FiercePharma, by Arlene Weintraub,
AbbVie investors have been bracing for the mother of all patent cliffs—the loss of exclusivity on the company’s $18-billion-per-year Humira—and now its impact is starting to come into view. The mass exodus from the branded product to biosimilars confirms what AbbVie’s executives have already admitted, which is that their initial estimate of a 20% revenue loss in Europe by 2020 was way too optimistic.
That’s one main takeaway from a new Bernstein report on biosimilar adoption rates. Humira biosimilars just hit the market in Europe in October, but pickup has been so strong that Bernstein analyst Ronny Gal took one look at the first full month of sales data and confirmed that the hit on AbbVie’s revenues will come earlier than expected.
“The adoption is essentially all in Germany, with some early noise in France and Italy,” Gal said in a video he posted for investors. With more conversions from brand to biosimilar to come in regions like the United Kingdom, Latin America and Scandinavia, he said it’s reasonable to expect “50% adoption of Humira biosimilars by volume within the first year” of its launch.
AbbVie executives said during the company’s fourth-quarter earnings call today that they expected $2 billion in lost sales outside the U.S. from Humira biosimilar competition this year. AbbVie Chairman and CEO Richard Gonzalez had previously said that he was expecting a total revenue loss in all countries outside of the U.S. of 26% to 27% in 2019 alone, but today the company upped that estimate to 30%.
By Gal’s calculations, the 26%-plus ex-U.S. revenue loss means AbbVie is expecting Humira biosimilars to erode European sales by about 40%.
There are four Humira biosimilars on the market in Europe, with two more to come. So far, Gal said, the main winner is the Biogen-Samsung joint venture, Bioepis, with its low-cost version of the drug, Imraldi. It has taken the biggest share of the European market for Humira biosimilars so far, according to Gal, with Amgen’s Amgevita following close behind.
Gal also reported rapid adoption of other biosimilars in Europe, including breast cancer treatment Herceptin. Copies of that Roche blockbuster have been on the market there for 7 months, but the adoption rate has already hit 14%—making it a faster conversion to biosimilars than what was seen with Roche’s Rituxan, Gal wrote.
The loss of exclusivity on Rituxan, Herceptin and Roche’s other cancer blockbuster, Avastin, has put a cumulative $20 billion in annual sales at risk. During the third quarter of 2018 alone, European sales of Rituxan fell 49% to CHF 206 million ($207 million).
More Information / Source: https://www.fiercepharma.com/pharma/humira-biosimilars-catch-fire-europe-and-could-take-half-market-a-year-report