What Are Biosimilars

Biosimilars 101

Biosimilars: the future is bright

The first biosimilar was approved by the European Union in 2006. Since then, the number of approved biosimilars has increased worldwide, and they are expected to play an increasingly important role in healthcare.1,2

What are biosimilars?

A biosimilar is a biological product designed to be both highly similar to, and have “no clinically meaningful differences” from, its reference product. It’s important to remember that biosimilars are not generic drugs. Biosimilars are up to 1,000 times the size of small molecule generic drugs, and are far more structurally complex.3-6

Biosimilars clinical trial requirements: a totality of evidence

The clinical testing requirements for biosimilars differ from those of the reference product. Still, biosimilars manufacturers must submit robust data, such as extensive analytical studies, plus nonclinical and clinical evidence. This totality of evidence is required before a biosimilar is approved for the market.4

Extrapolation: approval for multiple indications

Regulatory agencies review the totality of evidence to determine whether the biosimilar can be approved for some or all of the indications of the reference product.7

Non-comparables are not biosimilars

It is important to distinguish between biosimilars and noncomparable biologics. Non-comparables (also known as “biocopies,” “biomimics,” “intended copies,” and “nonregulated biologics”) are copies of licensed biologic medicines that are marketed in some countries, but have not followed the rigorous regulatory pathways required for biosimilars. Although non-comparables may be intended copies of the reference product, they have not been subjected to the same strict analytical, nonclinical, and clinical comparative evaluations prior to market approval as biosimilars regulatory pathways mandate.8,9

As a result, these products may have clinically significant differences in quality, efficacy, and safety compared with their reference products. Certain non-comparables have been shown to have reduced biological potency or higher rates of adverse events, underscoring the importance of following a stringent regulatory pathway for the approval of all biologic medicines.8

The World Health Organization (WHO) has issued a roadmap for member states to review non-comparables with the same stringent regulatory assessments as that of current biosimilars review standards.10

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References: 1. European Medicines Agency. Biosimilars in the EU: information guide for healthcare professionals. www.ema.europa.eu/documents/leaflet/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed October 29, 2019. 2. US Food and Drug Administration. Biosimilars action plan: balancing innovation and competition. www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm613761.pdf. Accessed October 29, 2019. 3. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). www.medicinesforeurope.com/wpcontent/uploads/2016/03/WC500020062.pdf. Accessed October 29, 2019. 4. 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. 5. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 6. Lee JF, Litten JB, Grampp G. Comparability and biosimilarity: considerations for the healthcare provider. Curr Med Res Opin. 2012;28:1053-1058. 7. US Food and Drug Association. Biosimilar and interchangeable products. www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products. Accessed October 29, 2019. 8. Dörner T, Kay J. Biosimilars in rheumatology: current perspectives and lessons learnt. Nat Rev Rheumatol. 2014;11:713-724. 9. Mysler E, Pineda C, Horiuchi T, et al. Clinical and regulatory perspectives on biosimilar therapies and intended copies of biologics in rheumatology. Rheumatol Int. 2016;36:613-625. 10. World Health Organization. Guidance on scientific principles for regulatory risk assessment of biotherapeutic products. www.who.int/biologicals/ WHO_Risk_Assessment_ for_BTP_2nd_PC_10_Dec_2014.pdf. Accessed October 29, 2019.

Date of Approval: Dec 2022