Abhishek Kulshrestha

Principal Scientific manager at Biocon

Abhishek is working as Principal scientific Manager at Biocon. In Biocon, he leads the Biosimilar recombinant human Insulin program for regulated markets. He also leads the bioanalytical functions related to Pharmacokinetics, Immunogenicity and HCP assessment. With close to 10 years of industry experience in biosimilar and biologics development, he has successfully led research teams working on phage display based antibody libraries, mammalian and bacterial cell line development, bioassays and bioanalytical development.

Abhishek has a PhD in Biochemistry from University of Delhi. The work he performed contributed to commercialization of immuno-diagnostic kits which have won various national awards. After a post-doctoral training at National Technological University (Singapore), he joined Reliance Life Sciences (India) to setup and lead Biosimilar monoclonal antibodies and blood product development. The work led to commercialisation of biosimilars in Indian markets of Abciximab (AbcixiRel), Rituximab (RituxiRel), Trastuzumab (TrastiRel), Adalimumab (AdaliRel) and Bevacizumab (BevaciRel).


Title: Biosimilarity assessment- The process of designing biosimilars

  • Quality by design
  • Quality target product profile
  • Analytical similarity
  • Process control
  • Totality of evidence