Biosimilars need huge investments, longer timelines

(Ref: Business Line)
  • Biocon managing director Kiran Mazumdar-Shaw described the challenges faced the drugmaker in its successful bid to win FDA approval for its biosimilar version of trastuzumab, Business Line reported Wednesday.

  • "Unlike small molecule generic drugs, the development of biosimilars is a highly expensive, complex and time-consuming exercise," noted Mazumdar-Shaw, continuing "this is because biosimilars are large and complex target-specific molecules, placed at the high end of the pharma value chain."

  • "Most Indian companies which have been successful in generics but have shied away from this space and have not made serious bets," the executive said, adding "Biocon was among the earliest pharma companies in India to spot the opportunity offered by patent expirations on expensive innovator biologic drugs."

  • Mazumdar-Shaw stated that Biocon has fared better than its Indian peers because it made "a differentiated long-term play in the biologics and biosimilars space."

  • Regarding price controls, the managing director remarked "while I agree we need to increase access through affordable pricing and some of the drugs need to be under price control, I don't agree with the current formula for calculating drug price caps."

  • "Our suggestion for an equitable formula of calculating price caps is to take the top 10 companies and compare their price variance to arrive at the ceiling price," Mazumdar-Shar commented.

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