The Center for Biosimilars Staff

February 15, 2018

Ireland’s Minister for Health, Simon Harris, announced this week that Ireland is seeking to join Belgium, the Netherlands, Luxembourg, and Austria in their BeNeLuxA Initiative, a group that negotiates price deals on pharmaceuticals directly with manufacturers.

February 14, 2018

Roche has released positive phase 2 data for its proposed novel anti–vascular endothelial growth factor and anti–angiopoietin-2 bispecific antibody, RG7716.

February 12, 2018

Some case reports have suggested that rituximab can effectively treat nephrotic syndrome, and a recent study sought to assess the safety and effectiveness of rituximab in treating patients who have steroid- and cyclosporine-resistant pediatric nephrotic syndrome.

February 11, 2018

“It is likely that the remediation by Celltrion of the issues addressed in the warning letter will result in a delayed approval of the biosimilar products by the FDA,” Teva told investors.

February 10, 2018

Novartis announced on Thursday that the FDA has approved a label update for secukinumab (Cosentyx) to include moderate to severe scalp psoriasis, a particularly challenging form of psoriasis to treat, and a condition that affects approximately half of patients with psoriasis.

February 06, 2018

The fourth-quarter and full-year 2017 earnings report from Amgen highlights the fact that biosimilars can be both a challenge and an opportunity for drug makers whose innovator products face biosimilar competition and who develop biosimilar products of their own.

January 31, 2018

The early weeks of 2018 held substantial developments for oncology biosimilars in the United States and around the world, with new products on the horizon and evolving challenges in bringing these drugs to the marketplace.

January 30, 2018

Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, is expected to post its first profits in 2018, according to estimates made by a Republic of a Korea-based securities firm.

January 28, 2018

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.

January 27, 2018

In total, income from Biocon’s biologics division was down 15% for the quarter (compared with the same period for the company’s prior financial year), despite the fact that product sales grew 16% year over year, with increased sales of insulins and biosimilar antibodies. The company’s total net profits declined by 46%.