Biosimilars caught up in patent wars
In 2016, Roche sold $3 billion worth of its blockbuster biotechnology drug Avastin. Last week, the Food and Drug Administration approved what’s expected to be a less-expensive version.
Patients and insurers won’t be able to count the savings any time soon.
Of seven biosimilar drugs the FDA has cleared since the first approval of one of the drugs in 2015, only three are available for sale. The rest are tied up in legal disputes that can block the cheaper versions for years.
“Basically, there’s a gazillion patents,” said Gillian Woollett, senior vice president at the consulting firm Avalere Health and an expert on the drugs. The makers of the original drugs are using those patents to keep competitors out. “You’ve got some extremely well-established products with substantial resources behind them.”
Congress created a path to market for biosimilars in 2010 as part of the Affordable Care Act. The goal was to give patients access to cheaper versions of costly drugs made from living cells. Generic versions of traditional pills can cost pennies on the dollar compared with brandname versions and have saved the nation’s health system $1.67 trillion in the last decade, according to the Association for Accessible Medicines.
Roche’s drug, Avastin, costs about $73,000 to $148,000 a year, depending on the type of cancer the patient has, according to the company. While biosimilars are expected to be less costly than the brands, they also require more testing and manufacturing resources, so won’t have the sharp price reductions of pill-form generics.
Getting the biotechnology drug copies to market isn’t just about getting them approved. Because of their complexity, biologic drugs can have more than 100 patents — which can be used to fend off competition. Often, the two sides will try to agree on which patents will be involved in initial litigation.
There have also been disagreements over what to call the drugs, how to market them, and when it’s appropriate to switch patients from one to another.
In other cases, drugmakers have used contracts with drug plans and insurers to thwart competitors. When Pfizer’s biosimilar version of Johnson & Johnson’s Remicade came to market, J&J made made exclusive agreements with payers to only cover its brand-name treatment.
The result has been lackluster sales of the new drugs, including Pfizer’s.
Last week, when the FDA announced the approval of Amgen’s version of the 13-year-old Avastin, it called the move “an important way to help spur competition that can lower health care costs and increase access to important therapies.”
Yet Amgen has not set a release date or a price for the biosimilar copy of Avastin, which will be called Mvasi. Kristen Davis, an Amgen spokeswoman, said Amgen and Roche are in the process of exchanging information about patents.
Roche said it supports biosimilars, but wouldn’t comment on any potential legal disputes.
“Patients’ interests have always been front and center for us, and we believe having more treatment options is a good thing,” said Meghan Cox, a spokeswoman for Genentech of South San Francisco, the Roche unit that makes the drug.
The FDA is trying to get doctors more familiar with biosimilars. It also is considering changes to draft guidelines on how makers of biosimilar drugs can prove to the FDA that doctors can switch patients from one drug to another.
FDA Commissioner Scott Gottlieb said the agency plans a campaign to educate physicians about the process that biosimilars go through.
The issue of patents and delays into getting the drugs to market is outside his agency’s purview, Gottlieb said.
Some of the delays come from the newness of the biosimilars law, said Chuck Klein, a lawyer with Winston & Strawn in Washington, who specializes in biotechnology and pharmaceutical. The hope is that, eventually, makers of brand-name biotech drugs and their potential competitors can work out legal issues in advance.
“Right now it’s a little weird but eventually it will fix itself,” Klein said. AbbVie makes the world’s best-selling drug, Humira, which had $10.43 billion in U.S. sales last year and treats immune system diseases. The drugmaker has erected a veritable fortress of patents.
While the main patent on the biotechnology drug expired last year, not a single competitor has been released.