Biosimilars already approved and in development
نویسندگان
چکیده
منابع مشابه
Biosimilars Entry And Price Development In Europe.
In light of the increasing interest in pricing and entry of biosimilars in Europe, this research has found that the market of filgrastim biosimilars is dominated by the entry effect, while that of epoetins is driven by the competition effect. The epoetins market gets saturated relatively faster in terms of number of local competitors, which can be explained by the molecular complexity of that m...
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[1]. In order to evaluate biosimilarity between an innovator and biosimilar product, the FDA recommended a stepwise, riskbased totality of evidence approach. In addition to extensive structural and functional characterization, effort must also be made on preclinical development in terms of animal toxicity studies and the assessment of pharmacokinetics (PK) and immunogenicity. Although there are...
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ژورنال
عنوان ژورنال: Considerations in Medicine
سال: 2017
ISSN: 2515-3919,2515-3927
DOI: 10.1136/conmed-2017-100004