Biogen believes biosimilars are important to safeguarding future healthcare innovation. Biosimilars 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.
Science & Innovation
Biosimilars
Benefits of Biosimilars
Biosimilars 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 potential savings to the healthcare system.
Biosimilars are medicines that are highly similar13 to currently available biologic therapies, known as “reference medicines”. Yet biosimilars are unique — they offer the potential to expand patient access to life-changing biologic therapies while generating healthcare sustainability with meaningful cost savings for society. Biosimilars can also expand options for patients and physicians to meet individual needs with greater treatment choice and relevant product or service differentiation.
>70
Approved Biosimilars in Europe Today1
>35
Approved Biosimilars in U.S. Today2
>2.2 b
Cumulative Patient Treatment Days for EU-Approved Biosimilar Medicines3
Carving out space for innovation using biosimilars
Biosimilar treatments give us the opportunity to help more patients at a lower out-of-pocket cost for them. Data from 2021 shows our anti-TNF biosimilars had an associated cost savings of 2.6 billion euros and treated approximately 251,000 patients.15
Biogen Biosimilars Achievements
- Over 250,000 patients on anti-TNF (Anti-Tumor Necrosis Factor) therapy with Biogen biosimilars.
- Currently serving patients with more than 15 indications across immunology and ophthalmology therapy areas.10
- Launched the first ophthalmology biosimilar in the U.S., the first step toward increasing treatment options and reducing the financial burden associated with current anti-vascular endothelial growth factor (anti-VEGF) treatments.
- At least 40% increase in patient access to biological medicines in Europe.16
- Generated an estimated €2.6 billion in European healthcare savings in 20214 and on track to generate more than $3 billion in annual healthcare savings by the end of 2022.
- More than 160,000 patients enrolled in data generation projects (clinical trials, real world evidence studies (RWE), patient registries).
- Millions of doses delivered to patients across Europe.17
- With new launches in ophthalmology and new pipeline assets in immunology, Biogen's aspiration is to enable our growing portfolio of biosimilar solutions to benefit patients worldwide.
Therapy Areas
Biogen’s current portfolio of biosimilar medicines spans a number of indications across two distinct therapy areas: immunology (also described as immunomediated inflammatory disease) and ophthalmology.
Anti-TNF Therapies (Immunology)
Our portfolio of anti-TNF therapies is marketed in the European Union, where Biogen is a leading provider of these medicines.
In addition to these marketed products, Biogen is developing two additional immunology biosimilar candidates to be commercialized in major markets worldwide.
Anti-TNF treatments reduce inflammation and may prevent disease progression by targeting an inflammation-causing substance called Tumor Necrosis Factor (TNF)14.
TNF inhibitors are used to treat inflammatory conditions such as rheumatoid arthritis, psoriatic arthritis, juvenile arthritis, inflammatory bowel disease (Crohn’s disease and ulcerative colitis), ankylosing spondylitis, uveitis, hidradenitis suppurativa, and psoriasis.
Anti-VEGF Therapies (Ophthalmology)
Our existing and pipeline portfolio includes anti-VEGF (Vascular Endothelial Growth Factor) therapies, which are marketed in the US and will be marketed in the European Union in the future, as well as other major markets worldwide including Canada, Japan and Australia.
Anti-VEGF therapies treat retinal vascular disorders, which are a leading cause of blindness. These include neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME*), proliferative diabetic retinopathy (PDR*), visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), and visual impairment due to choroidal neovascularization (CNV).
These therapies are biosimilars, referencing currently available biologic products. By bringing biosimilars to a new therapeutic area, we are expanding treatment options with the goal of sustainably advancing broad, timely access to care for patients in need.
*Products marketed in the United States don’t have the DME or DR indications.
Development and Manufacturing
Biosimilars are biologic products that are engineered to be highly similar to reference products. Their development and production process is more complex than that of small molecule drugs and involves expertise with biologics and biologics production.
Once a suitable biosimilar candidate has been found, its attributes must meet quality requirements regarding similarity to reference product, expected efficacy, and safety.6
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.7
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.8 Regulatory authorities perform periodic safety data assessments as well as evaluations of the company’s safety monitoring system. 9
Biosimilars Pipeline
Visit the pipeline page to find more information.
Biosimilars in the EU
If you are a patient and would like to learn more about biosimilar product availability in countries in the EU, please contact your healthcare provider or visit your local Biogen affiliate website.
Biosimilars Medical Academy
Through our educational and digital initiatives, we aim to provide healthcare professionals with meaningful clinical education to help them in their clinical practice.
The Biosimilars Medical Academy is an educational platform designed by medical professionals to provide high-quality medical education. The Academy delivers exclusive content on biological treatments and educational resources for selected therapy areas using engaging content developed with internationally renowned Key Medical Experts (KMEs).
