Drugs

Regulators Look for Biosimilar ‘Scientific Alignment’: FDAer

CDER Office of New Drugs associate director for therapeutic biologics Leah Christl says that her agency and other major regulators are working toward attaining scientific alignment on biosimilar regulation rather than harmonization. Speaking at the 2016 DIA biosimilars conference, Christl said FDA “avoids using the word harmonization, because harmonization often connotes shared documents and guidelines.” She said that regulators from the European Medicines Agency (EMA), Health Canada, and Japan’s Pharmaceutical and Medical Devices Agency have been working with FDA in a biosimilars cluster to tackle and align the scientific knowledge surrounding biosimilar reviews.

Such scientific alignment is also exemplified, she said, through a program between FDA and the EMA to provide parallel scientific advice. She said FDA ultimately wants the parallel scientific advice meeting to be an opportunity for regulators to meet and discuss their differences in opinion on a specific issue within the development program. Both agencies would individually discuss the package and then meet to discuss prior to a joint meeting with the sponsor, she said. It also could be a forum in which companies could identify key hurdles within a development program and discuss with both FDA and EMA regulators to move past the challenges.

Christl noted that companies interested in marketing biosimilars globally want to maximize the data they have. One of the biggest mistakes a biosimilar company can make, she said, is not envisioning the future of its candidates in the global market. Though a company might not be planning to have its biosimilar approved in a certain global region for several years, Christl said it should still establish a relationship with that region’s regulatory agency early in the development process. She cautioned that companies that don’t continuously integrate advice from various regulators throughout development risk having to provide additional data when they finally approach a regulator for approval.

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