Biosimilars/News
EMA accepts first application for Chinese-made biosimilar HLX02
China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines Agency (EMA).
Rituximab copy biological accepted for review in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.
FDA approves rituximab biosimilar Ruxience
US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar (PF 05280586).
Lannett starts phase I trial for insulin glargine biosimilar in South Africa
US generics maker Lannett Company (Lannett) announced on 5 June 2019 that it had started a phase I clinical trial of its candidate insulin glargine biosimilar.
EMA accepts application for bevacizumab biosimilar from Samsung Bioepis
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 19 July 2019 that the application for approval for its proposed bevacizumab biosimilar SB8 has been accepted for review by the European Medicines Agency (EMA).
Sandoz to start phase III trial for denosumab biosimilar
Sandoz, the generics division of Novartis, is planning to start a phase III trial for its candidate denosumab biosimilar GP2411 in patients with post-menopausal osteoporosis in collaboration with Germany-based biosimilars maker Hexal.
FDA approves bevacizumab biosimilar Zirabev
US-based pharma giant Pfizer announced on 28 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its bevacizumab biosimilar Zirabev (PF-06439535).
FDA approves trastuzumab biosimilar Kanjinti
US-based pharma giant Amgen and Netherlands-based Allergan announced on 13 June 2019 that it had received approval from the US Food and Drug Administration (FDA) for its trastuzumab biosimilar Kanjinti (ABP 980).
Alteogen gains approval to start aflibercept biosimilar trial in Korea
South Korean biologicals company Alteogen announced on 22 May 2019 that it had gained approval from the Korean Ministry of Food and Drug Safety (MFDS) to initiate a clinical trial for its aflibercept biosimilar, ALT‑L9.
Trastuzumab biosimilar from Prestige accepted for review by EMA
Singapore-based Prestige BioPharma (Prestige) announced on 28 May 2019 that the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) had been accepted by the European Medicines Agency (EMA).
