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The Recent Trend in Bio-Similar Drugs Development

Author

Listed:
  • Sankha Bhattacharya
  • Shreya Naresh Naik
  • Prachi Jitendra Patel
  • Urvi Gopal Mav

    (Department of Pharmaceutics, Rofel Shri G M Bilakhia College of Pharmacy, India)

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.

Suggested Citation

  • Sankha Bhattacharya & Shreya Naresh Naik & Prachi Jitendra Patel & Urvi Gopal Mav, 2018. "The Recent Trend in Bio-Similar Drugs Development," Global Journal of Pharmacy & Pharmaceutical Sciences, Juniper Publishers Inc., vol. 5(2), pages 47-55, March.
    • Handle: RePEc:adp:jgjpps:v:5:y:2018:i:2:p:47-55
    DOI: 10.19080/GJPPS.2018.05.555660
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    JEL classification:

    • R00 - Urban, Rural, Regional, Real Estate, and Transportation Economics - - General - - - General
    • Z0 - Other Special Topics - - General

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