Biologic medicines—drugs with complex molecules developed in living cells—have saved lives and improved the quality of life for millions of Americans. Yet despite their value, problems in the industry are driving up the cost of these already expensive medicines.
Just as less complex drugs have generic versions, biologics have biosimilars. But despite the fact they are just as safe and cost less biosimilars are rarely actually dispensed to patients. One barrier to biosimilar uptake is perception. Despite extensive evidence of safety and efficacy, many physicians have been slow to embrace biosimilars. The Food and Drug Administration (FDA) can help address this in a couple of ways. First it can help to increase public awareness—and physician awareness—of the safety and efficacy of biosimilars. In particular, focus should be put on the fact that biosimilars are no more different from the reference product than one branded batch is from another.
Each batch of biologic medicine has slight variations, even when produced by the same company. For a biosimilar to receive FDA approval it must be manufactured to the same standards as any batch of the original product.
Additionally, The FDA should also drop its naming convention that tags biosimilars with unique suffixes. By giving biosimilars a unique 4-letter suffix that originators don’t share, the FDA’s naming makes them look “different” or second tier, subtly signaling to clinicians and patients that they’re less trustworthy than the brand. The U.S. is the only country that does this, needlessly stigmatizing them. We don’t do this for small-molecule generics; we shouldn’t do it for biosimilars.
Perception isn’t the only problem. PBMs employ strategies that disadvantage biosimilars relative to brand name biologics. A recent House report found PBMs manipulate formularies—the lists that determine what patients and insurers pay—so biosimilars as priced the same as, or higher than, brand name biologics. Almost half of health plans fail to cover a Humira biosimilar despite four having interchangeable status—the FDA’s stamp of approval for switching a patient from a name brand to a biosimilar. That is unsurprising given PBMs help decide which drugs get covered and make more money off higher-priced drugs.
Manufacturers can also extend their monopoly on a drug through sprawling patent portfolios. Humira is the poster child: since its first 1994 filing, it has amassed more than 130 additional patents on the same product, delaying biosimilar entry five years in the U.S. compared to the EU Enbrel followed a similar path. Its original patent was granted in 1990 and due to expire in 2010, however, it still has active patents that extend its exclusivity to 2029, nearly twice the length of the original patent.
Many of the additional patents are filed for therapeutically insignificant reasons yet still keep biosimilars off the market. Even frivolous claims are expensive to fight. Challenging dozens—sometimes more than 100—patents adds massive expense and risk to biosimilar production. Developing a biosimilars takes six to nine years and hundreds of millions of dollars to develop, plus hundreds of millions more for switching studies to secure interchangeable status with the FDA. While the FDA has proposed a pathway that avoids routine switching studies, it is not yet finalized. This investment becomes remarkably less viable if it is going to have to challenge dozens of patents or settle the challenge for delayed market entry.
Fixing the patent abuse and unnecessary switching study costs would help level the playing field. Right now, the U.S. trails Europe on biosimilar access. The EU treats all biosimilars as interchangeable and has 120 interchangeable biosimilars—nearly 5 times more than America’s 21. Of 118 biologics losing patent protection by 2034, only about one-tenth have a biosimilar in development. Given litigation risk, PBM practices, and lingering skepticism among clinicians and patients, it is no wonder companies hesitate to invest.
Biologics save lives, but today’s rules and market games keep prices high and patients waiting. The FDA should end its stigmatizing naming and finalize interchangeability guidance that eliminates redundant switching studies. Congress should curb patent gaming by requiring demonstrated therapeutic improvement for new patents on existing products and capping how many patents brands can assert when challenging a biosimilar. The Federal Trade Commission and state attorneys general should challenge PBM formulary tactics that block lower-cost competition and Congress should mandate greater transparency for PBMs.
If we act now, we can stop falling behind the rest of the world, save lives, and reduce drug costs for patients without risking their health.
