Biosimilars/News
Rituximab biosimilar ABP 798 submitted to FDA
US-based biotech giant Amgen and its partner Allergan announced on 19 December 2019 that their rituximab biosimilar (ABP 798) had been successfully submitted to the US Food and Drug Administration (FDA) for review.
Teriparatide biosimilar Terossa approved in South Korea
South Korea-based Daewon Pharmaceutical has obtained regulatory approval to begin marketing and selling its teriparatide biosimilar in Korea.
Phase I trials started for aflibercept and ustekinumab biosimilars
Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.
South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.
Bevacizumab and teriparatide biosimilars launched in Japan
Biosimilars for osteoporosis treatment teriparatide and for anticancer drug bevacizumab were launched in Japan in late 2019.
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).
