What journalists and consumers should know about the tug-of-war between biologics and generic ‘biosimilars’

When the body attacks itself–known as an autoimmune disease–one of the most powerful drug options patients have is what’s known commonly as a “biologic drug.”

Custom prescription drugs being created in pharmacy compoundingIn the last few decades, these drugs, known medically as biologic response modifiers, have become key to helping people with disease like rheumatoid arthritis control inflammation that’s otherwise out of control. For this reason, they’ve also been huge money-makers for the companies that manufacture them. Biologics account for about a fifth of all drug spending in the U.S. and may reach $221 billion next year.

And now, with an estimated $71 billion in biologics expected to see their patents expire by 2020, the potential for a new cheaper market of “biosimilar” generic drugs is taking shape–one that many welcome to help lower the high cost of drugs in the U.S. (In the European Union, for example, biosimilars have been in use for a long time and they’re between 10 and 70% cheaper than their brand name counterparts.)

However, given the huge profit margins at play, this shift from biologics to biosimilars in the U.S. isn’t happening without a fight. Journalists and consumers need to focus a keen eye on the tactics being used by companies and industry groups to keep biosimilars from taking hold, as it can affect the accuracy of the news coverage.

Study shows biosimilars are interchangeable with biologics

But first, the science: While other common drugs are produced through chemical synthesis, biologics are genetically engineered proteins made from human genes. They are, in essence, manufactured in a living system, such as in plant or animal cells–and this requires a strictly controlled process that has to undergo hundreds of process controls. Are biosimilars manufactured in similar–but not exact–processes truly “generics” of biologics?

Until recently, that was a mostly open question–but a study published in the Annals of Internal Medicine sheds some light. The researchers, who conducted a meta-analysis of 19 different biosimilars, concluded that “preliminary evidence supports the biosimilarity and interchangeability of biosimilar and reference [biologics].”

Wait, what are biologics?

As lucrative as biologics are, most people aren’t really sure what they are. According to a 2015 survey, 80% of consumers failed to choose the correct definition of a biologic from a short list (see here), so it’s important to explain to readers what both biologics and biosimilars are when writing about them. The FDA’s Information on Biosimilars is a good place to start.

This study generated a fair bit of press including pieces in Kaiser Health News, StatNews, Consumer Healthday, UPI and International Business Times. The lead author of that study, Caleb Alexander, told UPI that it’s a “billion dollar question” around the equivalence of biosimilars yet “based on the available evidence, we conclude that the products we studied appeared comparable and they will definitely be cheaper.”  

This preliminary evidence is hardly the last word on the subject. And industry groups are likely to keep pushing back, looking for ways to keep biosimilars at bay no matter what the science says. 

They’ve done it before, after all, with regular generic drugs. As this National Post piece points out, the drug industry continues to fund a variety of “articles and talks aimed at doctors, pharmacists and drug-plan administrators” designed to cast doubts on generics, even though such doubts “have little or no basis in empirical evidence, and are belied by 50 years of almost trouble-free use of generic drugs,” according to academic pharmacologists.

“Companies will continue to use whatever legal remedies they have, as you’d expect when there are tens of billions of dollars at stake,” notes a Bloomberg story titled “With biosimilars, Big Pharma fights itself.”

It’s these remedies and tactics we want journalists and consumers to be on the lookout for:

Tactics to be aware of in the industry tug-of-war

Engaging in fights about how to label these drugs. Do biosimilars need an extended explanation on their drug label that they’re not really, truly an exact copy of the drug they’re meant to replace? Drug companies seem to think so, and the Boston Globe did a great job explaining why one doctor called out the “scare tactics” behind these name games and how they’re connected to company profits. This has direct patient impact: In some states, pharmacists will not be able to switch patients from a brand drug (example: Remicade) to a generic (Inflectra) and this lack of “interchangeability” and naming rules are at the heart of the potential costs savings around biosimilars.

The “patent dance.” According to Joseph Fuhr, an economist at Widener University and the co-author of this report looking at the economics of biosimilars, there are many issues that could tie up the biosimilars in litigation, especially the “patent dance.” Journalists should keep an eye out for the back-and-forth arguments that biologic makers and their biologic copiers will try to employ when fighting over market share. This issue underpins the heated debate around the 2010 Biologics Price Competition and Innovation Act (or Bio-similars Act) included as part of the Patient Protection and Affordable Care Act. It’s essentially a way to resolve patent disputes regarding biosimilars, but as this STAT piece points out, it’s not exactly settled, with even the Supreme Court now getting involved.

Questionable patient or medical “grassroots” groups (in news stories) to cast doubt on biosimilars or generics.  We’ve seen this before with other “astroturf” campaigns carried out by fake consumer or healthcare groups backed by powerful chemical, food or pharmaceutical corporations. One group, the Alliance for Patient Access, according to a Wall Street Journal post, is largely funded by pharmaceutical manufacturers–not patients, and they recently framed an FDA biosimilar labeling guideline they didn’t like as a patient safety issue.

With billions at stake, the drug industry can be expected to use its full arsenal of weaponry–including carefully honed legal attacks and sophisticated media disinformation campaigns–to protect its free-flowing biologic revenue streams. Journalists and consumers should be prepared for the onslaught.

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