US biosimilars pipeline for supportive care, oncology and TNF inhibitors

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Biologicals represent many of the most promising new therapies for previously intractable diseases and are becoming increasingly important in the pharmaceuticals market. The global biological market is worth approximately US$276 billion, and in 2018 seven of the top 10 best-selling drugs were biologicals compared with only three in 2008 [1].

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The biosimilar market is also rapidly growing, however, biosimilars currently make up only 2.3% of the US biologicals marketplace. Currently, 90% of global biosimilars sales take place in Europe, despite 60% of overall biologicals sales occurring in the US [2].

Despite the lack of uptake of biosimilars in the US, the pipeline for biosimilars still looks healthy. In fact, in supportive care, oncology and tumour necrosis factor (TNF) inhibitors, no fewer than 39 biosimilars are in the pipeline for the US biosimilar marketplace, see Table 1 [3].

In oncology, therapeutic biologicals are used for the prevention and treatment of various types of cancer. However, biologicals are not exclusive to primary treatment, they have also been developed for supportive oncology treatment as well. Supportive oncological treatment addresses the symptoms that are common with primary chemotherapy.

TNF inhibitors (or anti-TNF drugs) are drugs that help stop inflammation. They are used to treat diseases like rheumatoid arthritis (RA), juvenile arthritis, psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, ulcerative colitis (UC), and Crohn's disease.

Table 1: US pipeline for supportive care, oncology and anti-TNF biosimilars

GW 4147G 2 AmS US Figure 1 V20F26LT
GW 4147G 2 AmS US Figure 1 legend

*Approved in Europe
AZ: AstraZeneca; BLA: biologics license application; FDA: US Food and Drug Administration; Sam: Samsung Bioepis; TNF: tumour necrosis factor.
Source: AmerisourceBergen; GaBI Online biosimilars of filgrastim, epoetin alfa, pegfilgrastim, rituximab, bevacizumab, trastuzumab, infliximab, etanercept, adalimumab

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Approval and launch dates for US biosimilars

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. The sluggish US biosimilars market []. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 26]. Available from:
3. McGowan S, Jesse M. Biosimilars pipeline report. AmerisourceBergen. May 2020.

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