Northwest Arkansas Democrat-Gazette
Avastin copy gets FDA OK, faces slog
In 2016, Roche Holding AG sold $3 billion worth of its blockbuster biotechnology drug Avastin. Last week, the U. S. Food and Drug Administration approved what’s expected to be a less-expensive version.
Patients and insurers won’t be able to start counting the savings anytime soon.
Of seven so-called biosimilar drugs that 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. He said the makers of the original drugs are willing to use those patents to keep competitors out. “You’ve got some extremely wellestablished products with substantial resources behind them.”
Congress created a path to market for biosimilars
in 2010 as part of the Patient Protection and Affordable Care Act. The goal was to give patients access to cheaper versions of costly drugs made from living cells, which until the law didn’t have a path for copycats. Generic versions of traditional pills can cost pennies on the dollar compared with brand-name versions and have saved the U.S. health system $1.67 trillion in the past decade, according to a report by 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 and 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. One step involved in getting the copycats to market is the “patent dance,” where the two sides try to agree on which patents will be involved in initial litigation. More lawsuits can be filed later.
There have also been disagreements around 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 Inc.’s biosimilar version of Johnson & Johnson’s arthritis treatment Remicade came to market, Johnson & Johnson made exclusive agreements with payers to only cover its brand-name treatment.
The end result has been lackluster sales of the new drugs, including Pfizer’s.
“A physician can’t just switch easily a patient to a biosimilar,” Umer Raffat, an analyst with Evercore ISI, wrote in a note Saturday.
On Thursday, when the FDA announced the approval of Amgen Inc.’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 no planned launch date for the biosimilar copy of Avastin, which will be called Mvasi. It also hasn’t named a price. Kristen Davis, an Amgen spokesman, said Amgen and Roche were 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 spokesman for Roche’s Genentech unit, which makes the drug. She added, “We plan to defend the patents protecting Avastin as we do for all of our medicines.”
The FDA, which has announced several measures on drug costs, is trying to get doctors more familiar with biosimilars. It’s also 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. Gottlieb didn’t specify what those changes could be.
“We’re going to be launching a public service campaign to educate physicians about the process biosimilars go through,” FDA Commissioner Scott Gottlieb said. The campaign will likely kick off in the next month or two, Gottlieb said.
The issue of patents and delays into getting the drugs to market is outside his agency’s purview, Gottlieb said.