Biosimilars/News
Revance and Mylan move forward with Botox biosimilar
US firm Revance Therapeutics (Revance) announced on 1 June 2020 that its partner, US-based drugmaker Mylan, had decided to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Allergan’s cosmetic blockbuster Botox and Botox Cosmetic (onabotulinumtoxinA).
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.
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).
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).
