The first biosimilar approval stemming from Alvotech’s collaboration with JAMP Pharma in Canada has arrived, with the firms’ Simlandi (adalimumab) biosimilar version of AbbVie’s higher-strength Humira. Celltrion has also announced an approval from Health Canada.
Celltrion has claimed a landmark first approval in Canada for a biosimilar product referencing AbbVie’s higher-strength 100mg/ml version of Humira (adalimumab), days before Alvotech and partner JAMP Pharma also received a marketing authorization from Health Canada for their higher-strength biosimilar Humira product.
The Korean firm’s Yuflyma biosimilar adalimumab product “is the first adalimumab biosimilar with a high concentration, low-volume and citrate-free formulation”...
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.
Amneal has marked its entry into China after receiving its first product approval in the market. Meanwhile, the firm has also outlined US approvals for two generics currently suffering from shortages.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
The UK government has said it will invest almost £30m ($40.4m) in AI technologies to modernize the NHS and reduce wait times – but for the medtech sector, the devil will be in the details.
