Biosimilars/News
Canada approves infliximab biosimilar Remsima SC
Canada’s drug regulator, Health Canada, has approved the infliximab biosimilar Remsima SC for the treatment of autoimmune diseases.
Innovent starts phase II trial for ipilimumab copy biological
China-based Innovent Biologics (Innovent) announced on 11 December 2020 that the first patient had been successfully enrolled and dosed in the randomized, double-blind, phase II multicentre clinical trial (NCT04590599) evaluating its ipilimumab copy biological (IBI310) in combination with TYVYT (sintilimab) for the treatment of patients with second-line or above advanced cervical cancer.
EMA recommends approval of adalimumab biosimilar Yuflyma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting of marketing authorization for an adalimumab biosimilar.
China extends indications for adalimumab and bevacizumab copy biologicals
Chinese biopharmaceutical firm Innovent Biologics (Innovent) announced that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved new indications for its adalimumab and bevacizumab copy biologicals.
Canada approves three teriparatide biosimilars in 2020
Canada’s drug regulator, Health Canada, has approved the enoxaparin sodium biosimilars Apo-teriparatide, Teva-teriparatide and Osnuvo.
FDA approves rituximab biosimilar Riabni
US-based biotech giant Amgen announced on 17 December 2020 that it had received approval from the US Food and Drug Administration (FDA) for its rituximab biosimilar Riabni (ABP 798).
EMA recommends approval of adalimumab and insulin aspart biosimilars
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 December 2020 that it had recommended granting marketing authorization for the adalimumab biosimilar Yuflyma and for the insulin aspart biosimilar Kixelle.
Canada approves heparin biosimilars Redesca and Redesca HP
Canadian pharmaceuticals firm Valeo Pharma (Valeo) announced on 9 December 2020 that Canada’s drug regulator, Health Canada, had approved its low molecular weight heparin (LMWH) biosimilars Redesca and Redesca HP.
EC approval for pegfilgrastim biosimilar Nyvepria
The European Commission (EC) has granted marketing authorization for the pegfilgrastim biosimilar Nyvepria (PF-06881894), developed by US-based drugmaker Pfizer and its subsidiary Hospira.
China approves adalimumab copy biological HLX03
China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 7 December 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved its adalimumab copy biological HLX03.
