The Center for Biosimilars Staff

November 13, 2017

Boehringer Ingelheim (BI) announced today that its adalimumab biosimilar, Cyltezo, has been granted marketing authorization by the European Commission to treat multiple rheumatic diseases after having received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use in September 2017.

November 11, 2017

Samsung Bioepis announced this week that it has gained regulatory approval in the Republic of Korea for its trastuzumab biosimilar, SB3.

November 09, 2017

“If the patient doesn’t have better access, you don’t need a biosimilar," argues Roy Fleischmann, MD.

November 08, 2017

At this week’s American College of Rheumatology 2017 Annual Meeting, Boehringer Ingelheim (BI) announced 1-year data from the VOLTAIRE-RA trial, which showed that BI’s newly approved adalimumab biosimilar (Cyltezo) showed no clinically meaningful differences in safety, efficacy, or immunogenicity from the reference adalimumab (Humira) in patients who had moderate to severe rheumatoid arthritis (RA).

November 05, 2017

Two recent studies have provided long-term data on the safety and efficacy of switching patients from Remicade to its biosimilars.

November 04, 2017

Drug maker Celltrion has entered into a contract manufacturing organization agreement with Baxter BioPharma Solutions for the production of its biosimilars in the United States.

November 02, 2017

The United Food and Commercial Workers Local 1500 Welfare Fund has filed an antitrust lawsuit against Johnson and Johnson in Pennsylvania’s Eastern District Court. The suit takes aim at the drug maker over its blockbuster innovator infliximab, Remicade.

November 01, 2017

The FDA has announced that the agency will recognize 8 European regulatory agencies as capable of conducing manufacturing facilities inspections that will meet FDA requirements. The agencies named are those of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom.

October 31, 2017

The high cost of prescription drugs, the need for more competition in the marketplace, and the potential for biosimilars to provide substantial savings were key topics among biosimilars stakeholders in the month of October.

October 29, 2017

A recent study found that injectable anticancer drugs steadily increase in price, even after competition enters the market.