Coherus BioSciences has heralded a “strategic inflection point” for the company after receiving USFDA approval for Cimerli as an interchangeable biosimilar rival to Lucentis. The firm has also revealed launch plans for the Bioeq-partnered ranibizumab product.
Coherus BioSciences says the US Food and Drug Administration’s approval of its Bioeq-partnered Cimerli (ranibizumab-eqrn) as the first and only interchangeable biosimilar rival to Roche’s Lucentis represents a “strategic inflection point” for the company as it gears up to launch four new products by the end of 2023.
A launch for Cimerli is planned for early October 2022, with the product benefiting from 12 months of first interchangeable...
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.
