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.
June 13th 2020
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.
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.
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.
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.
May 26th 2020
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.
May 19th 2020
Biocon said a subsidiary’s manufacturing centers in Bengaluru, India, were cleared by European Union authorities for biosimilar production.
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.
April 16th 2020
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.
April 15th 2020
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.
