Drugs

Coherus Biosciences Wants Apotex Neulasta Petition Denied

Coherus Biosciences says FDA must deny an Apotex petition that contains a misunderstanding about the role of clinical studies in a biosimilar application submitted under the regulatory pathway created by the Biologics Price Competition and Innovation Act. The Coherus response says that “Apotex’ misunderstanding has led the company to erroneously conclude that a specific type of clinical study is or is not required for regulatory approval of a biosimilar application." Coherus requests that FDA correct Apotex’ mistaken conclusion so that other biosimilar sponsors are not misled into believing that additional unnecessary, and therefore unethical, clinical studies must be undertaken to obtain licensure of a biosimilar.”

“The goal overall is that any biosimilar sponsor compile, after an expedited development program, a data package that is scientifically well-founded and that provides evidence that the biosimilar will behave clinically in the same manner as its reference product,” Coherus says. “This can be achieved even though the data package is not expected to contain clinical trials in every indication or every population in which the reference product is in use. This point is amply demonstrated by the five biosimilars FDA has licensed. The concept of extrapolation is founded on the exquisite molecular match possible through the careful use of modern analytical methods. Such a match is essential to the development of biosimilars, and ultimately to the development of interchangeable biologics. It is also data that are privileged to each sponsor and on the basis of which each clinical confirmatory program will have been individually negotiated with 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

Read more

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