Endocrinology

A commentary in The Lancet suggests that the new biological pathway for insulin product approval, established in March, will be insufficient to address issues insulin prices and biosimilar uptake.
 
After noting the stories of individuals with diabetes dying due to their inability to afford insulin, the Minnesota House has passed an emergency insulin bill that is expected to move rapidly through the Senate to the governor’s desk.
Russia has rebuilt its pharmaceutical industry following the demise of the former Soviet-led government, and emerging companies such as Geropharm are looking for markets abroad.
 
This week on the podcast, we’re speaking with the executive director of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC), Cate Lockhart, PharmD, PhD, about the acceptance process for biosimilars in the United States, what BBCIC is doing to help the market develop, and how the new approval pathway for biologics will affect the pace at which biosimilars come to market.
Longtime generics manufacturer Lannett is moving an insulin glargine biosimilar development plan forward and announced an upcoming meeting with the FDA. The agent would compete with the reference product Lantus.
After a number of issues raised by the FDA about plant quality, Biocon has gotten clearance for its Malaysia insulin plant and now awaits FDA marketing authorization for Semglee, its insulin glargine agent.
 
Two doctors call for interchangeability requirements for biologics to be waived for insulin products under the new regulatory pathway under the Biologics Price Competition and Innovation Act (BPCIA) of 2009.
 
As regulators work to increase competition and lower costs in the insulin market, CMS has released a new Medicare model intended to lower co-pays for insulin products to a maximum of $35.
Although biosimilar insulins are available in Europe, there are none in the United States currently, although that is slated to change.
The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.

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