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As part of an initiative to stimulate biosimilar competition, FDA is planning a do-over of draft guidance on statistical methods for demonstrating biosimilarity to a reference product.

The agency announced on June 21 it was withdrawing a draft guidance on statistical approaches for evaluating analytical similarities between a proposed biosimilar and its reference product.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

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