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NCCN Oncology Policy Summit: Biosimilars - Regulatory, Scientific, and Patient Safety Perspectives

By Jessica DeMartino, PhD, Manager Health Policy Programs

The use of biologics is widespread in the active treatment of cancer and for supportive care management. As the use of biologics continues to grow and older biologics come off patent, consideration will need to be given to the incorporation of biosimilars into clinical practice and the safety and outcomes of patients with cancer. As the Food and Drug Administration (FDA) implements elements of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), stakeholders must actively engage in discussions to ensure biosimilars are safe and effective for the treatment of patients with cancer.

The policy issues surrounding biosimilars have come to the forefront of discussion because of their potential to reduce health care costs (based on an extrapolation of the cost benefits from generic small-molecule drugs). However, there are significant scientific and manufacturing challenges to ensuring that a biosimilar is equivalent to the innovator product. Additionally, the FDA has not yet developed a robust biosimilar approval pathway, raising questions regarding the types of studies (pre-clinical and clinical) that would be required to gain FDA approval. Furthermore, biosimilars exude safety concerns related to immunogenicity. Coupling these concerns with a skepticism regarding whether or not there is equivalent efficacy compared to the reference product, clinicians may be hesitant to utilize biosimilars. Potentially, a low uptake of biosimilars and a heavy investment in biosimilar development may minimize the cost benefit derived from a lower acquisition price of biosimilars.

On April 29, 2011, NCCN will host an invitation-only NCCN Oncology Policy Summit: Biosimilars – Regulatory, Scientific, and Patient Safety Perspectives to provide a forum for in-depth discussion of the aforementioned regulatory, safety, and clinical issues surrounding biosimilars. On March 12, 2011, NCCN convened a multidisciplinary, diverse Work Group that identified challenges and provided recommendations on the topic of biosimilars in oncology. The focus of the Policy Summit will be on illuminating these challenges and offering recommendations, from a multi-stakeholder viewpoint, for the best strategies to overcome these challenges.

 

 

 

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