers, as well as medical and pharmacy students.

Representative Stephen A. Huffman, who is sponsoring a biosimilar substitution bill in Ohio, was in attendance and answered audience questions about the bill.

View the entire program here: