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’

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

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