Pharmaceutical Regulatory Affairs: Open Access

Rushvi P

Publications

• Review Article
  Biosimilars: an Emerging Market Opportunities in India
  Author(s): Rushvi P, Charmy K, Nirav C and Narendra CRushvi P, Charmy K, Nirav C and Narendra C
  
  In recent few years, there are many epic Biological products are going off patent which has generated an abridged route for the Biosimilars products which relies on the extensive comparability testing against Reference Biological Products (RBP) assuring product’s quality, safety and efficacy. Biosimilars are product similar to biologics but not indicate to them. Thus they require distinct marketing approval with abounding documentation as they are not generic version of biologics. These made regulatory and administrators of different countries to establish strict balance between the cost be.. Read More»
  DOI: 10.4172/2167-7689.1000165

  Abstract PDF