Novartis AG (NYSE:NVS) could be dealt a major blow on its cheaper version of Amgen, Inc. (NASDAQ:AMGN) arthritis drug, Enbrel. The Food and Drug Administration (FDA) has raised concerns that the biosimilar drug is too similar to the original drug.
Approved in 1998, Enbrel is designed to block a protein known as tumor necrosis factor. The drug is approved for the treatment of rheumatoid arthritis, psoriasis, and psoriatic arthritis all of which the Novartis biosimilar claims to treat. The review team has already ruled that there is no difference between the two drugs.
Even though the FDA’s final decision is not tied to the advisory panel findings, the concerns raised so far could make it difficult for the agency to approve the new drug. The officials are to meet on Wednesday to decide the final fate of the new drug. Novartis is the first company to seek approval for a biosimilar to Amgen’s blockbuster arthritis drug.
The approval of the Novartis drug is the last thing that Amgen wants at the moment given that Enbrel was its best seller last year. The drug generated $5.36 billion in revenue. Since the approval of biosimilars in 2010 by Congress, the FDA has so far cleared only two drugs as biosimilars.
Legal Tussle over Biosimilars
Concerned by a possible approval, Amgen has already filed a lawsuit that seeks to block the usage of the proposed Novartis biosimilar. In its defense, the drug maker argues that the Novartis generic drug division is encroaching on the fruits of its research efforts.
Amgen could be accused of double standards on its lawsuit, given that it is also seeking the approval of a biosimilar version of Humira. AbbVie Inc (NYSE:ABBV) could raise similar concerns given that the FDA staff has already raised concerns that Amgen’s biosimilar is too highly similar to Humira. The blockbuster generated $8 billion in revenue last year.
AbbVie has already stated that its patents protect Humira from any kind of competition until 2022, something that regulators will have to consider.