Kelly Davio

August 28, 2017

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.

August 26, 2017

Roche’s sales of ranibizumab (Lucentis), already depleted by competition from such products as afilbercept (Eylea), face upcoming erosion from biosimilar competition.

August 25, 2017

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira.

August 24, 2017

The FDA has signed a new confidentiality agreement with the European Commission (EC) and the European Medicines Agency (EMA). The agreement will allow the FDA to share with the EC and EMA nonpublic, commercially confidential information (including trade secrets) related to inspections.

August 23, 2017

A study published in the British Journal of Clinical Pharmacology demonstrated the bioequivalence of GP2015, a biosimilar etanercept treatment (Sandoz’s Erelzi), when delivered with an auto-injector and when delivered with pre-filled syringe in patients across a variety of body weights.

August 22, 2017

Drug maker Alexion has announced 3 new US patents for its eculizumab (Soliris), a first-in-class monoclonal antibody that specifically binds to the complement protein C5. Additionally, the drug gained the European Commission’s approval for the treatment of refractory generalized myasthenia gravis.

August 21, 2017

Febrile neutropenia (FN) is among the most common complications of chemotherapy, and a recent post-marketing, multi-center, real-world, non-interventional, epidemiological study sought to examine the use, safety, and efficacy of biosimilar filgrastim in the primary and secondary prevention of FN.

August 18, 2017

A recent paper, published in BioDrugs, argues that, in biosimilar development, bridging studies between locally licensed and internationally licensed reference biologics may be unnecessary.

August 17, 2017

Yesterday, Biocon withdrew from the European Medicines Agency (EMA) its applications for the authorization of biosimilar trastuzumab and pegfilgrastim.

August 17, 2017

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.