Pearce IP BioBlast™: w/e 19 February 2021

by , | Feb 22, 2021

13 Feb 2021 | Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.

15 Feb 2021 | EU | Celltrion announced it received EC marketing authorisation for Yuflyma® (biosimilar adalimumab) across all indications. This is the first approval of a high concentration, low-volume biosimilar adalimumab. The EPAR is yet to be published by EMA.

15 Feb 2021 | JP | Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® (biosimilar adalimumab) in Japan. Hulio® is available in a 40mg/0.8mL syringe and pen presentation (indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Entero-Behcet’s Disease and Crohn’s Disease), and a 20mg/0.4mL syringe (indicated for juvenile idiopathic arthritis). This is the first adalimumab biosimilar to be launched in Japan.

17 Feb 2021 | US | Coherus Biosciences announced the FDA has accepted the BLA for its biosimilar adalimumab candidate (CHS-1420). Coherus also announced that it plans to launch its product in the US on or after 01 July 2023. Coherus had previously disclosed that its license with AbbVie would commence in the US in December 2023.

17 Feb 2021 | CA | Sandoz announced that it has launched Hyrimoz®, its 50mg/mL biosimilar adalimumab in Canada. Hyrimoz® was approved by Health Canada in November 2020 with a full label. It was also previously launched in Europe in 2018.

18 Feb 2021 | CA | Fresenius Kabi announced it has launched Idacio® (biosimilar adalimumab) in Canada. Idacio® is available in 50mg/ml formulation (40mg/0.8mL syringe, vial and pen presentations) and is approved for all Humira® indications.

18 Feb 2021 | CA | Viatris announced it has launched Hulio® (biosimilar adalimumab) in Canada. Hulio® is available in a 50mg/ml formulation (40mg/0.8mL) and is approved for all adalimumab indications.

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