While Celltrion has delivered an unimpressive first quarter of 2021, the company has pointed to plans to launch high-margin products in new markets. The Korean firm said that it was looking to launch its subcutaneous Remsima SC infliximab formulation in Canada and Australia in 2021, while it is also aiming to launch its Yuflyma (adalimumab) in more than 70% of the EU adalimumab market.
Celltrion, Inc. has announced that it will launch its subcutaneous Remsima SC infliximab formulation in further global markets such as Canada and Australia this year, after completing the launch of Remsima SC in more than 70% of the EU market by the end of the first quarter of 2021, including EU5 countries such as France, Spain and Italy.
Citing an IQVIA report published in 2020, Celltrion said that with Remsima SC it will be targeting a $1.8bn TNF-α...
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.
