Drugs

Ways to Ease Drug Interchangeability Claims: Avalere

Avalere Health says the FDA 1/2017 draft guidance on interchangeability for biologics is “cautious and demanding,” and meeting it would be so costly that it would be difficult for biosimilar manufacturers to achieve a return on their investment. It says the White House Council of Economic Advisors in a policy report on lowering drug prices has called on FDA to finalize the draft guidance in a way that is “relatively easy and inexpensive to adhere to.”

In an online Insight, Avalere identifies three ways it says FDA could facilitate applications and approvals for interchangeable biosimilars:

make reference products more readily available for conducting any necessary switching studies such as by publicly rebuking branded drug manufacturers and pharmaceutical supply chain intermediaries that restrict access to drug samples;
apply appropriate scientific reasoning and clear international guidance to choice of reference product for biosimilar development; and

· encourage efficient development and approval of all biologics and not just biosimilars.

“The science is the best it has ever been,” Avalere concludes. “2018 looks to be the year when FDA will begin to update its regulatory requirements to better leverage that science and their own scientific expertise and experience for the development of more treatment options, including originator biologics, biosimilars, and interchangeable biologics. This will enable greater access and affordability for patients through competition, a goal that commissioner Scott Gottlieb has articulated for the agency.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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