Amgen, Allergan biosimilar of Roche's blockbuster Rituxan clears another US pivotal study
Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.
Rituxan is one of Roche’s top-selling medicines, it generated about $6.9 billion in global sales last year.
In the United States, Celltrion and Teva’s $TEVA Rituxan biosimilar, Truxima, was approved last November by the FDA. The month prior, Novartis threw in the towel on getting its copycat US approval — after the health regulator demanded extra information, which skewed its timeline to the finish line and enabled its rivals to leapfrog it. This July, Pfizer’s $PFE Rituxan knockoff, Ruxience, secured its FDA approval.
In recent years, Roche has been feeling the heat — and batting away — biosimilar rivals eating into revenues for its big Rituxan, Herceptin and Avastin franchises.
In Europe, where Rituxan is branded as MabThera, sales declined by 47% in 2018 as Celltrion and Novartis’s knockoffs took a bite out of its market share.
But in the United States, the magnitude of discounts offered by biosimilar makers dwarf the cuts seen in Europe, leading some critics to conclude that the US biosimilar market is broken.
“Even today there are barely a dozen biosimilars on the U.S. market and no competitors on the horizon for dozens of biologic drugs. The barriers to entry are so high that even the hundreds of millions in sales these uncontested products generate isn’t enough to attract even one competitor,” influential researcher Peter Bach, Director of the Drug Pricing Lab at Memorial Sloan Kettering Cancer Center, wrote in an opinion piece published in the Wall Street Journal on Wednesday, along with co-author Mark Trusheim, who serves as strategic director of MIT’s New Drug Development Paradigms.
Bach and Trusheim also prescribed an antidote: government price regulation that gives a manufacturer a ‘fair price’ after the biologic’s period of exclusivity ends.
“Most issues in drug pricing are contentious. Ending monopoly pricing after a company has been rewarded for innovation isn’t. Pursuing biosimilars might seem like a solution, but this approach is drawing patients away from studies of newer therapies even as it fails to control costs. Price regulation may be a tough sell in some quarters, but it’s the best way to keep the promise of America’s extraordinary pharmaceutical industry alive,” they concluded.