Diabetes

Mylan and Biocon's Biosimilar Insulin Glargine Authorized in European Union and Australia

March 28th 2018

By Kelly Davio

Article

The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. Mylan and Biocon say that they plans to launch the product in various markets in Europe in the second half of 2018, and in Australia “later this year.”

Mylan and Biocon's Follow-On Insulin Glargine Recommended for European Approval

January 28th 2018

By The Center for Biosimilars Staff

Article

On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on and recommended a marketing authorization for Mylan and Biocon’s Semglee, an insulin glargine follow-on that will be available in the European Union as a solution for injection for patients with diabetes.

Similar Safety, Efficacy, Immunogenicity Shown for Admelog and Reference Humalog

January 23rd 2018

By Jackie Syrop

Article

SAR342434, or Admelog, a follow-on of insulin lispro (Humalog), showed similar efficacy, safety, and immunogenicity to its reference in patients with type 2 diabetes who also used insulin glargine (Lantus) as basal insulin, according to the results of the SORELLA-2 study, published in the January 2018 issue of Diabetes Technology & Therapeutics.

Can Anti-TNF Therapies Treat Insulin Resistance and Type 2 Diabetes?

January 19th 2018

By Jackie Syrop

Article

Antagonism of tumor necrosis factor-alpha (TNF-alpha) may be a good treatment strategy to counter the deleterious effects of TNF-alpha on the development of insulin resistance and the pathogenesis of type 2 diabetes.

Eye on Pharma: NeuClone Developing Denosumab Biosimilar

January 8th 2018

By Kelly Davio

Article

Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva).

Policy Differences Among European Nations Affect Biosimilar Uptake

January 5th 2018

By Kelly Davio

Article

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.

Mylan Announces IPR Proceedings Against Sanofi's Lantus Patents

December 19th 2017

By Kelly Davio

Article

Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus.

FDA Grants Final Approval to First Short-Acting Follow-on Insulin, Admelog

December 12th 2017

By Kelly Davio

Article

The FDA has granted final approval to the first short-acting follow-on insulin product, Sanofi’s Admelog (insulin lispro injection). Admelog is indicated to improve insulin control in blood sugar levels in adults and children aged 3 years and older who have type 1 diabetes and in adults who have type 2 diabetes.

Novo Nordisk, Sanofi Announce Positive Data In Heated Competition for Insulin Market Share

December 6th 2017

By Kelly Davio

Article

Novo Nordisk has announced new data on its development of a next-generation insulin that could help the company stave off biosimilar and follow-on insulin competition. Meanwhile, Sanofi announced that its own insulin met its main objective in a head-to-head study versus Novo Nordisk’s product.

Lawsuit Alleges Eli Lilly Used Kickbacks to Increase Use of Its Insulin Products

November 21st 2017

By Jackie Syrop

Article

A recently unsealed lawsuit alleges that drug maker Eli Lilly illegally worked with Healthstar Communications and VMS Biomarketing to provide free nursing services to induce healthcare providers to prescribe the drug maker’s insulin products Humalog and Humulin.