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RSS FeedPosted by Michael Wonder on 17 Jan 2023
Celltrion gets nod from Canadian regulator for sales of Avastin biosimilar
17 January 2023 - Celltrion obtained permission from Health Canada to sell Avastin (bevacizumab) biosimilar Vegzelma (CT-P16) on Tuesday. ...
Posted by Michael Wonder on 04 Jan 2023
Samsung Bioepis announces Health Canada approval of citrate free high concentration of Humira biosimilar (adalimumab; SB5)
3 January 2023 - With the approval, Samsung Bioepis has both low (40 mg/0.8 mL) and high (40 mg/0.4 mL) concentration ...
Posted by Michael Wonder on 29 Nov 2022
Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU
29 November 2022 - Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...
Posted by Michael Wonder on 14 Sep 2022
Lupin receives Health Canada approval for Rymti (biosimilar etanercept)
13 September 2022 - Rymti is Lupin’s biosimilar etanercept approved for all indications of the reference product. ...
Posted by Michael Wonder on 20 May 2022
Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada
19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada. ...
Posted by Michael Wonder on 10 Mar 2022
Health Canada approves Samsung Bioepis and Biogen’s Byooviz (SB11), Lucentis biosimilar (ranibizumab)
10 March 2022 - Byooviz becomes the first Lucentis biosimilar to be approved in Canada following its approval in Europe and ...
Posted by Michael Wonder on 04 Feb 2022
Samsung Bioepis announces Health Canada approval of 150 mg single-use vial and 440 mg multi-dose vial of Ontruzant (SB3), trastuzumab biosimilar for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer
2 February 2022 - 150 mg and 440 mg vial of Ontruzant are now approved in Canada. ...
Posted by Michael Wonder on 01 Feb 2022
Celltrion Healthcare announces Canadian approval of Yuflyma, a high concentration, low volume, citrate free and latex free Humira (adalimumab) biosimilar
31 January 2022 - Yuflyma brings a new offering to healthcare practitioners and their patients with inflammatory diseases in Canada. ...
Posted by Michael Wonder on 13 Jan 2022
JAMP and Alvotech announce Canadian approval of Simlandi, a high concentration biosimilar to Humira, providing access to previously unavailable versions in Canada
10 January 2021 - Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject ...
Posted by Michael Wonder on 31 Dec 2021
Celltrion acquires approval for its new Humira 'Yuflyma' in Canada
30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...
Posted by Michael Wonder on 18 Feb 2021
Viatris launches Hulio (adalimumab biosimilar) in Canada
18 February 2021 - Viatris announced today that Health Canada has approved Hulio, and product is now available in Canada. ...
Posted by Michael Wonder on 17 Feb 2021
Sandoz Canada completes its fifth biosimilar launch with new biosimilar Hyrimoz (adalimumab)
16 February 2021 - Hyrimoz for use in nine indications covered by the reference medicine in the fields of rheumatology, gastro-enterology ...
Posted by Michael Wonder on 02 Feb 2021
Celltrion Healthcare receives Health Canada marketing authorization for world's first subcutaneous formulation of infliximab, Remsima SC, for the treatment of people with rheumatoid arthritis
1 February 2021 - This novel formulation provides an alternative administration option for Canadian physicians and their patients. ...
Posted by Michael Wonder on 18 Dec 2020
Sandoz Canada receives authorisation from Health Canada to launch new biosimilar Hyrimoz (adalimumab)
17 December 2020 - Hyrimoz approved for use in all same indications as reference medicine* including rheumatology, gastro-enterology and dermatology. ...
Posted by Michael Wonder on 10 Dec 2020
Valeo Pharma announces Health Canada approval for Redesca and Redesca Hp
9 December 2020 - Valeo Pharma announced today that Health Canada has issued a Notice of Compliance for Redesca and ...