Biologics

Pfizer Petitions FDA for Guidance on Biosimilar Communications

Pfizer has petitioned FDA to issue a guidance document to clarify “appropriate sponsor communications about the nature and properties of biosimilar products.” The petition requests that the guidance permit “truthful and non-misleading communications by sponsors concerning the safety and effectiveness of biosimilars, including interchangeable biologics, relative to reference product(s).” FDA recently approved a BLA from Pfizer’s Hospira unit for Retacrit (epoetin alfa-epbx), the first biosimilar version of Amgen’s Epogen/Procrit (epoetin alfa) for treating anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection.

Pfizer says the guidance is needed because some “reference product sponsor-created physician- and patient-directed materials mischaracterize important elements of the biosimilar criteria and create doubt and confusion about the safety and efficacy of biosimilars. Reference product sponsors have also mischaracterized interchangeability concepts and switching to “sow doubt and confusion about biosimilars,” it says. The petition specifically cites alleged anticompetitive statements from Genentech, Amgen and Janssen Biotech.

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