adalimumab Archives | Page 6 of 48

TGA approves Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02

by Bioblast Editor | Sep 6, 2022 | Biosimilars updates

Australia’s TGA approved Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02 (Ciptunec®/Ardalicip®) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic...

Alvotech receives complete response letter from FDA for AVT02

by Bioblast Editor | Sep 5, 2022 | Biosimilars updates

Alvotech announced that it has received a complete response letter from the FDA in relation to its BLA for AVT02 (biosimilar adalimumab). Alvotech anticipates being launch ready by the expected US launch date of 1 July 2023 .

Alvotech publishes financial results

by Bioblast Editor | Aug 31, 2022 | Biosimilars updates

Alvotech published its first half 2022 financial results, reporting a revenue growth to over $40 million compared to $2.0 million in the first half of 2021 due to recent launches of adalimumab (AV02) in Canada and Europe. The company has $128.4Min cash/equivalents...

STADA publishes half year financial results

by Bioblast Editor | Aug 25, 2022 | Biosimilars updates

STADA published its first half 2022 financial results, reporting a 15% increase in adjusted group sales. Adjusted for currency fluctuations and special effects, earnings before interest, tax, depreciation and amortisation (EBITDA) improved by 23% to €386.5 million. ...

Samsung and Organon announce FDA approval of high concentration adalimumab biosimilar (HADLIMA)

by Bioblast Editor | Aug 17, 2022 | Biosimilars updates

Samsung Bioepis and Organon announced that the FDA has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima™ (biosimilar adalimumab). The Hadlima 50mg/ml formulation was FDA approved in July 2019. Hadlima is expected to be launched on or...