Biosimilars/News
FDA approves Mylan’s adalimumab biosimilar Hulio
The US Food and Drug Administration (FDA) has approved Mylan/Fujifilm’s adalimumab biosimilar Hulio (adalimumab-fkjp) on 7 July 2020. The product is the sixth adalimumab biosimilar to be approved by FDA and is manufactured by Japan-based Fujifilm Kyowa Kirin Biologics.
Celltrion launches Truxima in Brazil
On 27 May 2020, South Korean biotechnology company Celltrion Healthcare (Celltrion) announced that it had launched its rituximab similar biotherapeutic product Truxima (CT‑P10) in Brazil.
Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym
Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.
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.
