Time to shine, biosims: Amgen's Amjevita readies long-awaited assault on AbbVie's Humira

No more waiting: Humira’s judgment day has finally arrived. The first Humira biosimilar, Amgen’s Amjevita, is set to reach the market Tuesday and kick off a tsunami-sized wave of competition.

With eight biosimilar launches coming up this year, including Amgen’s, the world's top-selling medicine is due for a serious showdown. For now, though, AbbVie's immunology blockbuster can reliably scoop up big sales as the other biosim players wait on the sidelines.

Thanks to a 2017 settlement with AbbVie, Amgen's Amjevita will enjoy several months as the lone Humira biosim in the U.S. More competition will start to reach the market in July.

Once all the biosims are available, the Humira market should resemble a competitive pharma field where each player tries to highlight their own strengths, Ian Thompson, Amgen's senior vice president and general manager of business operations in the U.S., predicted in a June interview.

Still, the sheer number of biosimilar launches for one drug will be unprecedented in this situation, Juliana Reed, executive director of the Biosimilar Forum, said in a recent interview with Fierce Pharma. And sailing uncharted waters can get choppy.

The forum, a D.C.-based nonprofit focused on expanding access to biosimilars, is concerned about formulary access for the new products. According to Reed, “a couple” pharmacy benefit managers have announced that they will have some Humira biosimilars on their formularies, but “no one” has said they will offer all of the options.

This leaves the organization “very concerned” that only two or three Humira biosimilars will get access to the market, leaving the rest shut out. That would hinder competition, meaning overall savings could fall short of the forum's hopes. 

It seems there are similar concerns across the board. In anticipation of the flood of Humira biosimilars, Cardinal Health recently surveyed healthcare providers in different therapeutic areas within Humira’s approved uses.

In a preview of its 2023 biosimilars report, which will be released in February, the top concerns cited by practitioners include safety and efficacy, interchangeability, pharmacy-level substitution and transitioning a patient from Humira to a biosimilar. Other worries are a lack of direct savings for patients and uncertainty around payer coverage decisions.

However, at least 75% of providers said they would be comfortable prescribing the biosimilars.

As for Humira marketer AbbVie, CEO Richard Gonzalez maintains that the company, which spent years fending off the competition, is well prepared. The company rushed to secure broad 2023 formulary access for Humira, signing agreements with “all of the major” players, Gonzalez said at this year’s J.P. Morgan Healthcare Conference. He’s confident that the company will return to growth in 2025 after two years of declining sales, with breakout immunology stars Skyrizi and Rinvoq helping pick up the slack.

AbbVie's Humira generated $20.7 billion last year, and market watchers have long wondered how the company will fare after its loss of exclusivity. Back in 2019, the company struck a $63 billion buyout of Allergan in part to reduce its reliance on Humira. Plus, AbbVie has said it expects Skyrizi and Rinvoq to eventually surpass Humira's peak sales level. 

After Amgen's Tuesday biosim launch, still to come later this year are Humira biosimilars from Boehringer Ingelheim, Novartis' Sandoz, Organon, Pfizer, Mylan, Coherus and Fresenius Kabi.