Diabetes

Policy Differences Among European Nations Affect Biosimilar Uptake

January 5th 2018

By Kelly Davio

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.

Sanofi Sues Mylan Over Infringement of Lantus Patents

October 26th 2017

By The Center for Biosimilars Staff

Article

This week, drug maker Sanofi filed a patent infringement suit against Mylan in a New Jersey district court. Sanofi’s suit alleges that Mylan has infringed on 18 patents for its originator insulin glargine, Lantus.

Biosimilars and the Nocebo Effect

October 18th 2017

By Jackie Syrop

Article

Switching patients from originator biologics to biosimilars is associated with the potential for a “nocebo” effect, a phenomenon that occurs when a patient’s negative expectation causes a treatment to have a more negative effect than it otherwise would—essentially, the opposite of the placebo effect.

Industry Groups Sue Nevada Over "Unprecedented" Drug Price Transparency Law

September 18th 2017

By The Center for Biosimilars Staff

Article

This month, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), trade groups representing the biopharmaceutical and biotechnology industries, announced that they are challenging Nevada’s Senate Bill (SB) 539 in district court litigation.

EAHP Position on Biosimilars Contrasts With US Regulation on Naming, Interchangeability

September 2nd 2017

By The Center for Biosimilars Staff

Article

The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.

FDA Grants Tentative Approval to Follow-On Insulin Lispro, Admelog

September 1st 2017

By Kelly Davio

Article

The FDA has granted tentative approval of Sanofi’s follow-on insulin lispro injection, Admelog. Referenced on the originator product, Humalog, Sanofi’s insulin lispro is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes.