Mylan calls for streamlined interchangeable insulin pathway

A streamlined approach to interchangeable insulins will help to eliminate burdensome requirements that are hindering the therapies’ development, according to a Mylan executive.

Abhijit Barve, head of global clinical research at Mylan N.V. (NASDAQ:MYL), said that a single immunogenicity study with relatively few patients is sufficient to demonstrate interchangeability as opposed to two trials outlined in FDA biosimilars guidance published in December. He spoke at a May 13 FDA workshop on the development of biosimilar and interchangeable insulins (see "FDA Biosimilars Policies will Bring Interchangeable Insulin to Market")...