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.
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By Bioblast Editor | Feb 17, 2021
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.
By Bioblast Editor | Feb 17, 2021
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 ...
By Naomi Pearce | Feb 16, 2021
Date: 16 February 2021Forum: Australian Patent OfficeDelegate: Kevin Restrick
Background
Under Australian law, business methods are not patent eligible because they are ...
By Naomi Pearce | Feb 15, 2021
As discussed in Part 1 of this blog series, TGA has invited submissions by 23 March 2021 on its consultation paper released last Thursday designed to facilitate indication “repurpos...
By Pearce IP | Feb 15, 2021
In honour of UN International Day of Women and Girls in Science
Last Thursday was the International Day of Women and Girls in Science, marking 6 years since the United Nations...
By Naomi Pearce | Feb 15, 2021
04 Feb 2021 | Roche reported a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth ...
By Bioblast Editor | Feb 15, 2021
Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® 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 Di...
By Bioblast Editor | Feb 15, 2021
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.
By Bioblast Editor | Feb 13, 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 right...
By Bioblast Editor | Feb 12, 2021
Biocon Biologics and Viatris announced Kixelle® (biosimilar insulin aspart) has received marking authorisation approval in the EU.
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