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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.

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).

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).