Dr. Lyman on Challenges with Biosimilar Policies

Gary H. Lyman, MD, MPH, senior lead, Health Care Quality and Policy, Hutchinson Institute for Cancer Outcomes Research, member, Cancer Prevention Program, Public Health Services Division, and member, Clinical Research Division, Fred Hutchinson Cancer Research Center, discusses challenges in biosimilar policies.

There is skepticism surrounding biosimilars and the depth of impact they will have on the rising cost of cancer care in the United States, explains Lyman. While biosimilars will help the high cost of healthcare, changes at the policy are also necessary. At the policy level, there is hesitancy among professional organizations because they want to see data and evidence, says Lyman. If there is an Oncology Drug Advisory Committee meeting, all of that information is transparent and made available; however, the more recent biosimilars have been approved without public disclosure. Lyman recommends companies publish their preclinical and clinical data in peer-reviewed literature.

Lyman recalls an instance with the National Comprehensive Cancer Network (NCCN) when a company did not disclose their data, complicating the NCCN guideline update for the hematopoietic growth factor biosimilars since there was not any public display of evidence. As a result, the NCCN did not recommend that agent. Regulatory approval is the first step of approving a biosimilar, but the evidence given to the FDA for review should also be released to the medical community and professional organizations if the agent is expecting to be endorsed, concludes Lyman.