After receiving approval from the Chinese regulatory body for rituximab and trastuzumab, Shanghai Henlius Biotech has now received approval for its HLX03 adalimumab biosimilar rival to Humira. The company has partnered with Wanbang Biopharma for commercialization of HLX03 in China.
Shanghai Henlius Biotech has announced that its HLX03 adalimumab biosimilar rival to Humira has been approved by China’s National Medical Products Administration. Henlius noted that its adalimumab biosimilar was the third monoclonal antibody that has been developed and manufactured by the company and approved in China.
Wenjie Zhang, CEO and president of Henlius, said “the approval of this product marks the expansion of the company's commercial...
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.
