Definition: biosimilar
A biosimilar is a recombinant protein which is engineered to be highly similar to a reference protein with regard to its biochemical fingerprint. The biosimilar and reference product have no clinically meaningful differences in their critical quality attributes (CQAs).3
The term ‘biosimilar’ also refers to a regulatory designation given by the US FDA and EMA. These organizations define a biosimilar as a biological product with no clinically meaningful differences from an already authorized biologic reference product.1,2
References
1.FDA. Biosimilars: review and approval. Available at: https://www.fda.gov/drugs/biosimilars/review-and-approval, accessed October 2024.
2.EMA. Biosimilar medicines: overview. Available from: https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview
3.Vulto AG & Jaquez OA. Rheumatology (Oxford). 2017;56(Suppl 4):iv14–iv29.
4.Vandekerckhove K, et al. AAPS J. 2018:20(4):68.
5.AAO – Biosimilars in ophthalmologic practice. Biosimilars. Available from: https://www.aao.org/eyenet/article/biosimilars-in-ophthalmology, accessed October 2024.
6.Barbier L, et al. J Pharm Policy Pract. 2021;14(1):53.
7.EMA. Approved biosimilar products. Available from: https://www.ema.europa.eu/en/medicines, accessed October 2024;
8.FDA. Approved biosimilar products. Available from: https://www.fda.gov/drugs/biosimilars/biosimilar-product-information, accessed October 2024;
9.MHRA. Guidance on the licensing of biosimilar products. Available from: https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products, accessed October 2024.
10.Health Canada. Guidance document: Information and submission requirements for biosimilar biologic drugs. Available from: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radiopharmaceuticals-genetic-therapies/applications-submissions/guidance-documents/information-submission-requirements-biosimilar-biologic-drugs-1.html, accessed October 2024
11.Swissmedic. Guidance document on biosimilars. Available from: https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/information/anpassung-wl-zl-biosimilar.html, accessed October 2024
12.FDA. Safety Outcomes When “Switching” Between Biosimilars and Reference Products. Available from: https://www.fda.gov/drugs/spotlight-cder-science/safety-outcomes-when-switching-between-biosimilars-and-reference-products, accessed October 2024.
Abbreviations:
CQAs Critical Quality Attributes
EMA European Medicines Agency
FDA Food and Drug Administration (USA)
MHRA Medicines and Healthcare products Regulatory Agency (UK)
QTPP Quality Target Product Profile
Learn more
About the concept of biosimilars in the publications and animations.
Vulto AG and Jaquez A, 2017 Rheumatology (Oxford) 1;56
The Process Defines the Product: What Really Matters in Biosimilar Design and Production?
Biologic drugs are highly complex molecules and their key characteristics (known as critical quality attributes or CQAs) can vary based on posttranslational modifications that occur. The extent of variation in each CQA must be matched by biosimilar developers to the originator molecule to ensure biosimilarity. As analytical tools that measure differences at the molecular level are more sensitive and specific than tools that measure clinical differences, for example in clinical trials, biosimilar development has a greater focus on preclinical attributes, with phase 3 trials (if needed) being confirmatory. A well-controlled manufacturing process ensures that biosimilars consistently match the fingerprint of the originator molecule.
European Commission, Consensus Information Paper 2019.
What You Need to Know about Biosimilar Medicinal Products
The European Commission has prepared this paper in order to provide payers, physicians and patients with adequate information on biosimilars. It gives a detailed overview of biologics and biosimilars, regulation and development of biosimilars, potential economic consequences of using biosimilars, as well as Q&A sections for each of the key stakeholders.
