Biosimilars/News
Samsung Bioepis and AffaMed to start trastuzumab trial in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has granted approval for partners Samsung Bioepis and AffaMed Therapeutics (AffaMed) to start a phase III trial for their trastuzumab product, SB3.
FDA approval for Amgen’s infliximab biosimilar Avsola
US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its infliximab biosimilar Avsola (ABP 710).
Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the Investigational New Drug (IND) application from Bio-Thera Solutions (Bio-Thera) to initiate a phase I clinical study for the proposed ustekinumab copy biological BAT2206.
Australia approves five biosimilars since June 2019
Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosimilars, a trastuzumab biosimilar and a bevacizumab biosimilar.
Phase III trials started for bevacizumab and natalizumab biosimilars
Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.
EC approval for subcutaneous infliximab biosimilar Remsima SC
South Korean biotechnology company Celltrion Healthcare (Celltrion) announced on 26 November 2019 that it had received European Commission (EC) approval for the subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).
Lupin to launch etanercept and pegfilgrastim biosimilars in the US
India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar.
FDA approves adalimumab biosimilar Abrilada
US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).
Qilu starts phase III trial for denosumab copy biological
Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).
Adalimumab 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 the approval of adalimumab copy biological UBP1211.
