Samsung Bioepis Raises Fresh Questions For Biosimilar Interchangeability

At Least Two Of Eight Humira Biosimilars May Carry Designation

 
• By Dean Rudge
  
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Acknowledging that “different companies have different views and approaches about interchangeability,” Samsung Bioepis has once again called into question the controversial designation.

Competitive edge and business advantage concept as a group of hot air balloons racing to the top but an individualleader with a small balloon attached giving the winning competitor an extra boost.
Will interchangeability provide a true competitive edge? • Source: Shutterstock

Samsung Bioepis has reiterated its belief that the US Food and Drug Administration’s controversial interchangeability designation for biosimilars “may cause misunderstanding and misinterpretation of the scientific rigor that goes into the biosimilar development approvals,” insisting that the badge of interchangeability is not necessary to drive uptake in the US.

The current provisions for the interchangeability designation are “sufficiently covered by the data and the experience accumulated with biosimilars, at...

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An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

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