Current Challenges in Developing Biosimilars

The generic version of biologicals- “Biosimilars” is the new buzz word in the world of pharmaceutical industry. Biosimilars are highly similar to their licensed reference product not withstanding minor differences as excipients in the formulation; also there are no remarkable differences between the biologicals and the reference product in terms of safety, purity, and potency. However, there are certain challenges in way of its development and receiving a green signal for launching into the market.

In Phase I trial of certain biosimilars and biologics, 6/8 patients developed serious adverse events like organ failure, respiratory distress. Initial signs usually appeared 50–90 min after dosing produced by ‘Cytokine Release Storm’

  • Current concepts of drugs and biologics
  • Unique considerations for biologics
  • Early clinical development essentials
  • Late clinical development essentials
  • Drug Safety essentials
  • Advertising, promotion and labeling essentials
  • Cancer therapeutics
  • Comparability for Biologics

Related Conference of Current Challenges in Developing Biosimilars

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Current Challenges in Developing Biosimilars Conference Speakers

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