Biologics Prescribers Collaborative Calls on FDA to Address Interchangeability, Suffixes

In regard to the naming guidance for biosimilars that states that each product must be given a random 4-letter suffix that is devoid of meaning, the organization encourages the FDA to reconsider.
Samantha DiGrande
August 25, 2018
Since the release of the Biosimilar Action Plan (BAP) last month, many industry stakeholders have offered their thoughts on the efforts outlined in the plan. Response to the release of the plan as well as strategies to spur biosimilar uptake have been largely positive, though some groups offered advice on how best to achieve this goal.

Recently, the Biologics Prescribers Collaborative (BPC) offered its take on the plan, noting that, as an organization, it “advocates for policies that promote development and approval of biosimilar medicines while maintaining the highest standards of safety and efficacy.”

The BPC supports the FDA in actions to prioritize effective communication with prescribers, patients, and payers, and continue educational efforts on biosimilars for these groups. Additionally, the BPC also encourages the FDA’s plan to develop application review templates that will not only improve the efficiency of biosimilar and interchangeable development and approval, but also enhance public information around this process.

While part of the FDA’s efforts include updating its guidance on interchangeability, the BPC had a note of caution against any modified rules that may lower the standards for interchangeability. “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,” its comments noted.

The BPC also recommends that manufacturers be required to perform studies to determine whether alternating between a reference product and a proposed interchangeable biosimilar multiple times impacts the safety or efficacy of the drug.

In regard to the naming guidance for biosimilars that states that each product must be given a random 4-letter suffix that is devoid of meaning, the BPC encourages the FDA to reconsider, stating that instead, the suffix should be memorable.

Overall, however, the BPC was supportive of the FDA’s efforts to generate more biosimilar uptake, and applauded the FDA for listening to its stakeholders and working to optimize the regulatory framework.

“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 new important class of medicines,” read the comments.
 

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