Learning From the Norwegian Experience With Biosimilars

Steinar Madsen, MD, medical director of the Norwegian Medicines Agency (NMA), shared lessons learned from the Norwegian experience with biosimilars in a Wednesday talk at the SMi Biosimilars North America conference.

Madsen opened his session by saying that, as a physician, “the most important thing is that I can treat all of my patients,” and noting that biosimilars have allowed for significantly increased access to biologics—especially anti—tumor necrosis factor agents—in Norway. “We start with the biological in an earlier stage than we previously did,” said Madsen, and added that “today, patients with [rheumatoid arthritis] get much better treatment than they did 10 years ago. That’s absolutely certain.”

Norway, which recommends switching to biosimilars—and provides strong financial incentives to health systems that switch to biosimilars—has been hailed as a model for the rest of the world. Yet prescriber acceptance and adoption of biosimilar therapies did not happen overnight. “I’ve been doing myth-busting,” Madsen said. “The most important myth is that the reference product is the gold standard. This was repeated to doctors again and again,” and physicians “were considerably influenced by the anti-biosimilar campaign.”

However, physician education, said Madsen, has ensured that Norwegian physicians are now widely aware of the batch-to-batch variability with biologics, and that biosimilars are non-inferior to their references. Patients, too, he said, have become less skeptical of these therapies as they see more patients gaining access to high-quality treatments.

Madsen had words of advice for US healthcare stakeholders—to whom he said, “You have the worst healthcare system in the world if you look at how much you spend on it,”—on the following topics:

Interchangeable Status

In Madsen’s view, the US emphasis on interchangeability of biosimilars with their reference products is unwarranted. The NMA’s official opposition on switching among products is that it is not only safe to switch from a reference product to a biosimilar, but that it is also safe to switch among biosimilars of the same reference. Further clinical studies on the matter, he said, are unnecessary.

Pharmacovigilance

The Norwegian approach to pharmacovigilance for biosimilars also stands in contrast to FDA policies. The FDA requires a 4-letter suffix, devoid of meaning, to be appended to the names of biosimilars in order to track any adverse events related to individual biosimilars. By contrast, Norwegian regulators have devised a soon-to-be-implemented system in which specific batches of products will be correlated with any adverse events or anti-drug antibodies using a unique number assigned to patient packages of drugs. These numbers will be automatically transmitted to patient’s health records when the biologics are dispensed to patients.

Pricing and Competition

Finally, Madsen told US biosimilar developers that, when determining how to price their products against reference products, “the magic [number] is 40%.” This discount, he indicated, is sufficiently aggressive to spur meaningful price competition.

However, because the US market stands in contrast to Norway’s tender system, where there is “no wheeling and dealing, no kickbacks,” Madsen added that the United States should implement restrictions on retroactive price-matching and the bundling of products to help preserve true competition in the market.