The Modern Engineering In Biosimiliar Drugs Development As Bioactive Gene Clonning
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Date
2020-06
Journal Title
Journal ISSN
Volume Title
Publisher
Bimonthly published online Journal
Abstract
Bio therapeutic product tends to similar properties like- efficacy, Safety and qualityto a licensed bio- originator. USFDA guideline clearly said that Bio-Similar drugs are not genericmedications nor identical to the innovator medicine and also it’s not ensuring therapeuticequivalence with innovator drug. Getting Bio-Similar product marketing approval is achallenging task. To improve access of Bio-Similar drugs within the US market, US-FDA allowsabbreviated pathway for their approval. Recently India is becoming a most preferabledestination for Bio-Similar manufacturers, because of Make in India program. Introduction ofrecombinant technique to prepare Monoclonal antibody based Bio-Similar drug becomingpopular within pharmaceutical manufactures because of many recent patent expiries ofBiologics. The biologies are produced by cell culture method; hence, chances of variability’s aremore as comparable with the chemically synthesized conventional medicine and variousbiological medicines has led to developed Bio-Similar drugs across the globe. The biologies areproduced by cell culture method; hence, chances of variability’s are more as comparable withthe chemically synthesized conventional medicine. Therefor it is impossible to produce anidentical copy of an innovator product; hence, Bio-Similar is not considered as generic drugs.These drugs are Twin but not a clone of the innovator drug. The Bio-Similar drugs always facechallenges regarding verification of the similarity, the interchange ability, unique naming todifferentiate the various Bio-Pharmaceutical products, commercial opportunities, IPR andpublic safety.
Description
Keywords
USFDA, Monoclonal antibody, Biosimilar products
Citation
Kumar Vishwakarma Ravi, Gupta Randhir Kumar, Mishra A. The Modern Engineering In Biosimiliar Drugs Development As Bioactive Gene Clonning. International Journal of Pharmaceutical Research and Bioscience (IJPRBS). 2020 Jun; 9(3): 1-12