Diabetes

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.

Insulin Degludec May Be More Cost Effective Than Insulin Glargine or Its Biosimilar

September 1st 2017

By Jackie Syrop

Article

Insulin degludec (Tresiba) is a cost-effective alternative to insulin glargine U100 (Lantus) for patients with diabetes, and it is also likely to be more cost-effective than 2 newly marketed basal insulin analogues, including a biosimilar.

Biosimilar Endocrinology Roundup: August

August 28th 2017

By Kelly Davio

Article

August saw notable developments in the market for insulins in the world of endocrinology biosimilars and follow-ons: new studies showed similarity between a challenger to branded insulin glargine; price competition gained momentum; and patients, providers, and state governments signaled an urgent need for diabetes drug prices to drop.

2 Studies Show Similar PK, PD for MK-1293 and Originator Insulin Glargine

August 23rd 2017

By The Center for Biosimilars Staff

Article

A new paper, accepted for publication in Diabetes, Obesity and Metabolism, describes 2 recent studies that demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) similarity between MK-1293, an insulin glargine follow-on being developed by Merck (who funded the studies), and the originator insulin glargine (Lantus).

Infographic: The Diabetes Pipeline

August 20th 2017

By The Center for Biosimilars Staff

Article

A recent report examined the products and projects targeting diabetes and diabetes-related complications are in the current biopharmaceutical pipeline. Our infographic details the key findings.

State Efforts Lead the Fight Against High Drug Prices

August 17th 2017

By Kelly Davio

Article

While the FDA appears to be taking a more active role in leveraging its position to influence drug prices, the majority of efforts to bring down pharmaceutical costs are taking place at the state level.