Diabetes

Follow-on Insulin Glargine, Generic Glatiramer Illustrate Medicaid Drug Rebate Issue, Study Says

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.

Vizient Says It Supports FDA Plan for Insulin Biosimilars, Interchangeable Insulins

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.

The Top 5 Biosimilars Articles for the Week of January 6

January 11th 2020

The Center for Biosimilars® recaps the top stories for the week of January 6.

Novo Nordisk Launches Authorized Generic Insulins, Gets FDA Approval for Fast-Acting Insulin in Pediatric Population

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.

Canadian Organizations Gather Stakeholders to Stimulate Biosimilar Acceptance

December 18th 2019

By The Center for Biosimilars Staff

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.

Sanofi to End R&D on Diabetes, Cardiovascular Drugs

December 11th 2019

By Allison Inserro

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.

Lannett Announces Positive Results for Biosimilar Insulin Glargine

December 4th 2019

By The Center for Biosimilars Staff

Generic drug maker Lannett Company announced positive results from the beginning of a clinical program for its proposed biosimilar insulin glargine referencing Lantus.

FDA Releases Draft Guidance on Insulin Biosimilars, Interchangeable Insulins

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The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.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.

With Lantus Under Pressure From Follow-on, Sanofi Releases Phase 3 Results for Toujeo in Pediatric Population

November 6th 2019

By Allison Inserro

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.

Eye on Pharma: Pfenex Reports Results of Human Factors Study for Follow-on Teriparatide

October 19th 2019

By The Center for Biosimilars Staff

Drug maker Pfenex announced this week that it has completed its comparative use human factors study for its follow-on teriparatide product, PF708, referencing the osteoporosis drug Forteo.