Tony Hagen is senior managing editor for The Center for Biosimilars®.
After 17 years on the US market, Humira (adalimumab) proves it can still generate high sales, but competition from biosimilars is growing.
As it inches closer to encountering biosimilar competition in the United States, AbbVie continues to see US sales of its adalimumab (Humira) originator product increase.
Over the past year, the company has battled with biosimilar competition to this arthritis product on the European market and has seen steepdeclines in revenue there. Whether the European situation for adalimumab is a representation of what is to come in the United States in 2023, when Humira loses market exclusivity, remains to be seen.
Meanwhile, 2 Humira follow-on products appear to be gaining ground. AbbVie anticipates these will absorb a share of the adalimumab market, in the face of biosimilar competition.
Further, biosimilar competition for AbbVie may take on an added dimension if Mylan and Revance team up to develop an onabotulinumtoxinA (Botox) biosimilar. AbbVie will acquire the original Botox product when it closes on the pending Allergan acquisition.
US Sales up 13.7%
In the United states, Humira net revenues were $3.7 billion for AbbVie in the first quarter of 2020, up 13.7% from the year-ago quarter. Outside the United States, however, Humira net revenues were $1 billion, down 14.9%, also from the year-ago quarter and a drop that the company blamed on biosimilar competition.
At least 9 biosimilar adalimumab products are lined up to enter the US market in 2023, so these are important final years of dominance for Humira, which entered the US market in 2003.
Full 2019 US revenues for Humira were $14.9 billion, up 8.6% from 2018. But 2019 also saw heavy biosimilar competition in Europe eroding market share for Humira, which outside the United States earned $4.3 billion, down 31.1% compared with 2018.
In Europe, adalimumab lost patent protection in 2018, and at least 6 adalimumab biosimilars have been approved for marketing there. The road to market entry for these products has not been without pitfalls.
In the Netherlands, AbbVie was so desperate to fend off competition that it slashed prices of Humira by up to 89%, according to the Groene Amsterdammer. This reportedly caused biosimilar competitors of the product to reconsider entering the market at all.
However, 2019 year-end results for Humira show that biosimilar competitors in Europe have attained a very sizeable share of the market that continues to increase.
As the halcyon days for Humira’s US dominance near an end, AbbVie continues to see impressive results for 2 follow-on products that it hopes will cushion the blow from biosimilar competition against its blockbuster product.
Skyrizi (risankizumab), which treats psoriasis,was launched in May of 2019 and quickly began racking up the sales. The product netted global revenues of $355 million for theyear. Rheumatoid arthritis pill Rinvoq (upadacitinib) launched in August 2019 and had net revenues of $47 million through December 2019.
AbbVie predictstotal 2020 sales of $1.7 billion for those 2 drugs, and based on first-quarter 2020 results, that may not be an unrealistic assumption. Skyrizi netted sales of $300 million in the just-ended quarter, and Rinvoq took in $86 million. “Skyrizi global revenues of $300 million were…significantly above expectations,” said Richard A. Gonzalez, chairman of the board and chief executive officer of AbbVie. “Rinvoq is also performing at a very high level in the [rheumatoid arthritis] segment.”
A Wrinkle in the Negotiations
Mylan revealed in late 2018 that it was negotiating with Revance to jointly bring a Botox biosimilar to market. There are no patent restrictions on the originator product, although its formulation is a trade secret.
Mylan has not been able to reach a final decision on whether to move forward with the partnership, and in a statement released on May 1, 2020, Revance said that although an April 30, 2020, decision deadline had come and gone, the two had decided to continue discussing the potential for a deal. “Revance will issue an update on the path forward for the program once Mylan’s decision has been reached,” the company said in a statement.
Revance has a Botox-like product of its own, Daxi (daxibotulinumtoxinA), but plans to bring this to market may be contingent on the outcome of the Mylan negotiations. The company announced in February that the FDA had accepted its application for approval of the product.