Nora Pharma receives Health Canada approval for Niopeg, a biosimilar of Neulasta

19 April 2024 - Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the ...

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Alvotech and Teva announce US FDA Approval of Selarsdi (ustekinumab-aekn), biosimilar to Stelara (ustekinumab)

16 April 2024 - Selarsdi is expected to be marketed in the US on or after 21 February 2025, following a ...

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Formycon announces commercial launch of FYB201 (ranibizumab) in Canada (Ranopto) and Switzerland (Ranivisio)

11 April 2024 - Commercialization partner Teva markets FYB201 in Canada under the trademark Ranopto and in Switzerland under the trademark ...

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Zymfentra (infliximab-dyyb), the first and only FDA approved subcutaneous infliximab, now commercially available in the U.S.

17 March 2024 - Zymfentra is commercially available across the US on 15 March 2024. ...

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Celltrion USA completes submission of biologics license application to US FDA for CT-P39, an interchangeable biosimilar candidate of Xolair (omalizumab)

10 March 2024 - The BLA for CT-P39 was based on totality of evidence including results from Phase III data ...

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Fresenius Kabi’s biosimilar Tyenne (tocilizumab-aazg) becomes the first intravenous and subcutaneous tocilizumab biosimilar approved by the FDA

7 March 2024 - Fresenius Kabi announced today that the US FDA has approved Tyenne (tocilizumab-aazg), its tocilizumab biosimilar referencing Actemra ...

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Wezlana (ustekinumab), a biosimilar to Stelara, now available in Canada for certain chronic inflammatory diseasee

4 March 2024 - Wezlana is the first biosimilar to Stelera to be available for Canadian patients in all indications. ...

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Sandoz receives FDA approval for first and only denosumab biosimilars

5 March 2024 - Wyost (denosumab-bddz) and Jubbonti (denosumab-bddz) interchangeable with and approved by FDA for all indications of reference ...

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Alvotech and Teva announce US approval of Simlandi (adalimumab-ryvk) injection, the first interchangeable high concentration, citrate free biosimilar to Humira

23 February 2024 - Simlandi is the first citrate free, high concentration biosimilar to be designated interchangeable to Humira in the ...

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Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis

20 February 2024 - Biosimilar Jubbonti approved for all indications of Prolia reference medicine. ...

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Health Canada approves Remsima SC for the treatment of inflammatory bowel disease

18 February 2024 - The approval is based on results from the LIBERTY studies demonstrating superior efficacy and comparable safety profiles ...

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Celltrion seeks European approval for Actemra biosimilar

13 February 2024 - Celltrion said it has completed its application for marketing authorisation to the EMA for CT-P47, a ...

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Medicare patient access to Humira biosimilars still falls woefully short

5 February 2024 - According to a Federal Government Medicare Payment Advisory Commission report published last month, more than 40% of ...

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Celltrion USA completes submission of biologics license application for CT-P47, a biosimilar candidate of Actemra (tocilizumab)

28 January 2024 - The biologics license application for CT-P47 was based on Phase III data comparing CT-P47 to the ...

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STADA and Alvotech secure approval for Uzpruvo, Europe’s first ustekinumab biosimilar to Stelara

10 January 2024 - Approval for the Uzpruvo biosimilar is based on comprehensive package comprising analytical, non-clinical and clinical similarity ...

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