Human growth hormone (hGH): biosimilar pricing is not enough, convenience will mandate

After approval of three biosimilar hGH products, the pipeline is full of next generation hGH products with less frequent injection or non-injectable delivery

Barcelona, Spain | October 7, 2008 | The Business Intelligence firm La Merie S.L. conducted an analysis of the R&D pipeline of human growth hormone (hGH, somatropin). The study revealed that Sandoz (the generic division of Novartis) sells the biogeneric somatropin as Omnitrope at a 25 % discount but only achieved 2007 sales of about US$ 8 mln representing a 0.3 % share of the worldwide hGH market in 2007 of US$ 2.7 bln (published data only). Although 2008 sales of Omnitrope are growing steadily, they can be expected to achieve only about US$ 30 mln (about 1 % of the ww market). The number of mere copycat hGH biosimilars in regulated markets is rather limited to a total of three approved biosimilar versions in the EU and/or US and two other versions in the pipeline of 1st generation somatropin biogenerics. The majority of next generation products attempts to improve frequency of administration or delivery. To reduce frequency of SC injections, slow-release formulations are the clinically most advanced approaches followed by the PEGylated versions of hGH which is the preferred option of the established hGH marketers. Engineering of hGH to prolong half-life is a next generation approach already in early clinical development, but still requires injection. In contrast, non-injectable delivery approaches promise to avoid injection by oral, transdermal or nasal administration with the first projects already in phase I/II clinical trials. These results and more were found in the search conducted by La Merie Business Intelligence. The evaluation can be acquired at La Merie’s online store (www.pipelinereview.com/store ).

Human growth hormone (hGH; somatropin) was the first therapeutic protein for which a biosimilar version was approved in the US and in Europe in 2006. There are numerous manufacturers of hGH in non-regulated markets, but most of them do not produce in a manner allowing approval in regulated markets although these products are frequently consumed by those interested in gaining muscle mass. Manufacturers in non-regulated markets are also investing in development of next generation hGH products and some of them invest in WHO-GMP compliant infrastructure.

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SOURCE: La Merie