Helping change the biologic landscape
with the cost-saving potential of biosimilars*

How can I implement biosimilars?

There are 3 practical steps you can take to develop a biosimilar implementation strategy: preparation, implementation, and monitoring. Pfizer has provided resources that help you with these steps, covering operational enablement, informatics/IT, education, and monitoring. Review the “Downloadable Resources” page for materials, including electronic health record (EHR) biosimilar implementation support tools, informational videos, and much more.

What does the approval process for biosimilars involve?

Approved biosimilar medicines are required to have no clinically meaningful differences in terms of safety and efficacy from the relevant reference product. The approval is based on the totality of evidence from analytical, nonclinical, pharmacokinetic, and clinical studies.

What is extrapolation?

Extrapolation is a scientific and regulatory principle that refers to the approval of a biosimilar for use in an indication held by the reference product but not directly studied in a comparative clinical trial with a biosimilar. Extrapolation of efficacy and safety data from one indication to another may be considered if biosimilarity to the reference product has been shown by a comprehensive comparability program including safety, efficacy, and immunogenicity, and there is sufficient scientific justification for extrapolation. Extrapolation is not automatic and is considered only after biosimilarity is established based on the totality of evidence.

What are the potential benefits of biosimilars?

By potentially reducing costs while retaining safety, efficacy, and quality standards, biosimilars may be able to unlock resources that can be reinvested in things like improving patient care. Biosimilars may also help broaden treatment options for prescribers and patients to potentially improve overall health outcomes.