2017 U.S. sales: $4.41 billion
Disease: Blood cancers, rheumatoid arthritis
Competition expected: Mid- to end-2018
Analysts have long been forecasting trouble for Roche's top-selling biologics, and after some early damage from biosimilars in Europe, more competition is expected later this year when Roche reports megablockbuster Rituxan could face U.S. competition from copies.
First approved in 1997 in the U.S., Rituxan treats certain patients with follicular lymphoma, diffuse large B-cell lymphoma and chronic lymphocytic leukemia. The med generated $4.41 billion (CHF4.133 billion) in the U.S. last year, making it this year’s top patent expiration. A host of companies including Pfizer, Mylan and Amgen have biosimilars in the works.
Sandoz and Teva have already reported submitting their respective biosims to the FDA for review.
As industry watchers know, the biosim market has taken off slower in the key U.S. market compared to Europe, where competition shaved 11% off of sales in 2017. A copy from Celltrion has reportedly captured 80% of the market in Britain since its 2017 launch there. But thanks to complex patent shields and litigation, predicting U.S. biosimilar entry is no easy task. Roche said in its annual filing that there are “still many uncertainties” surrounding biosimilar competition to its key med, but that it could face off against competition in the middle or end of 2018.
For their part, Jefferies analysts wrote in September that they are modeling a third-quarter 2018 biosim launch. Analysts at Credit Suisse and Mizuho also expect competition to materialize this year.
Rituxan isn’t the only Roche med facing the prospect of near-term competition. Other blockbusters Herceptin and Avastin aren’t too far behind, according to Jefferies. The analysts wrote that Herceptin could face biosim rivals next year, and Avastin in 2020.
Together with Rituxan, the drugs pulled in more than $21 billion in 2017, and the threat is forcing Roche to look to new meds to fuel growth. Among them are Ocrevus and Hemlibra, approved in 2017 to treat multiple sclerosis and hemophilia, respectively.
Besides potential competition to Rituxan, Roche also faces the loss of Cabilly patents this year. The team at Jefferies predicts the loss of those manufacturing patents will lead to about a $533 million decline in royalty income next year.
Even if Rituxan biosims make it to market this year in the U.S., it remains to be seen how much success they’ll have. As industry watchers know, with the use of discounts and exclusive agreements, Johnson & Johnson has been able to protect its big branded biologic Remicade in the face of competition from Merck and Pfizer. The strategy led to a lawsuit from Pfizer alleging anticompetitive tactics.