Biologics

Sandoz Given ‘Complete Response’ on Neulasta Biosimilar

Novartis says its Sandoz drug unit has received a complete response letter from FDA for a biosimilar pegfilgrastim candidate (Amgen’s Neulasta). “We are working with the agency to address remaining questions,” the company briefly said in a 7/19 financial report.

Sandoz reported 11/2015 that FDA had accepted its aBLA for a biosimilar version of Amgen’s Neulasta. The company said at the time it believed that the totality of evidence in its submission, including three pivotal clinical studies, will demonstrate that the proposed biosimilar is “highly similar to the reference product.” Sandoz also said it was seeking the same indication as for the reference product—to help reduce the chance of infection due to a low white blood cell count, in patients with non-myeloid cancer who receive chemotherapy that can cause fever and a low blood cell count.

Last month, Amgen filed a Biologics Price Competition and Innovation Act (BPCIA) suit against Sandoz for allegedly infringing two key Neulasta patents. The complaint alleges that if FDA approves the aBLA, Sandoz will inevitably infringe the patent that covers a method for purifying proteins used in manufacturing Neulasta by making, using, offering to sell, or selling an infringing product within the U.S. Amgen is asking for damages and an injunction against Sandoz. The court has granted the parties’ request to relate this suit with an earlier one that covered the BPCIA patent dance and commercial marketing notice provisions. The effect of relating the cases is that the same judge will hear both cases that have been filed in a California federal court.

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