Drugs

House Hearing on FDA Biosimilar Program

The House Energy and Commerce Subcommittee on Health has scheduled a 2/4 hearing on “Examining Implementation of the Biologics Price Competition and Innovation Act.” The 2010 law established a new abbreviated approval pathway at FDA for biological products determined to be “biosimilar” or “interchangeable” with a previously FDA-licensed biologic product. No hearing witnesses have been announced to date.

Presumably, the subcommittee will examine FDA’s guidance issuance and the 2015 approval of the first biosimilar product — Sandoz’s Zarxio (filgrastim-sndz), which is a copy of Amgen’s Neupogen (filgrastim). Late last year, CDER director Janet Woodcock said too much is being made of biosimilar interchangeability and pharmacy substitution (see story) as FDA moves through its review and approval of the first biosimilars in the U.S. She acknowledged that would-be biosimilar product makers are pursuing the kind of studies that are necessary to compare switching, and a draft guidance on interchangeability is in the works. However, the majority of products coming down the pipeline are infusion-related, or where patients are started on therapy in the clinic. “You don't go up to the pharmacy and ask for your infusion,” she scoffed.

For now, Woodcock said the main consideration for biosimilars, or any drug approval, is that “it is always a prediction and we have to see what happens out in the real world... So we have to be able to know if a biosimilar is causing problems that we did not anticipate, or what if the innovator product is causing problems and do we want to remove all the drugs from the market because the innovator is having a manufacturing glitch that is causing harm? So we need a way to track and identify those so that we know whether our predictions are right, and so we can assure the public that we are on the case.”

According to a just posted CDER guidance agenda, the agency plans to publish the following biosimilar documents this year:Considerations in Demonstrating Interchangeability With a Reference ProductLabeling for Biosimilar ProductsStatistical Approaches to Evaluation of Analytical Similarity Data to Support a Demonstration of Biosimilarity

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome