Endocrinology

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.
The Center for Biosimilars® recaps the top stories for the week of February 24, 2020.
This is the third Form 483 Biocon has received for the insulin plant in 3 years. 
The Center for Biosimilars® recaps the top stories for the week of February 17, 2020.
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. 
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.

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