Carving out space for innovation using biosimilars

Nicole, a rheumatoid arthritis patient in Germany

A look inside any healthcare system would undoubtedly reveal the struggle to reduce costs yet offer the best treatments possible for patients. Health authorities and payers search for ways to balance bringing innovative drugs to areas of unmet need, while maintaining choice and access for patients and providers in more established diseases. This is especially important for chronic immunology-related conditions, where biologic therapies (large, complex biological compounds that are made by living cells rather than being manufactured chemically like most other drugs) can have a transformative impact for patients. It is within this interplay that biosimilars can play an important role in helping patients, physicians, payers and society as a whole.

Biosimilars are prompting a healthcare revolution across Europe, enabling greater patient access to life-changing biologic therapies while enhancing healthcare sustainability worldwide.

 

A closer look at biologics and biosimilars

Biosimilars are medicines that are highly similar (but not identical) to currently available biologic therapies known as originators.1 Based on available products (whose patents have expired) the biosimilars aim to reduce treatment costs while also being nearly identical to their reference biologics.2,3 Because biosimilars utilize copies of biologics, they are also more likely to make it to market and are less risky than a new treatment. These products cost-effectively enable expanded access to life-changing treatments while also incorporating innovation to bring a best-in-class experience for patients and physicians. 

“One of the great healthcare challenges facing our society today is how to get patients on highly-effective, established treatments while also creating space for innovation,” said Ian Henshaw, Senior Vice President and Head of Global Biosimilars Unit at Biogen.  “Biosimilars provide health systems with viable, cost-effective alternatives, thus allowing for investment in new technologies and treatments in other areas.”

Ian Henshaw, Senior Vice President and Head of Global Biosimilars Unit

Unlike small-molecule generics, such as aspirin, biologics and biosimilars are large-molecule drugs with 5,000 to 50,000 atoms on average and produced in living organisms.4 Whereas biologics are the first of their kind, biosimilars are copies, yet no exact copy can be made in the highly detailed production process.5 To make sure biosimilars have the same efficacy and safety, regulatory authorities require Phase 1, as well as controlled and randomized Phase 3, studies in which manufacturers must provide evidence of equivalence in pharmacokinetics and pharmacodynamics.6

These complexities are multiplied exponentially when manufacturing on a large scale, along with other hurdles like transportation and storage.

A 40-year legacy in biologics

Having successfully delivered complex originator biologics for approximately 40 years, Biogen is among few companies with the skill and experience needed to provide biosimilars of advanced biologics.7 To optimize capabilities, Biogen formed a joint venture in 2012 with Samsung BioLogics, called Samsung Bioepis, to jointly develop, distribute and market biosimilars of advanced biopharmaceuticals.8

In Europe today, and specifically in Germany, Biogen is leading the way with anti-TNF biosimilars in chronic, inflammatory conditions such as rheumatoid arthritis, Crohn’s disease and psoriasis, among others.9 The impact on patient access is striking; in Germany, for example, the number of patients receiving anti-TNF treatments has grown by more than 30% since the introduction of biosimilars.10

“Living with a chronic, progressive disease, I knew that my sore joints would only get worse the longer that I had to wait for treatment,” said Nicole, a patient living in Germany with rheumatoid arthritis. “Having access to the right treatment at the right time made a real difference in my quality of life.”

Nicole, a rheumatoid arthritis patient in Germany

New data estimates that approximately 220,000 patients from more than 30 countries in Europe have been treated with Biogen’s anti-TNF biosimilars as of September 30, 2020, with associated cost savings for European healthcare systems of an estimated 1.8 billion euros11 in 2019.  

For physicians, biosimilars provide more choices. And for Biogen, biosimilars create an entirely new value-chain and a competitive advantage – yet another example of the company’s pioneering spirit. Biogen is inspired by helping patients live fuller, healthier lives. The biosimilars unit keeps this central to their operations and has established an outstanding track record of supply, never missing a patient dose.

 

The next chapter

Unlocking the potential of biosimilars anti-TNF portfolio while complementing Biogen’s presence in ophthalmology is a key strategic priority for the company.  In 2019 Biogen built on its commitment to providing biosimilars (referencing Lucentis® and Eylea®) by securing exclusive rights from Samsung Bioepis for new potential ophthalmology biosimilars in major markets world-wide including the U.S., Canada, Europe, Japan and Australia.12 These potential treatments may be used for such widespread ophthalmologic conditions as neovascular (wet) age-related macular degeneration, macular edema, and diabetic retinopathy, among others, and could be the foundation of Biogen’s presence in the ophthalmology space.

The further expansion of our biosimilars portfolio provides payers and health systems globally the budgetary headroom to fund innovation. Biogen’s biosimilars make it viable to provide more patients with earlier and longer access to treatment, changing their lives for the better.

“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,” says Henshaw. “Our work in biosimilars bridges these goals and has made a real difference for patients, helping transform the lives of hundreds of thousands of patients to date and potentially millions more in the future.” 

 

 

 

1FDA website, “Biosimilar and Interchangeable Products,” paragraph 6 entitled “What is a biosimilar product?” https://www.fda.gov/drugs/biosimilars/biosimilar-and-interchangeable-products accessed November 2, 2020
2 Am Health Drug Benefits. 2013 Sep-Oct; 6(8): 469–478; paragraph 3 under “Market Opportunities”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4031732/, accessed November 2, 2020
3 World J Clin Cases. 2018 Aug 16; 6(8): 161–166; abstract, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6107532/, accessed November 6, 2020
4Generics and Biosimilars initiative, paragraph 3, http://www.gabionline.net/Biosimilars/Research/Small-molecule-versus-biological-drugs, accessed November 2, 2020
5Am Health Drug Benefits. 2013 Sep-Oct; 6(8): 469–478; paragraph 1 and 2 under “Barriers to Market Entry”
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4031732/, accessed November 2, 2020
6BMJ, 2017; Volume 1, Issue 1; The biosimilar approval process: how different is it? Section: Considering the manufacture and approval of a biosimilar. https://considerations.bmj.com/content/1/1/3, accessed November 2, 2020
7Am 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 November 6, 2020
8Biogen announcement: https://investors.biogen.com/news-releases/news-release-details/samsung-biologics-and-biogen-idec-announce-formation-biosimilars, accessed November 6, 2020
9Centers for Biosimilars, paragraph 3. https://www.centerforbiosimilars.com/conferences/smi-2019/biogen-director-shares-lessons-learned-from-eu-biosimilar-commercialization, accessed November 6, 2020
10Biogen data on file.
11Biogen Q3 2020 Investor Relations Report. Announced previously: https://investors.biogen.com/static-files/9d0b52a8-22b5-4742-af9d-8138469ac89f, accessed November 6, 2020
12Biogen news https://investors.biogen.com/news-releases/news-release-details/biogen-expand-biosimilars-portfolio-and-gain-access-additional, accessed November 2, 2020