U.S. FDA panel supports Novartis version of Amgen arthritis drug

Amgen’s version of AbbVie’s big-selling Humira has moved a step closer to United States approval with a unanimous vote in favour of the new drug by one of the FDA’s influential committees.

Novartis AG’s biosimilar version of the arthritis drug Enbrel, which the Swiss company is seeking to sell in the U.S. market, is comparable to the original made by Amgen Inc., U.S. regulators said.

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.

The panel voted 26-0 in favour of Amgen drug, dubbed ABP 501, on the back of studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, which met their primary goals in showing clinical equivalence to Humira (adalimumab). It pulled off nearly $14 billion in sales a year ago, of which $8.4 billion was generated from the United States population. The injectable drug, which blocks chemicals linked to inflammation, is approved for multiple uses, including rheumatoid arthritis, Crohn’s disease and psoriasis.

In the document, the FDA said: “The data submitted by Amgen support a demonstration that ABP 501 is highly similar to US-licensed Humira, notwithstanding minor differences in clinically inactive components, and support a demonstration that there are no clinically meaningful differences between ABP 501 and US-licensed Humira in terms of the safety, purity and potency of the product”. The drugs take an estimated $40-300 million to develop in five years, compared to generic drugs, which cost no more than $2-5 million and just about 2-3 years to develop. In 2015, six of the 10 top-selling medicines globally were biotech drugs, with more than $56 billion in combined sales. Pfizer won approval to market a second biosimilar in April, a version of Johnson & Johnson’s Remicade, but it is not yet for sale. Another Amgen top-seller, Enbrel, is facing risk from Novartis’ biosimilar version, which has already been accepted for a review by the FDA.