Biologicals are becoming increasingly important in the pharmaceuticals market due to their use to treat chronic diseases. The global biologicals market in 2020 was worth approximately US$239.2 billion, and in 2020 five of the top 10 best-selling drugs were biologicals compared with a high of seven in 2018, and only three in 2008 .
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 . 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 .
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 .
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 , 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.
US biosimilars pipeline for growth hormone, infertility and bone health drugs – 2021
US biosimilars pipeline for supportive care, oncology and TNF inhibitors – 2021
Approval and launch dates for US biosimilars – 2021
LATIN AMERICAN FORUM – Coming soon!
To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.
Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.
LATIN AMERICAN FORUM – Próximamente!
Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.
Regístrese para recibir el boletín informativo GaBI Latin American Forum. Informe a colegas y amigos sobre esta nueva iniciativa.
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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