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US biosimilars pipeline for growth hormone and infertility drugs

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Global spending on medicines reached US$1 trillion in 2014 and was expected to rise to US$1.2 trillion by 2017 [1], with biologicals making up an increasing part of this total due to their use to treat previously intractable diseases. In fact, spending on biologicals has doubled since 2007 and growth has outstripped that of total sales of pharmaceuticals by a significant margin. 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 [2].

The increasing cost of medicines, and especially biologicals, is putting increasing strain on healthcare budgets and is therefore pushing the growth in the biosimilars market share. 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 [3].

In the US, however, biosimilars currently make up only 2.3% of the US biologicals marketplace. In fact, 90% of global biosimilars sales take place in Europe, despite 60% of overall biologicals sales occurring in the US [4].

Despite this lack of uptake of biosimilars in the US, the pipeline for biosimilars still looks healthy. In fact, in the areas of growth hormones and infertility, there are six biosimilars in the pipeline for the US biosimilar marketplace, see Table 1 [5].

Growth hormone is a protein hormone of about 190 amino acids that is synthesized and secreted by cells called somatotrophs in the anterior pituitary. It is a major participant in control of several complex physiologic processes, including growth and metabolism. Biologicals, such as Genotropin (somatropin), are used to treat growth failure in children and adults who lack natural growth hormone.

Infertility treatments, such as Gonal-F, are generally naturally occurring hormones that are used to stimulate a follicle (egg) to develop and mature. Gonal-F is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature.

Table 1: US pipeline for infertility and growth hormone biosimilars

CRL: contract research organization; SC: subcutaneous.
Source: AmerisourceBergen, GaBI Online biosimilars of somatropin, somapactin, corifollitropin alfa, follitropin alfa, follitropin delta

Approval and launch dates for US biosimilars

References
1. GaBI Online - Generics and Biosimilars Initiative. The global biologicals market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Reports/The-global-biologicals-market
2. 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
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars market and opportunities in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Reports/Biosimilars-market-and-opportunities-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. The sluggish US biosimilars market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 3]. Available from: www.gabionline.net/Reports/The-sluggish-US-biosimilars-market
5. McGowan S, Jesse M. Biosimilars pipeline report. AmerisourceBergen, May 2020.

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