FDA approves latest Humira near-copy, as dozens of biosimilars head for market


The FDA has approved Pfizer’s biosimilar of AbbVie’s blockbuster Humira (adalimumab), meaning that there are now five of these cheaper near-copies teed up to compete when the originator’s patent expires in 2023.

Pfizer will market the competitor under the brand name Abrilada (adalimumab-afzb), which is the 25th biosimilar approved by the FDA, but will have to wait until November 2023 to launch it following an agreement with AbbVie.

AbbVie has managed to fend off challenges to Humira's US patents until 2023, even though its European patent expired a year ago.

Humira's sales peaked at almost $20 billion last year, but the impact of biosimilars and more recently approved competitors are beginning to drag on revenues.

The FDA was slower to get an approval pathway for biosimilars up and running than its counterpart the European Medicines Agency.

Biosimilars are near-copies of complex biologic drugs that are grown in cells, and while there may be subtle differences compared with the original drug they have been shown to be as safe and effective in a series of rigorous trials and tests.

The first biosimilar was approved in Europe in 2006 after a dedicated approval pathway was established in 2003.

Since the first approval of a version of the growth hormone somatropin, and the EMA has approved 62 biosimilars to date.

In the US, the biosimilar approval pathway was not in place until 2009, and it took until 2015 before the FDA finally okayed the first drug using the pathway, which is intended to be cheaper to use than for novel drugs.

However since then the FDA has been championing biosimilars, and according to Sarah Yim, acting director of the Office of Therapeutic Biologics and Biosimilars at the FDA, there are now 74 potential drugs for 38 different reference products enrolled on the regulator’s Biosimilar Product Development Program.

The FDA has also put a Biosimilars Action Plan in place to improve efficiency of development and approval.

In March next year, there will also be further changes to laws that will lead to the development of biosimilar insulins.

While this is possible under the European system, companies launching insulin copycats in the US have had to apply for licences using pathways set aside for novel drugs, a more costly process.

Yim said this could lead to biosimilar insulins that are more affordable and are interchangeable with the originator product.

While the number of biosimilars approved looks set to increase in the US, originator companies such as AbbVie have had considerable success in protecting their products using the country’s patent laws.

Novartis has not had this issue with its biosimilar of Amgen’s long-lasting white blood cell booster, Neulasta (pegfilgrastim).

Despite Amgen’s litigious reputation Novartis’ Sandoz division said it launched its competitor Ziextenzo last week.