Case Study Mitigating Risk in Biosimilar Development

With an expected $67 billion worth of licenses on organic items lapsing before 2020 and governments forced to diminish quickly rising human services costs, biosimilars speak to a noteworthy open door for the pharmaceutical business. Biosimilars are exceptionally like their authorized reference item not withstanding minor contrasts as excipients in the plan; likewise there are no wonderful contrasts between the biologicals and the reference item as far as wellbeing, immaculateness, and strength. However, until a global development strategy is adopted, regulatory, therapeutic and legal challenges remain.

  •  Impact of FDA Guidance on Substitution Policies
  • Chronicles of a Biosimilar Production Facility 
  • challenges in developing monoclonal biosimilars
  •  Impact of FDA Guidance on Substitution Policies
  • Chronicles of a Biosimilar Production Facility 
  • challenges in developing monoclonal biosimilars

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