Yesterday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the...

U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will take to ensure that the Orange Book (FDA's publication of Approved Drug...

On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from...

Not surprising after the European Medicines Agency (EMA) positive opinion for two biosimilars to Remicade (infliximab) in June, the first of these was authorized in September. ...

Thoughts on the U.S. Food and Drug Administration’s recently issued biosimilar guidance documents?  The time to act is now.  As described in our earlier post , FDA must provide the public...