Research Alert


Researchers have developed the first report card on biosimilars for three blockbuster cancer drugs marketed by Genentech/Roche: Rituxan, Avastin and Herceptin. In a Policy Review in The Lancet Oncology, Y. Tony Yang, a professor at the George Washington University School of Nursing and Milken Institute School of Public Health, along with researchers at the University of South Carolina, the City of Hope Comprehensive Cancer Center in Duarte, California, the Virginia Mason Cancer Institute and Saint Louis University School of Medicine, identify factors preventing the effective launch of oncology biosimilars in the United States, including the struggle to garner market share and fighting patent litigation lawsuits across the country. They also report inadequate rollouts for the first wave of oncology biosimilars for AMGEN’s supportive care cancer drugs Neupogen, Epogen and Neulasta. 


“The promise of oncology biosimilars leading to an estimated $50 billion in market savings for oncology care is not going to happen unless the Biden Administration and Congress get involved from day one of the new administration. A major hurdle is when AMGEN and Genentech/Roche pay their competitors hundreds of millions of dollars NOT to market their biosimilar version of blockbuster cancer drugs — the so-called ‘Pay-for-Delay’ strategy. This strategy is not allowed with generic pharmaceuticals and extension of the end of this strategy for biosimilars under proposed bipartisan legislation led by Amy Klobuchar is imperative.”

-Y. Tony Yang, professor at the GW School of Nursing and Milken Institute School of Public Health 

“It is apparent that the intersection of law and medicine is proving to be a bigger hurdle than anyone anticipated for oncology biosimilars. Rather than patients having ready access to less costly formulations of blockbuster cancer drugs, ‘Pay-for-Delay’ deals and a bevy of patent lawsuits by AMGEN and Genentech/Roche hold the oncology biosimilar market hostage. Under the Biden Administration, dramatic changes in these barriers must occur if the U.S. is going to catch-up to the success that is seen in the European Union and Japan.”

- Charles L. Bennett, professor at the University of South Carolina College of Pharmacy


The Policy Review, “Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated Policy Review from the Southern Network on Adverse Reactions,” published on Nov. 30 in the journal The Lancet Oncology.

This work was supported by a National Institute of Health grant to Dr. Bennett’s Southern Network on Adverse Reactions (SONAR) program, a program that Bennett and Yang have collaborated on for a decade.

Journal Link: The Lancet Oncology