Non-US Humira sales drop but AbbVie firm biosimilars are having no impact

Remicade biosimilars have had no meaningful impact on AbbVie’s parallel TNF inhibitor Humira, management says, despite international Q2 sales of the mAb being down 14% year-on-year.

AbbVie reported total revenues of $5.5bn (€5bn) for the second quarter 2015, up 11% on the same period last year. The firm’s TNF inhibitor monoclonal antibody Humira (Adalimumab) contributed $3.5bn to this total, but while the drug experienced a 29% growth in sales in the US, international sales fell 14% year-on-year to $1.4bn.

While some of this was attributed to the impact of exchange rate fluctuations, management told investors during a conference call it was shipment timings, and not biosimilar competition, which added to the sales decline.

“The first quarter international growth rate of nearly 15% was favorably impacted by the timing of shipments in select markets,” said AbbVie CFO William Chase. “Consequently international sales growth in the second quarter was negatively impacted by the shipment timing.

"Market growth internationally remained strong with most major markets experiencing double-digit growth and Humira's international market share has remained stable despite new competitors and the launch of biosimilar infliximab.”

Biosimilar competition

Humira’s patent is not set to expire in the US until December 2016 and in Europe until April 2018. However, last December, the first – and only – Humira biosimilar was launched by Zydus Cadila in India at one fifth of the US price.

But Janssen’s Remicade (infliximab), like Humira, targets tumour necrosis factor alpha (TNF-α) to treat autoimmune diseases, and with biosimilar versions now approved in 46 countries, investors asked on the call whether this was eating away at AbbVie’s sales.

“We measured every one of those markets that they are in, we've been doing it from the very beginning and in those markets Humira continues to grow as we would have expected it. We don’t see any impact from nor did we expect any impact from Remicade biosimilars within those markets,” CEO Richard Gonzalez responded.

“If you look at markets that they have been in for more than a year to be able to measure what their market share is, their total market share is 2.8%, so they haven’t any meaningful impact,” he continued, adding the drop in sales “is nothing more than shipment timing.”