The Biologics Prescribers Collaborative (BPC) appreciates the U.S. Food and Drug Administration’s (FDA) release of its Biosimilars Action Plan (BAP) on July 18 as an important step towards realizing the promise of biosimilars by expanding patient access to these lifesaving therapies. As a coalition of organizations whose membership is comprised of specialists who prescribe biologic medicines, BPC advocates for policies that promote development and approval of biosimilar medicines while maintaining the highest standards of safety and efficacy.
Guided by our organization’s mission to protect patient safety and build confidence among physicians in this new class of medicines, BPC is pleased that the FDA continues to take a thorough approach to encouraging innovation and competition among biologics and the development of biosimilars. With a dozen biosimilars now approved in the U.S., and as the FDA works to finalize several important guidances to make the regulatory pathway as clear and efficient as possible for manufacturers, BPC urges the FDA to maintain appropriate, science-based regulatory standards it has worked very hard to design following the passage of the Biologics Price Competition and Innovation Act (BPCIA) in 2010.
As a coalition of organizations representing physicians who regularly prescribe biologics, BPC has a unique and important perspective about these issues and would like to respond to several components of the FDA’s plan:
- Throughout the BAP, the FDA emphases that it is prioritizing effective communication with prescribers, patients and payers. BPC appreciates the FDA’s efforts to educate these key audiences about biosimilars and interchangeable products and build on the momentum from the Agency’s Biosimilar Education and Outreach Campaign through the development of new resources that will help explain important concepts related to biosimilars. This approach closely aligns with BPC’s stance that education is key to helping prescribers make informed decisions about biosimilars and build confidence in their use, and BPC looks forward to supporting the FDA in these educational efforts and to continuing to produce helpful resources like our Biosimilar Promise Handbook.
- The FDA is also seeking to improve the efficiency of the biosimilar and interchangeable product development and approval process as a part of the BAP. For example, the FDA plans to develop application review templates that will not only streamline the process but enhance public information about the FDA’s evaluation of biosimilar and interchangeable products. BPC fully supports these efforts, as it means more information for prescribers and patients to demystify and expand understanding of the rigorous process of evaluation for biosimilars.
- As the FDA is planning to increase focus on the rapid development of additional guidance to provide further clarification of the regulatory pathway for biosimilars, BPC, like the American Medical Association in its recently recommended HOD resolution 523 (see p. 23), encourages the FDA to finalize the 2017 draft interchangeability guidance as soon as possible. To further the development and designation of interchangeable biosimilar products and ensure the rigorous nature of these standards, BPC believes data required to demonstrate interchangeability should be robust and risk-based, and that manufacturers be required to perform studies to determine whether alternating between a reference product and the proposed interchangeable biosimilar multiple times impacts the safety or efficacy of the drug. BPC cautions against any modified rules that may lower the standards for interchangeability and thus increase the number of biosimilars that can be automatically substituted without robust clinical evidence to support this practice. This has the potential not only to lower physician confidence in biosimilars, but to alter the risk and benefit for patients after switches as it is not known which structural differences in the products might lead to an increased risk of immunogenicity.
BPC appreciates the FDA’s careful consideration of these and other important issues related to biosimilar and biologic medicines, and are eager to maintain an open dialogue with the FDA and other stakeholders to ensure that final guidances and outputs of the BAP are aligned with our core objectives aimed at strengthening confidence in biosimilars. BPC continues to advocate for the following:
- Finalized interchangeability guidance;
- Distinguishable non-proprietary names for biological products, including previously approved originator drugs;
- BPC supports the FDA’s goal to facilitate pharmacovigilance and prevent inadvertent substitution through the use of distinguishable suffixes, however BPC encourages the FDA to consider that the suffix should be memorable, which is not routinely achieved with a random suffix.
- Careful considerations around non-medical switching, which undermines the patient-physician relationship and could allow treatment decisions to be made that are not based on medical need;
- Clear and thorough labeling for biosimilar products such that they contain all needed data for physicians to make appropriate prescribing decisions for their patients;
- BPC supports the FDA’s final guidance on labeling for interchangeable products, issued in July 2018. Specifically, BPC applauds FDA for including in the guidance the requirement that labels accurately reflect scientific evidence; that any statements in the scope indication comparing the safety or effectiveness of drug or biological products with other agents for the same indications must be similarly supported (i.e., by substantial evidence of effectiveness); and that the indication include the product’s proprietary name (or trade name) or nonproprietary name if the product does not have a proprietary name.
- Case-by-case extrapolation determinations based on extensive analytic and clinical data; and
- Unique J-Codes for each biosimilar product (unless deemed by the FDA to be “interchangeable” with the reference biologic).
BPC looks forward to continued engagement with the FDA to support the implementation of the BAP in a way that fosters physician understanding, confidence, and uptake in this important new class of medicines. As an organization of prescribers, BPC applauds the FDA for listening to its stakeholders and working thoroughly to optimize the regulatory framework and ultimately increase education and access to biosimilars.
About the Biologics Prescribers Collaborative (BPC)
The Biologics Prescribers Collaborative (BPC) is a coalition of professional organizations which represents physicians who regularly prescribe biologics. BPC strives to ensure that sound policies are in place to promote the safest possible development and use of all biologics, including biosimilars, for all patients.