Biosimilars Versus Reference Biologics
CLEAR

Biosimilars Versus Reference Biologics

More than 30 years ago, the advent of biologic medicines forever changed the way we treat serious illnesses, including inflammatory diseases and cancers.1

Biologics are produced in genetically engineered living cells. They include therapeutic proteins, which replace or augment beneficial human proteins, and monoclonal antibodies, which can strike disease targets with enhanced precision.1,2

Biosimilars are biologic medicines that are highly similar to existing licensed biologic products with no clinically meaningful differences in terms of safety and efficacy.3

BioEngage
Biosimilars are biologics

REFERENCE BIOLOGICS4

BIOSIMILARS4,3

REFERENCE BIOLOGICS4

Long-term studies and real-world experience with reference biologics may help HCPs become more aware of the expected side effects. The history, clinical data, and real-world experience with these products means little about them is unknown.

BIOSIMILARS4,3

A robust totality of evidence must be used to evaluate a biosimilar for market approval; it includes a rigorous assessment of structure, function, animal toxicity, human pharmacology, and clinical studies to assess safety, efficacy, and immunogenicity.

REFERENCE BIOLOGICS4

Because of this experience, HCPs are also confident in the efficacy of branded biologics, because they have seen results with their patients and in clinical data.

BIOSIMILARS4,3

The totality of evidence includes a rigorous assessment of efficacy, safety, and immunogenicity.

References: 1. Biosimilars Resource Center. What are biologics? www.biosimilarsresourcecenter.org/faq/what-are-biologics/. Accessed October 29, 2019. 2. Sathish JG, Sethu S, Bielsky MC, et al. Challenges and approaches for the development of safer immunomodulatory biologics. Nat Rev Drug Discov. 2013;12:206-324. 3. US Food and Drug Administration. Guidance for industry: scientific considerations in demonstrating biosimilarity to a reference product. www.fda/gov/downloads/drugs/guidances.ucm291128.pdf. Accessed October 29, 2019. 4. Boccia R, Jacobs I, Popovian R, de Lima Lopes G Jr. Can biosimilars help achieve the goals of US health care reform? Cancer Manag Res. 2017;9:197-205.

HK-09628-AMGEN-2022-Dec
Date of Approval: Dec 2022