If you are a healthcare professional based in the United States, click here to access the Biosimilars Medical Academy.
If you are a healthcare professional based in the EU, click here to access the Biosimilars Medical Academy.
Future of Biosimilars
At Biogen, our focus goes well beyond one specific disease or treatment. We want our science to help solve broader issues affecting society while creating access to further innovation.
Realizing the full potential of biosimilars can deliver sustainable, long-term value for patients, physicians, healthcare systems and society as a whole. With the potential to treat millions more people and save billions in healthcare costs, biosimilars are a core pillar of Biogen’s strategy for growth. Our vision for the future is to be among the global biosimilar leaders.
Biogen biosimilars are benefiting hundreds of thousands of lives today, and we have the potential to treat millions of people in the future.
Healthcare systems can invest savings from biosimilars in expanding access to treatment, improving infrastructure, and providing innovative new medicines.
Biogen seeks to unlock the full potential of our biosimilars business by building our pipeline worldwide. Biosimilars will drive growth at Biogen by generating value for our stakeholders while creating savings that healthcare systems can invest in innovative new treatments.
Growth
The biosimilars market is forecasted to be one of the fastest growing segments of the pharmaceutical industry.
Transition
Over $180 billion of originator biologic sales are expected to transition to biosimilars this decade.11
Reducing Costs
Biosimilars are on track to reduce U.S. drug expenditure by $133 billion by 2025.
References
- GABI Generics and Biosimilars Initiative. Biosimilars approved in Europe. Last update: 1 July 2022. : https://www.gabionline.net/biosimilars/general/biosimilars-approved-in-europe. Accessed September 19, 2022.
- FDA-Approved Biosimilar Products. https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed September 19, 2022.
- Spotlight on Biosimilars. Optimizing the Sustainability of Healthcare Systems. Iqvia Institute for Human Data Science. June 2021. https://www.iqvia.com/form-pages/general?redirectUrl=%2f-%2fmedia%2fiqvia%2fpdfs%2finstitute-reports%2fspotlight-on-biosimilars%2fiqvia-institute-spotlight-on-biosimilars.pdf&Name=IQVIA+Institute+Spotlight+on+Biosimilars. Accessed September 21, 2022.
- Biogen Q4 2021 Financial & Business Results. https://investors.biogen.com/static-files/019bc8a4-527e-4565-a58b-91ef680630c1. Accessed September 19, 2022.
- Am Health Drug Benefits. 2013 Sep-Oct; 6(8): 469–478; paragraph 2 under “Barriers to Market Entry” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4031732/. Accessed September 19, 2022.
- Webster CJ, George KL, Woollett GR. Comparability of Biologics: Global Principles, Evidentiary Consistency and Unrealized Reliance. BioDrugs. 2021;35(4):379-387.
- 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.
- 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.
- European Medicines Agency. Questions and answers on biosimilar medicines (similar biological medicinal products). Published September 27, 2012. https://www.medicinesforeurope.com/wp-content/uploads/2016/03/WC500020062.pdf. Accessed September 19, 2022.
- Biogen Q3 2020 Investor Relations Report. Announced previously: https://investors.biogen.com/static-files/9d0b52a8-22b5-4742-af9d-8138469ac89f
- Kabir ER, Moreino SS, Sharif Siam MK. The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy. Biomolecules. 2019 Aug 24;9(9):410. doi: 10.3390/biom9090410. PMID: 31450637; PMCID: PMC6770099. Accessed September 19, 2022.
- Association for Accessible Medicines. (2021, October). 2021 U.S. Generic and Biosimilar Medicines Savings Report. Retrieved from Association for Accessible Medicines: Generics & Biosimilars: https://accessiblemeds.org/resources/reports/2021-savings-report. Accessed September 19, 2022.
- https://www.ema.europa.eu/en/human-regulatory/overview/biosimilar-medicines-overview
- Evangelatos G, Bamias G, Kitas GD, Kollias G, Sfikakis PP. The second decade of anti-TNF-a therapy in clinical practice: new lessons and future directions in the COVID-19 era. Rheumatol Int. 2022 Sep;42(9):1493-1511. doi: 10.1007/s00296-022-05136-x. Epub 2022 May 3. PMID: 35503130; PMCID: PMC9063259.
- Source: Biogen 2022 Annual Meeting of Stockholders; June 15, 2022 (https://investors.biogen.com/static-files)
- Source: https://www.iqvia.com/library/whitepapers/the-impact-of-biosimilar-competition-in-europe
- Source: https://www.businesswire.com/news/home/20181016006181/en/Biogen-and-Samsung-Bioepis-Announce-European-Launch-of-IMRALDI%E2%84%A2-adalimumab-Solidifying-Leadership-in-European-Anti-TNF-Market
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