The Center for Biosimilars Staff

July 04, 2019

The investigators found that the biosimilar and the reference in combination with a subdomain II–targeting antibody had similar in vitro inhibition rates for HER2 and HER3 heterodimerization.

July 03, 2019

The European Commission approved ravulizumab (Ultomiris) for adults with paroxysmal nocturnal hemoglobinuria.

July 03, 2019

Under the approach used by Kaiser Permanente, say the authors, in which oncologists have salaried incomes and are not reimbursed on a relationship to drug price, far higher generic uptake has been observed.

July 01, 2019

Amgen says it is withdrawing its European application for ABP 710, its biosimilar infliximab (referencing Remicade).

July 01, 2019

Mundipharma, a network of independent companies that operates in 120 countries worldwide and distributes a number of biosimilars in the European Union, has inked a deal with Budapest-based Egis Pharmaceuticals to distribute its biosimilar pegfilgrastim, Pelmeg, in 4 Eastern European markets: Hungary, Romania, Lithuania, and Latvia.

June 29, 2019

The European Specialist Nurses Organisation has launched 7 new translations of its guide to the management of switches between reference biologics and biosimilars.

June 28, 2019

Alexion Pharmaceuticals’ brand-name eculizumab (Soliris) gained its fourth approval, this time for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

June 27, 2019

The FDA today announced a proposed rule that would amend regulations concerning the use of master files for biologics. According to the FDA, this rule is necessary to avoid any disruption to products that will transition from regulation as drugs to regulation as biologics in 2020.

June 27, 2019

Eli Lilly and Company, together with partner Innovent Biologics, announced today that China’s National Medical Products Administration will review its application for IBI301, a proposed rituximab biosimilar referencing MabThera and Rituxan.

June 24, 2019

China-based drug maker Henlius has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for a trastuzumab biosimilar, HLX02, referencing Herceptin.