Biosimilar Pricing is Not Enough, Convenience Will Mandate

An Essential Competitor Analysis Report on Human Growth Hormones : Biosimilar Pricing is Not Enough, Convenience Will Mandate

DUBLIN, Ireland — Research and Markets ( has announced the addition of the “Competitor Analysis: Human Growth Hormone (hGH)” report to their offering.

The Competitive Intelligence Report Human Growth Hormone (hGH) as of October 2008 provides a competitor analysis in the development pipeline of biosimilar (biogeneric) versions of somatropin and next generation hGH products for treatment of growth hormone deficiency (GHD) in children and adult, and related diseases. The report includes an evaluation of the hGH market size in 2007 based on published data and provides company pipelines in the field of hGH.

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. Novartis’ generic division Sandoz sells the generic somatropin as Omnitrope at a 25% discount but only achieved 2007 sales of about US$8 million representing a 0.3 % share of the worldwide hGH market in 2007 of US$ 2.7 bln (published data only). Although 2008 sales of Omnitrope are growing steadily, they can be expected to achieve only about US$30 million (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 first 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. 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.

Key Topics Covered:

The report includes a compilation of current active projects in

research and development of novel hGH products. Competitor projects

are listed in a tabular format providing Information on:

– Drug Codes,

– Target / Mechanism of Action,

– Class of Compound,

– Company,

– Territory,

– Indication,

– R&D Stage and

– additional comments with a hyperlink leading to the source of



– 2007 Market Size hGH

– 1st Generation: Somatropin in Regulated Markets

– 1st Generation: Biosimilar Somatropin in Regulated Markets

– 2nd Generation: Injectable Somatropin in SR Formulation in Regulated


– 2nd Generation: Injectable PEGylated Somatropin in Regulated Markets

– 3rd Generation: Injectable Engineered Somatropin in Regulated


– 4th Generation: Non-Injectable Somatropin in Regulated Markets

– 1st Generation: Somatropin in Non-Regulated Markets

– 2nd Generation: Injectable Somatropin in SR Formulation in

Non-Regulated Markets

– 2nd Generation: Injectable PEGylated Somatropin in Non-Regulated


Companies Mentioned:

Corporate R&D Pipelines for Human Growth Hormone (hGH):

– Altus Biopharmaceuticals

– Ambrx

– Anhui Anke Biotechnology

– Asterion

– Aegis Therapeutics

– Bio-ker

– Bio-Sidus

– Biocon

– BioPartners

– Biovel Life Sciences

– Bolder Biotechnology

– Cangene

– Critical Pharmaceuticals

– Daewoong Pharmaceutical

– Dainippon Sumitomo Pharma

– Dong-A Pharmaceutical Co

– Eli Lilly

– Emisphere Technologies

– Ferring

– Flamel Technologies

– Genentech

– GeneScience Pharmaceutical

– HanAll Pharmaceutical

– Hanmi Pharmaceutical

– Ipsen

– JCR Pharmaceutical

– LG Life Science

– Merck Serono

– Modigene

– Nanogene Biopharmaceutical

– Nautilus Biotech

– Neogenica Biosciences

– Neose Technologies

– Novo Nordisk

– OctoPlus

– Pfizer

– Phage Biotechnology

– PharmaEssentia

– Regeron

– Sandoz (Novartis)

– SciGen

– Shenzhen Kexing Biotech

– Tercica

– Teva Pharmaceutical Industries (CoGenesys; Sicor UAB Biotech)

– TransPharma Medical

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