Daiichi Sankyo has introduced Amgen’s bevacizumab biosimilar in Japan, hot on the heels of Pfizer’s launch of its own rival to Avastin in the country.
Daiichi Sankyo has launched biosimilar bevacizumab 100mg and 400mg in Japan, under a partnership with Amgen. The launch marks the second biosimilar rival to Avastin to hit the Japanese market, after Pfizer earlier in December launched its own biosimilar bevacizumab in the country.
Having obtained a marketing authorisation approval from the Japan’s Ministry of Health, Labour and Welfare (MHLW) on 20 September this...
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.
