Lupin and YL Biologics have obtained approval from Japanese regulator PMDA to manufacture and sell biosimilar etanercept in the region. The firm has also just received GMP certification in the EU for its Indian Pune facility where the drug will be produced.
Lupin has revealed that its YL Biologics joint venture with Yoshindo, as well as Lupin’s Japanese subsidiary Kyowa, have received approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to manufacture and sell their YLB113 biosimilar etanercept in Japan.
In February 2018, YL Biologics’ global Phase III study comparing YLB113’s efficacy and safety against Pfizer’s Enbrel (etanercept) met its...
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.
