An overview of biosimilars
作者： Nagaraj B Malipatil , Kiran Haridas , Shruthi D Prithvi
DOI:
关键词: Incurable diseases 、 Biotechnology 、 Innovator 、 Population 、 Risk analysis (engineering) 、 Medicine 、 Pharmaceutical market 、 Biological drugs 、 Biosimilar
摘要: Biosimilars are surmounting pharmaceutical market from last three decades and sale increasing progressively. Advances in the biotechnology lead to development discovery of new biological products treat various life-threatening diseases. drugs that produced after expiry patent approved innovator. This review attempt highlight differences between biosimilars chemical generics, stages, issues concern with use need appropriate regulations for their approval. Generic approach is not scientifically useful manufacture biosimilars. have more structural complexity, multi-layered manufacturing or scale-up process risk immunogenicity; therefore required unique regulatory pathways introduce them market. Safety efficacy biosimilar essential parameter increase access population. can ensure cost-effective treatment invade incurable diseases due enhanced competition pharma/biotech industries it. Keywords: Biosimilars, Biologics, Follow-on biologics, drugs, Subsequent-entry biologics.
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innovareacademics.in 参考文章(33)
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