Amneal has laid out its plans to enter the US biosimilars market after receiving FDA approval for its first biosimilar, a Neupogen rival known as Releuko (filgrastim-ayow) that was developed with partner Kashiv Biosciences. Amneal also intends to launch two more biosimilars soon, along with 20-30 generics launches planned in 2022.
Amneal Pharmaceuticals, Inc. has announced receiving US Food and Drug Administration approval for its first biosimilar, a Neupogen rival that will be marketed under the name Releuko (filgrastim-ayow). Co-CEOs Chirag and Chintu Patel commented, “The US approval of our first biosimilar is a very significant milestone for Amneal.”
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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.
