Biosimilars on the horizon

Biosimilares/General | Posted 23/05/2014 post-comment0 Post your comment

Europe approved its first monoclonal antibody biosimilar, Inflectra/Remsima (infliximab), in September 2013 [1]. But how does the pipeline look for biosimilars and what will be the next biosimilar to be approved?

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The future is looking bright for forthcoming biosimilar launches. According to research carried out by Decision Resources the number of publicly-disclosed biosimilars development projects has increased over 40% in the last 12 months. Although the majority of these development projects are yet to enter clinical development, a 20% increase in the number of biosimilars in clinical trials over the last year indicates substantial advancement in the late-stage pipeline.

The most popular biosimilar targets include monoclonal antibodies and Amgen’s arthritis blockbuster Enbrel (etanercept). Despite it also being under threat from biosimilars competition for its originator biologicals, biopharmaceutical company Amgen is also predicted to be the first on the market for three of the most popular biosimilars, see Table 1.

Table 1: The most popular biosimilar targets under development

Originator brand-name Active substance Originator company Therapeutic area 2013 sales (US$ billion) No. of biosimilars in development Biosimilar front runner
Avastin bevacizumab Roche Bowel/breast/colon cancer 7.0 15 Amgen
Enbrel etanercept Amgen/Pfizer Arthritis Psoriasis 8.3 27 Sandoz/Samsung Bioepis
Herceptin trastuzumab Roche Breast/stomach cancer 6.8 21 Amgen
Humira adalimumab AbbVie Arthritis
Ulcerative colitis
Crohn disease
10.7 13 Amgen
Rituxan rituximab Roche Arthitis
lymphoma (NHL)
8.6 35 Boehringer Ingelheim
Total 49.8 125  

Source: EMA, FirstView Biosimilar Index

With almost US$50 billion in sales up for grabs it is perhaps not surprising that an estimated 125 biosimilars are in development for just these five biologicals.

Although Amgen is estimated will be the first to get a trastuzumab biosimilar approved they may have a fight on their hands. South Korean biotechnology company Celltrion already received approval for its trastuzumab biosimilar (Herzuma) from the Korean Ministry of Food and Drug Safety (MFDS) in January 2014 [2].

It is predicted that approximately 15 biosimilar target molecules patents will expire over the next few years and that the global biosimilars market will increase to US$23 billion in 2019. Biosimilar targets for the future include arthritis treatment Orencia (abatacept), osteoporosis treatment Prolia (denosumab), psoriasis treatment Stelara (ustekinumab) and cancer drug Yervoy (ipilimumab).

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Celltrion starts phase III biosimilar trastuzumab trial

1. GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 23]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar trastuzumab approved in Korea []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 23]. Available from:

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