Drugs

FDA Drops Peptide Transition Exclusion

FDA says that dropping the exclusion of chemically synthesized polypeptides from the March opening of most protein products that were approved as drugs, including all currently marketed insulins, to biosimilar and interchangeable competition “will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured.”

A 12/17 statement attributed to deputy commissioner for policy, legislation, and international affairs Anna Abram and CDER director Janet Woodcock said that in addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing the exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes.

The statement said that because chemically synthesized peptides are excluded from the transition, they could not come to market as biosimilar or interchangeable products, but would have to come under a different pathway. They also could not come to market through the generic drug pathway, the statement says, because the originator product will have been classified as a biologic and will not be available for copying.

“This exclusion could hurt potential competition,” Abram and Woodcock said, “because it means that if a developer were to chemically synthesize a copy of a protein product, for example, an insulin copy, the product would not be able to come to market through the abbreviated biosimilar or interchangeable pathway, but instead would have to submit a new drug application, which could be much more resource-intensive.”

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