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WHAT IS A biosimilar?

Let’s learn more about what biosimilars are and the process for developing them

WHAT DO biosimilars MEAN for ME?

Let’s explore how biosimilars may potentially expand treatment options to meet the growing demand for biologic therapies

WHAT iS Pfizer’s ROLE?

Let’s learn more about how Pfizer builds on its experience with biologics through Pfizer Biosimilars

biosimilars by the Numbers


biologic products

Over 100 biologic products will lose patent or will have lost protections by 2022




Biosimilars have been associated with $37 billion in savings since the passage of the Biosimilars Act in 2010, and are projected to produce an estimated $104 billion in savings from 2020-2024, based on a September 2020 IQVIA report



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Pfizer has more than 12 years of experience producing biosimilars globally


Pfizer standards

at work

What is Pfizer's commitment to manufacturing biosimilars?

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frequently asked questions

What does the approval process for biosimilars involve?
Approved biosimilar medicines are required to have no clinically meaningful differences in terms of safety, efficacy, purity, or potency from the relevant reference product and are 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.

Transitioning to value-based care? Learn How Biosimilars may help