Science & Innovation


Biosimilars help safeguard future healthcare innovation. They can alleviate some of the burden on healthcare systems by offering cost savings and promoting earlier and sustainable access to therapies. Biosimilars can also expand options for patients and physicians to meet individual needs.

Biosimilars Explained

Biosimilars are medicines that are highly similar to already-approved biologic therapies, known as “reference medicines,” and have no expected clinically meaningful differences in efficacy and safety.1

Benefits of Biosimilars

Biosimilars can offer a range of benefits to multiple stakeholders, enabling a balance of bringing innovative drugs to areas of unmet need, maintaining choice and access for patients and providers, and providing expected savings to the healthcare system.

Therapy Areas

Biogen’s current portfolio of biosimilar medicines spans a number of indications across two distinct therapy areas: ophthalmology and immunology (also described as immunomediated inflammatory disease).

Anti-TNF Therapies (Immunology)

Our portfolio of anti-TNF therapies - used to treat a variety of inflammatory conditions - is marketed in the European Union, where Biogen is a leading provider of these medicines.2

In addition to these marketed products, Biogen is developing two additional immunology biosimilar candidates to be commercialized in major markets worldwide.

Anti-VEGF Therapies (Ophthalmology)

Our existing and pipeline portfolio includes anti-VEGF (Vascular Endothelial Growth Factor) therapies used to treat retinal vascular disorders including neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME) and other leading causes of visual impairment or blindness.

As the current gold standard in the treatment of retinal vascular disorders both in Canada and abroad, these therapies represent a significant amount of spending for the healthcare systems.3

Development and Manufacturing

Biosimilars are biologic products that are engineered to be highly similar to reference products.1 Their development and production process is more complex than that of small molecule drugs and involves expertise with biologics and biologics production.

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Once a suitable biosimilar candidate has been found, its attributes must meet quality requirements regarding similarity to reference product, expected efficacy, and safety.4

Equivalence design for a biosimilar clinical trial must include appropriate indications, patient populations, and treatment administration, among other factors, to ensure comprehensive structural and functional characterization of the new biosimilar product.5

Like all biologics, when the product goes to manufacturing, controls are implemented and it is closely monitored by experienced personnel to ensure batch-to-batch consistency and product stability over time, helping limit residual uncertainty.6 Regulatory authorities perform periodic safety data assessments as well as evaluations of the company’s safety monitoring system. 7

Having successfully delivered complex biologics for over 45 years, Biogen is one of only a handful of companies with the manufacturing capabilities and deep scientific expertise needed to produce biosimilars of advanced biologics.

Future of Biosimilars

Biogen biosimilars are benefiting hundreds of thousands of lives today, and have the potential to treat millions of people in the future.8 Savings that are generated from biosimilars can ultimately be reinvested into the healthcare system - into expanding access to treatment, improving healthcare infrastructure, and providing innovative new medicines.

Facts and Figures


Approved biosimilars in Canada.9


Biosimilar approved in Canada for treatment of retinal disorders, in 2022.9

> $1 billion

Overall yearly savings that biosimilars potentially offer the Canadian healthcare system.10

  1. Government of Canada.  Biosimilar biologic drugs in Canada: Fact Sheet -  Accessed on April 6, 2023.
  3. Patented Medicine Prices Review Board. The cost of drugs for age-related macular degeneration in Canada and internationally. Published 2018. Accessed July 2023.
  4. Webster CJ, George KL, Woollett GR. Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance. BioDrugs. 2021;35(4):379-387.
  5. Stebbing J., et al. Understanding the Role of Comparative Clinical Studies in the Development of Oncology Biosimilars. Journal of Clinical Oncology 38, no. 10 (April 01, 2020) 1070-1080. DOI: 10.1200/JCO.19.02953.
  6. Vulto AG, Jaquez OA. The process defines the product: what really matters in biosimilar design and production? Rheumatology (Oxford). 2017;56(suppl_4):iv14-iv29. doi:10.1093/rheumatology/kex278.
  7. European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). Published September 27, 2012. Accessed September 19, 2022.
  8. Biogen data on file. Accessed July 2023.
  9. Health Canada drug product database, Accessed July 27, 2023.
  10. Patented Medicines Prices Review Board. Biologics in Canada. Part 2: Biosimilar Savings, 2018. Published May 2020. Accessed July 2023.