The biosimilar market is also growing rapidly. In Europe, the share of the European Union’s biologicals market that is subject to competition from biosimilars increased from 9% back in 2013 to 29% in 2018 [2]. The sales of biosimilars have now reached €8.4 billion, which represents 9% of the total biologicals market in 2020, reflecting their value for money [3].

However, the situation in the US is not quite so rosy. There is currently only 19% of the biologicals market, or US$40 billion, already facing some biosimilar competition and biosimilars currently make up only 2.3% of the US biologicals marketplace. Presently, 90% of global biosimilars sales take place in Europe, albeit 60% of overall biologicals sales occurring in the US [4].

Despite the lack of uptake of biosimilars in the US, the pipeline for biosimilars still looks healthy. In fact, in the areas of immunosuppressants, insulin and ophthalmology, no fewer than 23 biosimilars are in the pipeline for the US biosimilar marketplace [5], see Table 1.

Immunosuppressant drugs are a class of drugs that suppress, or reduce, the strength of the body's immune system. Some of these drugs are used to make the body less likely to reject a transplanted organ, such as a liver, heart, or kidney. These drugs are called anti-rejection drugs. Other immunosuppressant drugs are often used to treat autoimmune disorders such as lupus, psoriasis and rheumatoid arthritis.

Insulin biologicals are manufactured insulin (a peptide hormone produced by the pancreas). They are used in the management of type I and type II diabetes (a condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood).

Ophthalmology biologicals include treatments for wet age-related macular degeneration (wet AMD).

Table 1: US pipeline for immunosuppressant, insulin and ophthalmology biosimilars

BLA: Biologics License Application submitted to FDA; SCD: Sam Chun Dang.
Source: GaBI Online Biosimilars of eculizumab, ranibizumab, aflibercept, insulin glargine, insulin aspart, insulin lispro, natalizumab, omalizumab.

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References
1. Derbyshire M, Shina S. Patent expiry dates for best-selling biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars market and opportunities in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Reports/Biosimilars-market-and-opportunities-in-Europe 
3. European Commission. Troein P, Newton M, Scott K. The impact of biosimilar competition in Europe. December 2020 [homepage on the Internet]. [cited 2021 May 21]. Available from: https://ec.europa.eu/health/sites/default/files/human-use/docs/biosimilar_competition_en.pdf
4. GaBI Online - Generics and Biosimilars Initiative. The sluggish US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 21]. Available from: www.gabionline.net/Reports/The-sluggish-US-biosimilars-market 
5. McGowan S, Jesse M, Biehn B. U.S. Biosimilar Report. AmerisourceBergen, April 2021. 

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