Biosimilars: the future is bright

The first biosimilar was approved by the European Union in 2006.1 Since then, the number of approved biosimilars has increased worldwide, and they are expected to play an increasingly important role in health care.1,2

What are biosimilars?

A biosimilar is a biological product designed to be highly similar to its reference product.5,6 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.7,8 It’s a highly skilled, multistep process to ensure that there are no clinically meaningful differences between the biosimilar and the reference product.6,7

Health care savings

Typically, there is a lower cost of development for a biosimilar than that of its reference biologic. This lower cost can help reduce the financial impact of medications on the health care system. Plus, it can help provide more treatment options for potentially deadly diseases like cancer.2

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.6

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.6,7

Interchangeability of biosimilars

While most generic drugs can be substituted by a pharmacist for the branded reference product, the same is not necessarily true for biosimilars. Only biosimilars that undergo additional analyses to support an FDA designation of “interchangeable” can be substituted by a pharmacist for a prescribed reference biologic, where consistent with state pharmacy laws.10

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 December 21, 2018. 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 December 21, 2018. 3. The Biosimilars Council. Biosimilars in the United States: Providing More Patients Greater Access to Lifesaving Medicines. www.biosimilarscouncil.org/wp-content/uploads/2017/09/Biosimilars-Council-Patient-Access-Study-090917.pdf. Accessed December 21, 2018. 4. Allied Market Research. Biosimilars Market (Follow-on-Biologics) by Types (Human Growth Hormone, Erythropoietin, Monoclonal Antibodies, Insulin, Interferon, Granulocyte-colony Stimulating Factor, Peptide) and Application (Blood Disorders, Oncology Diseases, Growth Hormone Deficiencies)-Global Opportunity Analysis and Industry Forecast, 2014-2020. www.alliedmarketresearch.com/global-biosimilars-market. Accessed December 21, 2018. 5. European Medicines Agency. Questions and Answers on Biosimilar Medicines (Similar Biological Medicinal Products). www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf. Accessed December 21, 2018. 6. 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 December 21, 2018. 7. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411-419. 8. Cortés J, Curigliano G, Diéras V. Expert perspectives on biosimilar monoclonal antibodies in breast cancer. Breast Cancer Res Treat. 2014;144:233-239. 9. Grewal S, Ramsay S, Balu S, Carlson JJ. Cost-savings for biosimilars in the United States: a theoretical framework and budget impact case study application using filgrastim. Expert Rev Pharmacoecon Outcomes Res. 2018;18:447-454. 10. US Food and Drug Administration. Biosimilar and Interchangeable Products. www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm580419.htm. Accessed January 23, 2019. 11. US Food and Drug Administration. Draft Guidance for Industry: Considerations in Demonstrating Interchangeability With a Reference Product. www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm537135.pdf. Accessed January 23, 2019.