Novartis AG’s cheaper version of Amgen Inc’s blockbuster arthritis drug Enbrel is highly similar in potency and safety to the original, according to a review by Food and Drug Administration staff.
The review, posted on the FDA’s website, comes two days ahead of a meeting of outside advisers who will discuss the drug and recommend whether it should be approved.
The FDA is not obliged to follow the recommendations of its advisory panels but typically does so.
Enbrel is an injected biologic drug made from living cells. Biologics are more complex than traditional pills and cannot be copied with precision. Copies are therefore called biosimilars, not generics.
Enbrel was approved in 1998 and generated more than $5 billion in U.S. sales last year. It works by blocking a protein known as tumor necrosis factor, or TNF, and is approved for a number of conditions, including rheumatoid arthritis, psoriasis and psoriatic arthritis.
Novartis, through its generic drug division Sandoz, is seeking U.S. approval for the same indications. The FDA review found there were no clinically meaningful differences between the two drugs in the studied condition of psoriasis.
The review found that the company had also provided an extensive data package to address scientific considerations to support biosimilarity to other conditions for which Enbrel is approved.
Dr. Joan Von Feldt, president of the American College of Rheumatology, cautioned in a statement against approving biosimilars for conditions for which they have not been studied and urged the FDA to provide clinical data from biosimilars on the drug’s label.
It could be some time before the drug reaches the market even if approved. Amgen has filed suit against Sandoz, claiming the company is “piggybacking on the fruits” of their research efforts.
Ironically, the same panel on Tuesday will discuss whether the FDA should approve Amgen’s biosimilar version of AbbVie’s TNF-inhibitor Humira, which generated U.S. sales last year of more than $8 billion.
In FDA documents posted on Friday, staff reviewers found Amgen’s version to be highly similar to Humira in treating rheumatoid arthritis, plaque psoriasis and other conditions.
In this instance, Amgen is in a legal battle with Abbvie, which claims its patents protect Humira against U.S. competition until at least 2022.
Novartis is the first to seek U.S. approval for a biosimilar to Enbrel. In January, Biogen Inc and Samsung Bioepis received European approval for their Enbrel biosimilar.