The Modern Engineering In Biosimiliar Drugs Development As Bioactive Gene Clonning

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dc.contributor.authorKUMAR, VISHWAKARMA RAVIen_US
dc.contributor.authorGUPTA RANDHIR KUMARen_US
dc.contributor.authorMISHRA, Aen_US
dc.date.accessioned2020-09-24T07:33:48Z
dc.date.available2020-09-24T07:33:48Z
dc.date.issued2020-06
dc.description.abstractBio 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.en_US
dc.identifier.affiliationsArya Collage of Pharmacy Ricco Industrial Area Kucas Jaipur Rajasthan -302028.en_US
dc.identifier.affiliationsBabu Banarsi Das National Institute of Technology and management chinut Lucknow - U.P 227108 India.en_US
dc.identifier.affiliationsBabu Banarsi Das National Institute of Technology and management chinut Lucknow - U.P 227108 India.en_US
dc.identifier.citationKumar 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): 1-12en_US
dc.identifier.issn2277-8713
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/203802
dc.languageenen_US
dc.publisherBimonthly published online Journalen_US
dc.relation.issuenumber3en_US
dc.relation.volume9en_US
dc.source.urihttps://www.ijprbs.com/issuedocs/2020/6/IJPRBS%201493.pdfen_US
dc.subjectUSFDAen_US
dc.subjectMonoclonal antibodyen_US
dc.subjectBiosimilar productsen_US
dc.titleThe Modern Engineering In Biosimiliar Drugs Development As Bioactive Gene Clonningen_US
dc.typeJournal Articleen_US
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