The Center for Biosimilars® recaps the top stories for the week of January 6.
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.
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 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.
Generic drug maker Lannett Company announced positive results from the beginning of a clinical program for its proposed biosimilar insulin glargine referencing Lantus.
The FDA today released draft guidance for industry on clinical immunogenicity considerations for biosimilar insulins and interchangeable insulins.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.
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.
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.
Insulin maker Novo Nordisk has announced that, in January of 2020, it will launch authorized generics of its NovoLog (insulin aspart) and NovoLog Mix (insulin aspart protamine and insulin aspart) products. Notably, the authorized generics will become available before the March 2020 transition of insulins to regulation as biologics and biosimilars rather than drugs and generics.
Over the weekend, drug maker Biocon disclosed that it and partner Mylan have been issued a second Complete Response Letter (CRL) for their follow-on insulin glargine product referencing Lantus.

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