Opportunities and challenges in biosimilar uptake in oncology.

There are now 10 approved biosimilars in the United States, including 3 oncology drugs, and at least 16 others in late-stage development. The introduction of competition into the biologic space launches a new era in the treatment of cancer, possibly increasing access to the extremely costly biologics. The most important and influential stakeholders for biosimilar acceptance and usage are healthcare providers, such as pharmacists and physicians, as well as patients. Gaining their support requires extensive education, postmarketing pharmacovigilance, resolving concerns about immunogenicity, and allowing interchangeability and substitution. Patients require education on the basic definition of biosimilars versus generic drugs, how biosimilars are tested and approved, costs, and availability of clinical trials. Meanwhile, payers may need to find ways to incentivize physicians to prescribe biosimilars over biologics, as well as to provide information on cost and quality directly to patients in order to drive uptake. Finally, legal challenges to approved and pending biosimilars have limited the market access of these agents.