As part of its BsUFA II commitments, the FDA released a draft guidance this week on designing and evaluating comparative analytical studies, using a stepwise approach, to support a demonstration of biosimilarity to a reference biologic. The draft, “Development of therapeutic protein biosimilars: Comparative analytical assessment and other quality considerations,” revises a final guidance published April 30, 2015, that advised on quality considerations in demonstrating biosimilarity. The new draft updates recommendations for collecting and analyzing comparative analytical similarity data and discusses aspects of the chemistry, manufacturing and controls portion of a biosimilar marketing application. Comments on the draft are due by July 21.

CMS delayed its final National Coverage Determination on CAR T-cell therapy for cancer, saying the “decision is forthcoming.” Under its proposed decision, released in February, Medicare contractors would have to cover a therapy nationwide when it is offered in a CMS-approved registry or clinical study in which patients are monitored for at least two years post-treatment. Evidence from the registries and studies would be used to identify the types of patients who benefit from the therapy, informing future coverage decisions. Until a national coverage policy is finalized, local Medicare administrative contractors have discretion over whether to pay for FDA-approved CAR T-cell therapies, such as Novartis AG’s Kymriah (tisagenlecleucel) and Gilead Sciences Inc.’s Yescarta (axicabtagene ciloleucel).