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


Potential

100
biologic products

Over 100 biologic products will lose patent or other protections by 2022

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savings

$250
billion

Amount of possible savings 11 likeliest biosimilars could create between 2014 and 2024 in the US

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experience

10
YEARS

Pfizer has nearly 10 years of biosimilars experience outside the US

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Pfizer standards

at work

What's 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 high 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.