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.Since 2015, when the FDA approved the first biosimilar under the Biologics Price Competition and Innovation Act of 2009, 9 additional biosimilars have received agency approval, including 3 with an oncology indication. Although tbo-filgrastim was approved under the traditional drug approval pathway, many viewed this approval as an example of what biosimilars would look like in the United States following the first approved biosimilar in the European Union. By January 2018, at least 60 biosimilars were enrolled in the FDA’s biosimilar development program, with FDA commissioner Scott Gottlieb, MD, reporting that the agency had received requests for meetings to discuss biosimilars for 27 distinct reference biologics.