Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s Lantus (insulin glargine).

Ushering in a new era for the U.S. biosimilar marketplace, the FDA, on July 28, approved its first interchangeable biosimilar, which also will be the first to bring biosimilar competition to the U.S. insulin space. The honor went to Viatris Inc.’s Semglee, which the FDA recognized as both biosimilar to and interchangeable with Sanofi SA’s blockbuster drug Lantus (insulin glargine), a long-acting insulin analogue.

Polarityte Inc.’s Skinte product met primary and secondary endpoints in a randomized clinical trial evaluating healing of diabetic foot ulcers. Skinte is a human cellular and tissue-based product made from a patient’s own skin. Results from the trial and data from the product’s use from 2017 to 2021 during a period of enforcement discretion by the FDA were used by the company in its filing earlier this week of an investigational new drug application for Skinte.

Following November’s equity investment that brought it a 14% ownership in Protomer Technologies Inc., Eli Lilly and Co. has acquired the privately held company engineering protein and peptide therapeutics that sense molecular activators. If development and commercial milestones are met, the deal could be worth more than $1 billion.

Scientists have found a rare genetic variant carried by 1 in 3,000 people, which they say has a larger impact on the risk of developing type 2 diabetes than any other genetic defect identified to date.

Despite an FDA advisory committee’s narrow ruling that Provention Bio Inc.’s teplizumab has benefits that outweigh the risks in treating diabetes, the agency sent the company a complete response letter (CRL) regarding the diabetes therapy’s priority BLA. The CRL came the evening of July 2, Provention said, the PDUFA date that had been set months before.

Poxel SA and Sumitomo Dainippon Pharma Co. Ltd. said their first-in-class drug, Twymeeg (imeglimin hydrochloride), won its first approval in Japan, where it could change the treatment regimen for type 2 diabetes.

PARIS – Aptargroup Inc. is negotiating to buy Voluntis SA in a move that would complement its existing digital solutions portfolio and expand services to address multiple conditions and chronic diseases. "By being part of Aptar, we will be able to pursue a common ambition aimed at providing a complete digital health platform combining connected devices and digital therapeutics," Pierre Leurent, CEO and co-founder of Voluntis, told BioWorld.