RESUMO
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.