The Center for Biosimilars Staff

June 22, 2019

Drug maker Alexion, developer of the rare disease drug eculizumab (Soliris), announced Friday that the FDA has accepted for priority review its long-acting C5 complement inhibitor, ravulizumab (Ultomiris), which offers less frequent administration than eculizumab.

June 19, 2019

Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.

June 18, 2019

Amgen is developing a biosimilar of the drug, ABP 959, and during last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers reported on findings from a phase 1 trial of the proposed product.

June 17, 2019

Irish hospitals will be offered a €500 (US $561) incentive for each patient switched from brand-name Humira or Enbrel to a biosimilar option.

June 16, 2019

During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, researchers from the University of Manchester reported on their findings regarding patients with rheumatoid arthritis (RA) involved in the BSRBR-RA study who had switched from reference infliximab or reference etanercept to biosimilars.

June 15, 2019

Given the cost of the brand-name drug, there is interest among providers, particularly in contexts with limited resources, in using a biosimilar rituximab to treat pemphigus, and recently, 2 studies reported on the use of biosimilar rituximab in treating this disease.

June 14, 2019

Researchers say they were able to create an “antibody lock” that makes infliximab more selective in its activity, making it safer and more effective.

June 13, 2019

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

June 13, 2019

Drug maker Genentech, developer of the brand-name rituximab, Rituxan, has announced that the FDA has accepted a supplemental Biologics License Application for the drug’s first proposed pediatric indication: 2 rare forms of vasculitis.

June 12, 2019

The American Medical Association (AMA), which is holding its annual meeting this week in Chicago, Illinois, has issued a call for intensified oversight of the pharmacy benefit manager (PBM) industry.