AbbVie Inc. will look to maintain its market share and maximize profitability as biosimilars threaten to cut into international sales of its top drug.
Two biosimilars for Humira were given a positive recommendation by the European Medicines Agency on the same day that AbbVie released its 2016 earnings and forecast for 2017. Humira, used to treat arthritis and a number of rheumatoid and dermatological ailments, accounted for $16.08 billion in global sales during 2016.
On a Jan. 27 earnings call, AbbVie CEO Richard Gonzalez said he believes the company's patents will protect Humira's U.S. market share through 2022. He noted that based on the recent FDA ruling on biosimilars, the two biosimilars, Amgen Inc.'s Amgevita and Solymbic, could have a more complicated process to get U.S. approval.
The company does not believe any of the current single-switch studies would meet the FDA standard. "But we will have to see how the competitive dynamics play out as people look at this and start to design programs in order to try to achieve interchangeability and so I think we will need to see how that plays out over time," said Gonzalez.
"The strategy that we have in place is not one that hinges on one or two patents," Gonzalez added, noting that the company has at least 110 patents.
In a research note, Barclays analyst Geoff Meacham said AbbVie shares could be under modest pressure given the EMA announcement, as well as mixed results from some of its non-Humira drug sales. Overall, Barclays said, "Humira headlines from biosimilar threats could continue to be a drag on sentiment despite what has been good pipeline progress overall."
The potential biosimilars competition comes after Gonzalez committed that the company would keep price increases below 10%. In the earnings call, Gonzalez reiterated that the company will do only one price increase per year and that all increases will be in single digits.
Gonzalez noted that most AbbVie assets have already received that single price bump for this year. Overall, he said, it is important for pharmaceutical companies to continue demonstrating their medicine's values as pricing pressures increase in the new U.S. administration.