Celltrion receives EMA marketing authorisation for Remsima SC, the first subcutaneously-administered option for delivery of infliximab, a treatment for rheumatoid arthritis.
Lonza’s facility in Singapore will provide Celltrion with the drug substance product to meet demand for the latter’s Remsima biosimilar in the European and US market.
Celltrion has partnered with Nan Fung Group to create Vcell Healthcare, which will manufacture and commercialize three of Celltrion’s biosimilar products in China.
Celltrion plans to invest across its pharmaceutical business up to 2030, creating an estimated 110,000 new jobs in the process and launching 20 products.
Celltrion Healthcare’s head of medical and marketing outlines how the US biosimilar market is evolving and how manufacturing efficiency could become a key distinguisher from competitors.
The US regulator has validated Celltrion and Teva’s biosimilar version of Roche’s Herceptin, marking the partnership’s second approval in as many months.
Celltrion and Teva have overcome regulatory hurdles to secure approval for Truxima in the US, a biosimilar to non-Hodgkin’s lymphoma treatment, Rituxan.
Regulatory setbacks at Teva’s CMO facility in Korea have not halted the regulatory progression of preventive migraine treatment Ajovy, which has received US FDA approval.
