FDA Staff Says Novartis AG Copy of Amgen's Blockbuster Enbrel is 'Highly Similar'
Novartis AG's cheaper version of Amgen Inc's blockbuster rheumatoid arthritis drug Enbrel is "highly similar" to the original, according to a preliminary review by Food and Drug Administration staff.
The review, posted on the FDA's website on Monday, comes two days ahead of a meeting of outside advisors who will discuss the drug and recommend whether it should be approved.
The FDA is not obliged to follow the advice of its advisory panels but typically does so.
The review, posted on the FDA's website on Monday, comes two days ahead of a meeting of outside advisors who will discuss the drug and recommend whether it should be approved.
The FDA is not obliged to follow the advice of its advisory panels but typically does so.