Biosimilars/News
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).
Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb)
South Korean biosimilars firm Celltrion announced on 23 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Herzuma (trastuzumab-pkrb).
Sandoz’s rosuvastatin approved under China’s new Quality Consistency Evaluation system
Sandoz, the generics division of Novartis, announced on 9 May 2019 that it had received regulatory approval from China's National Medical Products Administration (NMPA) for its generic rosuvastatin, under the recently introduced Quality Consistency Evaluation (QCE) system.
Brazilian approval for trastuzumab follow-on biological Ontruzant
Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 27 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Ontruzant.
Trastuzumab biosimilar Ogivri approved in Canada
India-based biologicals specialist Biocon and US-based partner Mylan announced on 22 May 2019 that Health Canada had approved Mylan’s trastuzumab biosimilar Ogivri.
NeuClone to start phase I trial for ustekinumab biosimilar
Australian biologicals company NeuClone announced on 15 May 2019 that it would start a phase I clinical trial of its ustekinumab biosimilar, NeuLara, in the second half of 2019.
