Endocrinology

CMS announced that its Part D Senior Savings Model designed to cut insulin costs for struggling Medicare beneficiaries is attracting broad insurer participation, indicating high potential for success.  
Swedish researchers analyzing more than 10 years of data found that Omnitrope (biosimilar recombinant human growth hormone) is safe and effective in treating adult and pediatric patients with growth hormone deficiencies.
Biocon said a subsidiary’s manufacturing centers in Bengaluru, India, were cleared by European Union authorities for biosimilar production.
 
A bill designed to provide assistance to patients who cannot afford their insulin was signed into law by Minnesota Governor Tim Walz.
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.
 

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