10:50 AM
Jun 29, 2018
 |  BioCentury  |  Regulation

Biosimilars do-over

Why FDA withdrew draft biosimilar guidance

As part of an initiative to stimulate biosimilar competition, FDA is planning a do-over of draft guidance on statistical methods for demonstrating biosimilarity to a reference product.

The agency announced on June 21 it was withdrawing a draft guidance on statistical approaches for evaluating analytical similarities between a proposed biosimilar and its reference product. The withdrawal will be followed this month by an FDA biosimilars action plan that is intended to reduce the cost and uncertainty of developing products that compete with some of the most expensive medicines.

Details of the plan have not been announced. Biosimilars developers hope it will ease restrictions on the use of foreign originator biologics and facilitate development of interchangeable biologics.

Although controversies over standards for reviewing biosimilars applications are very technical, they are receiving high-level attention at FDA because the ways they are handled could have substantial public policy and political implications.

“FDA could step away from highly prescriptive guidance on the use of statistical tools because it turns out there is no one-size-fits-all approach.”

Martin Schiestl, Sandoz

Robust biosimilar competition represents one of the Trump administration’s best bets for delivering on promises to dramatically lower drug prices.

By revamping the draft guidance, FDA is signaling its intention to move aggressively to do what it can to facilitate biosimilars development.

More than eight years after the March 2010 enactment of the Biologics Price Competition and Innovation Act of 2009, the biologics pathway hasn’t delivered on promises of dramatic cost-savings. Three of the 11 biosimilars FDA has approved are on the market.

From March 2010 to June 1, 12 companies publicly announced submission of 23 biosimilar applications to FDA.

According to a 2015 analysis by the Boston Consulting Group, 51 biologics were set to lose exclusivity over 2014-20. As of June 1, sponsors and FDA...

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