As it begins to roll out its Yuflyma higher-strength adalimumab biosimilar in Europe, Celltrion has reported positive one-year data from a Phase III trial for the 100mg/ml Humira rival.
Celltrion has revealed fresh one-year Phase III trial data for its Yuflyma (adalimumab) biosimilar rival to Humira as it begins the process of rolling out the product – the world’s first approved higher-strength adalimumab biosimilar – in various markets in Europe.
As it announced its recent first-quarter results, Celltrion indicated that it planned to have launched Yuflyma in more than 70%...
Sandoz snatched commercialization rights to Lupin’s ranibizumab biosimilar across multiple global markets, while also taking steps to decarbonize its operations in Europe.
Alongside biosimilars, Lupin sees injectable products as one of the key growth drivers in the US, as competition for two of its “material” drugs and proposed tariffs are looming over the firm.
Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.
Kashiv BioSciences has struck a deal with MS Pharma to market its omalizumab biosimilar rival to Xolair in the MENA region.
Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.
The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.
Amgen sees potential regulatory shifts toward streamlined biosimilar approvals as favorable, citing its strength in developing high-quality products.
