6 Recommendations as FDA Considers New Biosimilar Approvals
By Larry LaMotte
Patient communities are eager for new and affordable treatment options, especially those that can treat serious, life-threatening diseases. Biologic drugs have expanded treatment options for patients and offered many patients effective therapies for the first time in their lives. Biosimilars, a new class of drug, have the potential to further expand access.
But with the potential of new biosimilar treatments also comes potential risks, including immunogenicity — or an immune response that can lead to severe allergic reaction and potentially cause patients to no longer respond to therapy — and the lack of long-term safety data.
The FDA has two advisory committee meetings in July where they will consider new biosimilar drugs for approval. PBSA has six specific comments, concerns and recommendations for action that apply to any situation where the FDA is considering biosimilars, which we outlined in a letter to FDA Commissioner Robert Califf earlier this year:
1) Promote transparency and patient safety in biosimilar labeling.
2) Take precautions to prevent multiple switches without adequate safety testing.
3) Assure that the FDA have clear review standards and processes to protect patients and ensure efficacy of biosimilars prior to making decisions on applications.
4) Get Advisory Committee Guidance on Extrapolated Indications.
5) Focus on safety, not costs.
6) Provide adequate time to review materials.
Below is the full text of our letter to FDA Commissioner Robert Califf:
LaMotte is the vice president for Public Policy at the Immune Deficiency Foundation (IDF), a national non-profit patient organization dedicated to improving the lives of patients with primary care immunodeficiency diseases. Patients for Biologics Safety & Access (PBSA) is a national coalition representing more than 20 patient advocacy organizations working to ensure that the voices and interests of patients are heard as the FDA considers approval of a new category of drugs known as biosimilars.