February 21st 2020
The Center for Biosimilars® recaps the top stories for the week of February 17, 2020.
February 17th 2020
By Skylar Jeremias
Which Medicaid plans benefit the most from the current drug rebate structure and are incentivized to prescribe branded prescriptions? Researchers used the issue of follow-on insulin glargine as well as glatiramer acetate to find out.
January 29th 2020
By The Center for Biosimilars Staff
The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
January 11th 2020
The Center for Biosimilars® recaps the top stories for the week of January 6.
January 7th 2020
By Allison Inserro
Novo Nordisk said 3 measures to make insulin more affordable are now available, and it also announced that the FDA expanded use of its fast-acting mealtime insulin to children as young as 2.
December 18th 2019
The pan-Canadian Pharmaceutical Alliance engaged the Canadian Agency for Drugs and Technologies in Health to lead a multiphase stakeholder consultation process to encourage biosimilar uptake.
December 11th 2019
Sanofi will retain its insulin business, but will otherwise stop research and development in diabetes and cardiovascular drugs in order to focus on cancer immunotherapies and its biologic for asthma and allergies.
December 4th 2019
Generic drug maker Lannett Company announced positive results from the beginning of a clinical program for its proposed biosimilar insulin glargine referencing Lantus.
November 25th 2019
By Kelly Davio
The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins. The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.
November 6th 2019
Sanofi released phase 3 results this week for its long-acting insulin glargine (Toujeo) when used in pediatric patients with type 1 diabetes aged 6 to 17.
