The Center for Biosimilars Staff

October 26, 2017

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.

October 25, 2017

Legal challenges to a recent jury verdict in Amgen v Hospira continue, with both parties in the case filing briefs asking for new trials over aspects of the ruling.

October 24, 2017

In its third-quarter earnings report, Swiss drug maker Novartis announced that its net sales have risen by 2%, and net income by 10%, compared to the same period last year. The company credited its biosimilars business as a key factor in its growth.

October 23, 2017

The Australian Medical Association has issued a comment to the nation’s government concerning new proposals aimed at increasing biosimilar uptake in Australia.

October 22, 2017

Data from 5 studies presented at the European Society for Medical Oncology (ESMO) 2017 meeting highlighted the progress of biosimilar trastuzumab candidates.

October 21, 2017

In addition to challenges related to reliable power, connectivity, transportation, and clean water, Puerto Rico

October 19, 2017

SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.

October 18, 2017

Nichi-Iko has disclosed that it is currently engaged in consultations with the FDA concerning the demonstration of interchangeability of its proposed biosimilar with the reference Remicade.

October 18, 2017

On Monday, a Federal Circuit judge invalidated Allergan’s patents for its dry-eye drug, Restasis, on the basis of obviousness. He also ordered the joinder of the Saint Regis Mohawk Tribe with Allergan as a co-plaintiff in the action against drug maker Teva, which seeks to develop a follow-on version of the drug.

October 17, 2017

The Senate’s Health, Education, Labor and Pensions (HELP) Committee today heard testimony from pharmaceutical manufacturers and the supply chain in a full committee hearing titled “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay.”