The Recent Trend in Bio-Similar Drugs Development

Sankha Bhattacharya, Shreya Naresh Naik, Prachi Jitendra Patel and Urvi Gopal Mav
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Urvi Gopal Mav: Department of Pharmaceutics, Rofel Shri G M Bilakhia College of Pharmacy, India

Global Journal of Pharmacy & Pharmaceutical Sciences, 2018, vol. 5, issue 2, 47-55

Abstract: The patent expiry of various biological medicines has led to developed Bio-Similar drugs across the globe. This article reviews the various approved Bio-Similar drugs in India and the challenges of Bio-Similar drugs for getting marketing approval. USFDA guideline clearly said that Bio-Similar drugs are not generic medications nor identical to the innovator medicine and also it’s not ensuring therapeutic equivalence with innovator drug. Getting Bio-Similar product marketing approval is a challenging task. To improve access of Bio-Similar drugs within the US market, US-FDA allows abbreviated pathway for their approval. Recently India is becoming a most preferable destination for Bio-Similar manufacturers, because of Make in India program. Introduction of recombinant technique to prepare Monoclonal antibody based Bio-Similar drug becoming popular within pharmaceutical manufactures because of many recent patent expiries of Biologics. The biologies are produced by cell culture method; hence, chances of variability’s are more as comparable with the chemically synthesized conventional medicine. Therefor it is impossible to produce an identical 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 face challenges regarding verification of the similarity, the interchange ability, unique naming to differentiate the various Bio-Pharmaceutical products, commercial opportunities, IPR and public safety.

Keywords: juniper publishers:Journal of Pharmacy; Global Journal of Pharmacy; Pharmaceutical Sciences; Pharmacy & Pharmaceutical Sciences; pharmaceutical sciences journals; omics online; open access; drug discovery; Clinical Trials; juniper publishers open access journals; juniper publishers reivew (search for similar items in EconPapers)
Date: 2018
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DOI: 10.19080/GJPPS.2018.05.555660

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