Current Status of Biosimilar Growth Hormone
نویسندگان
چکیده
منابع مشابه
Current Status of Biosimilar Growth Hormone
As the first wave of biopharmaceuticals is set to expire, biosimilars or follow-on protein products (FOPPs) have emerged. The regulatory foundation for these products is more advanced and better codified in Europe than in the US. Recent approval of biosimilar Somatropin (growth hormone) in Europe and the US prompted this paper. The scientific viability of biosimilar growth hormone is reviewed. ...
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Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years. With the expiration of patent exclusivity for the first wave of rhGH products and other biopharmaceuticals, the opportunity emerged for the development of biosimilar medicines. A biosimilar is defined by the European Medicines Agency (EMA) as a biological medicine that is similar to another biological medic...
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ormone therapy (HT) is one of the most prescribed medical regimens in the United States. Before the July 2002 publication of the opposedestrogen arm of the Women’s Health Initiative (WHI), which linked at least 3 years of HT to an elevated risk of invasive breast cancer, an estimated 38% of postmenopausal women in this country were taking HT. In 2000, this group accounted for 46 million prescri...
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BACKGROUND Saliva, which offers a noninvasive and stress-free alternative to plasma and serum, is a widely accepted sample source for analysis of steroids and also of certain amines and peptides. In recent years, numerous publications have described the use of salivary hormone analysis in many fields of clinical and basic research. CONTENT This review provides an overview of the current appli...
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Safety concerns for recombinant human growth hormone (rhGH) treatments include impact on cancer risk, impact on glucose homeostasis, and the formation of antibodies to endogenous/exogenous GH. Omnitrope® (biosimilar rhGH) was approved by the European Medicines Agency in 2006, with approval granted on the basis of comparable quality, safety, and efficacy to the reference medicine (Genotropin®). ...
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ژورنال
عنوان ژورنال: International Journal of Pediatric Endocrinology
سال: 2009
ISSN: 1687-9848,1687-9856
DOI: 10.1155/2009/370329