Celltrion has announced plans to proceed to Phase I clinical trials of its Prolia/Xgeva (denosumab) biosimilar candidate. The company is also working on biosimilar versions of bevacizumab, omalizumab and ustekinumab for both Europe and the US.
Celltrion has announced plans to begin Phase I clinical trials of its denosumab biosimilar candidate, CT-P41, in September 2020. Celltrion’s product referencing Amgen’s Prolia/Xgeva will be tested for safety in healthy participants.
Aiming to complete the Phase I trial of testing CT-P41 in the first half of 2021, Celltrion has further planned...
Denosumab biosimilar ranks are filling up in Europe as approvals flood in. Yet, little is known about the launch dates.
Shanghai Henlius Biotech has received EMA GMP certification for its HLX14 and HLX11 biosimilar production lines, paving the way for faster market entry in the EU and reinforcing its global manufacturing credentials.
Alvotech has acquired long-time partner Ivers-Lee to expand its in-house capacity for assembly and packaging ahead of key planned biosimilar launches in 2025, strengthening operational control and supporting global growth.
At Medicines for Europe’s annual conference in Brussels, executives from Polpharma Biologics and Gedeon Richter spoke about the challenges in finding biosimilars manufacturing staff with the right backgrounds – and how they are looking to other industries to bridge the skills gap.
