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EC approval for etanercept biosimilar Nepexto

The European Commission (EC) has granted marketing authorization for the etanercept biosimilar Nepexto (YLB113), developed by US-based drugmaker Mylan and its partner India-based generics maker Lupin.

China approves bevacizumab copy biological Byvasda

China-based drugmaker Innovent Biologics (Innovent) announced on 19 June 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved Byvasda (IBI-305), a bevacizumab copy biological.

Canada approves pegfilgrastim biosimilar Ziextenzo

Canada’s drug regulator, Health Canada, has approved the pegfilgrastim biosimilar Ziextenzo (LA-EP2006). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Daewon launches teriparatide biosimilar in South Korea

South Korea-based Daewon Pharmaceutical (Daewon) announced that it has launched the teriparatide biosimilar Terrosa.

China accepts IND application for denosumab copy biological HLX14

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 27 May 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had accepted an investigational new drug application (IND) for HLX4, a denosumab copy biological.

Bio-Thera launches first adalimumab copy biological in China

Bio-Thera Solutions (Bio-Thera) announced in January 2020 the launch of the first adalimumab copy biological in China. The drug can be used to treat rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis and will be marketed as Qletli.

Mabpharm files infliximab copy biological application in China

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 6 January 2020 that its partner, China-based Mabpharm, had filed a marketing application with China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) for its infliximab copy biological (CMAB008).

China approves bevacizumab copy biological Ankada

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 9 December 2019 that it had approved Ankada, a bevacizumab copy biological.

FDA approves insulin glargine biosimilar Semglee

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its insulin glargine biosimilar Semglee (MYL‑1501D).

Fresenius Kabi’s pegfilgrastim biosimilar accepted for review by EMA and FDA

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 22 and 27 May 2020 that the regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) had been accepted by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively.