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Japanese approval for first adalimumab biosimilar

Japan-based Fujifilm Kyowa Kirin Biologics announced on 29 June 2020 that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its adalimumab biosimilar FKB327 in Japan.

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.

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).

Daewon launches teriparatide biosimilar in South Korea

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

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.

China approves 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 approved HLX14, a denosumab copy biological.

EMA recommends approval of trastuzumab biosimilar Zercepac

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 May 2020 that it had recommended granting of marketing authorization for a biosimilar trastuzumab product.

Teva launches rituximab biosimilar Truxima in US

Israeli generics giant Teva Pharmaceutical Industries (Teva) and partner, South Korean biotechnology company Celltrion, announced on 4 May 2020 that they had launched their rituximab biosimilar Truxima (TL011) in the US.