Monday, December 19, 2011

FDA meets to discuss fee program for biosimilars

Last week, the FDA met with the Pharma industry to discuss the fee program for the pathway for biosimialrs, which is expected to be published soon.  These fees would go into place October 1, 2012, the Fiscal Year, and last through Fiscal Year 2017.

The four categories discussed during this meeting were:
  • -Biosimilars Product Development Fees
  • -Marketing Fees
  • -Establishment Fees
  • -Product Fees
In exchange for these fees, the FDA would create a series of goals to meet with both new biosimilars products and resubmitted biosimilars products in order to get them to the market.

They also shared that they  have set up a series of desired meetings to establish performance goals and procedures:
  • - “Type 1” meetings with sponsors trying to revive stalled drug development programs;
  • - “Type 2” meetings to discuss specific issues such as proposed study design or endpoints or questions where FDA will provide what it calls “targeted advice;”
  • - “Type 3” in-depth data review and advice meetings; and
  • - “Type 4” meetings to discuss the format and content of a biosimilar application or supplement.

According to Genetic Engineering and Biotechnology News, these objectives would be sent to Congress by January 15, 2012.

Do you think these fees and meetings will better help companies meet their goals they will have with biosimilars?

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