If the announcement by the Swiss pharmaceutical giant Novartis holds true, biosimilars that the company plans to launch over the next 4 years could create a significant dent in the sales of 5 blockbuster molecules in the oncology and immunology space.
In an interview with Reuters, Richard Francis, who heads Sandoz, the generic unit of Novartis, said that biosimilars of Humira (adalimumab), Enbrel (etanercept), Neulesta (pegfilgrastim), Remicade (infliximab), and Rituxan (rituximab) could be expected to enter the market over the next 4 years. “We think we can become a real partner for payers and health care systems in making sure they can manage their budgets,” Francis said. These 5 drugs raked in $44 billion in sales in 2015 alone. A report
released by the IMS Institute for Healthcare Informatics earlier this year estimated the savings from an increased acceptance of biosimilars across Europe and the United States could reach as much as $110 billion through 2020.
A decade after having launched the world’s first biosimilar product, Omnitrope—a growth hormone replacement therapy—Sandoz has announced
plans of 11 biosimilar filings by the end of 2017 in both Europe and the United States.
Novartis of course faces significant competition
in this race from several pharmaceutical companies such as Amgen, Boehringer Ingelheim, Merck, Novartis, and Pfizer. Merck’s first biosimilar product etanercept, was approved in South Korea late last year, and the company has 4 other biosimilars in phase 3. Amgen has 9 biosimilars under development.
While the healthcare systems in Europe have integrated biosimilars into mainstream medicine, convincing providers in the United States to adopt to these products has proved to be an uphill battle. The biopharma development head of Sandoz, Marc McCamish, told Reuters that when doctors in the United States hear regulatory terms like “highly similar,” many of them interpret it as the drug being different. “Those are terms we constantly have to fight,” McCamish said. This could explain why Zarxio, the company’s biosimilar to Amgen’s Neupogen, approved in Europe a decade ago, arrived in the United States
only last year.
But efforts are underway to familiarize prescribers to this class of products. At this year’s annual meeting of the National Comprehensive Cancer Network (NCCN) in Hollywood, Florida, a special session
was organized to explain the nuances of biosimilars to what was primarily a provider audience. Andrew D. Zelenetz, MD, PhD, a medical oncologist and vice chair of medical informatics, Department of Medicine Memorial Sloan Kettering Cancer Center, a presenter at the session, said, “Biologics are expensive and the therapeutic spending in oncology dominates all of medicine’s spending. The extremely high prices of most biological products has forced us to look for options.”