Can Humira still dominate in 2022?

The forecast best-selling drug in 2022 might come as a surprise to some: AbbVie’s veteran Humira is set to regain the top spot, according to extended EvaluatePharma consensus data (see tables below). However, this estimate probably does not fully take into account the impact of biosimilars, which could lead to a steeper decline in revenues than expected.

Meanwhile, Gilead’s hepatitis C drugs have come off the boil as the pool of treatable patients dwindles – but the potential of its new doublet and triplet combos is probably underestimated. The newer agents are currently forecast to bring in around $900m between them by 2022, but potential advantages, including a shorter treatment duration, should boost uptake.

Biosimilar uncertainty

AbbVie’s chief executive, Rick Gonzalez, has pledged to keep Humira biosimilars off the market until 2022, but several are already knocking on the door.

The closest to market is Amgen’s ABP 501, which is under review at the FDA. While this could be approved as early as September, market entry is likely to be delayed as AbbVie has vowed to bring the biosimilar battle to the patent courts.

The outcome of the so-called patent dance between Humira and ABP 501 will be an indication of whether AbbVie can hold off biosimilars. Coherus BioSciences will no doubt be watching closely – it also has a Humira copycat in the works.

Humira could also be hit by biosimilars of other anti-TNF MAbs like Pfizer’s Inflectra, a lookalike of Johnson & Johnson’s Remicade that was recently approved in the US (US biosimilar space reaches its Inflectra point, April 6, 2016). 

Another entry in the 2022 top-10 marketed drugs is also looking doubtful: Novartis’s Entresto, which had a slower-than-expected launch last year. New 2016 guidance from the company of $200m is well below current consensus, and it is looking increasingly unlikely that the drug’s sales will hit the 2022 estimate (Entresto’s $5bn challenge, April 21, 2016).

As for R&D assets, it is not so surprising to see Roche’s ocrelizumab and atezolizumab at the top of the charts, followed by Sanofi’s dupilumab – all three have for some time been the most eagerly anticipated drugs in development (Roche gets back to business – R&D upgrades and downgrades, February 10, 2016). 

But Intercept’s obeticholic acid, or Ocaliva, is on shakier ground: although a recent advisory committee voted in favour of approval for its first indication, primary biliary cirrhosis, the bigger – but more uncertain – opportunity is in nonalcoholic steatohepatitis (NASH). If the drug fails to live up to expectations here then the forecast could fall dramatically.

As market dynamics become clearer it is possible that Ocaliva, along with Humira and Entresto, will see downgrades. But there are plenty of drugs ready to take their places. Bristol-Myers Squibb’s Opdivo, seemingly on a never-ending quest to add new cancer indications to its label, seems a likely candidate for Humira’s crown.

To contact the writer of this story email Madeleine Armstrong in London at [email protected] or follow  @medtech_ma on Twitter