Biosimilar Briefings Review Nature and Impact of Biosimilars on Access

In a series of briefings that began in Sao Paulo, Brazil and Buenos Aires, Argentina, clinicians who practice rheumatology, dermatology and oncology are getting up to speed on the science and policy behind these medications, which are follow-on versions of original biologic drugs.

The briefings served as an opportunity for clinicians and key opinion leaders from the country to dive deeper into the nature of biosimilars, and some of the benefits and scientific based policy principles on their safe use. Organized by the Global Alliance for Patient Access and the Biologics Prescribers Collaborative, the briefings featured two expert physicians in the field of biologics and biosimilars: David Charles, MD, chair of the Alliance for Patient Access, and Arturo Loaiza-Bonilla, MD, chair of the Global Alliance for Patient Access. Both are physician co-conveners for the Biologics Prescribers Collaborative.

Topics included:

• Quality: Physicians want to be sure they are treating patients with high quality biosimilars, meaning that there are quality control measures in place, there is a reliability in the supply and high-quality manufacturing.
•  Pharmacovigilance: The system used in detecting, tracking, analyzing, and preventing negative side affects and adverse reactions to drugs.
• Indication Extrapolation: The approval of a biosimilar for conditions for which it has not been studied, based on its similarity to the innovator biologic. In order to err on the side of patient safety, the extent of evidence required for a biosimilar to be granted indication extrapolation should be considered carefully and, on a case-by-case basis.
• Switching: The treating physician switches one medicine for another with the same therapeutic intent in patients who are undergoing treatment. This can happen as a result of physician’s choice, or may be dictated by a hospital, insurance company, or government policy.
• Naming: To accurately prescribe and monitor the effects of a biologic or biosimilar, physicians need nonproprietary names that distinguish between the innovator product and the biosimilar. Distinct naming helps to protect patients by facilitating substitution notification, safety monitoring, accurate adverse event reporting, and traceability.
• Current regulatory policies and pathways that exist both in Europe (with regards to the EMA) and the US (with regards to the FDA).

The physicians discussed the six keys to advocacy and broke down the ways in which the attendees could become effective advocates for the patients they treat. These methods could then be used by the attendees as they maneuver the regulatory and political landscape involved with access to approved treatments.

GAfPA and the Biologics Prescribers Collaborative will also host biosimilar briefings in Colombia, the UAE and Turkey this year.