Diabetes

FDA Approves Eli Lilly Insulin Lispro Formulation

June 18th 2020

By Tony Hagen

Eli Lilly gets FDA approval for a new formulation of insulin lispro and offers it at the out-of-pocket cap of $35 for a monthly supply for patients with or without insurance.

It's a New Set of Rules for Insulin Products Under 351(k)

June 15th 2020

By Tony Hagen

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.

Semglee Insulin Gains Automatic Approval under BPCIA

June 13th 2020

By Tony Hagen

In gaining FDA approval, the insulin glargine product Semglee receives automatic status as a biologic under the Biologics Price Competition and Innovation Act (BPCIA), although it was approved as a 505(b)(2) product under the Food Drug and Cosmetic Act. Semglee becomes the first insulin glargine under the 351(a) pathway.

England Missed Out on Biosimilar Insulin Glargine Savings, Study Says

June 13th 2020

By Tony Hagen

Investigators said the English health care system has realized only a sliver of the potential savings potential from biosimilar insulin glargine and that uptake is widely uneven across health care centers.

Lannett Is Confident After FDA Insulin Glargine Meeting

June 12th 2020

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

CMS Insulin Savings Model Shows Early Success

May 27th 2020

By Skylar Jeremias

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.

Sandoz' Omnitrope Supported by Long-Range Swedish Study

May 26th 2020

By Skylar Jeremias

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 Gains EU Manufacturing Certification for India Plants

May 19th 2020

By Tony Hagen

Biocon said a subsidiary’s manufacturing centers in Bengaluru, India, were cleared by European Union authorities for biosimilar production.

Minnesota Governor Signs Emergency Insulin Bill

April 17th 2020

By The Center for Biosimilars

A bill designed to provide assistance to patients who cannot afford their insulin was signed into law by Minnesota Governor Tim Walz.

BPCIA Transition Can't Fix Insulin Market Alone

April 16th 2020

By Skylar Jeremias

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.