Last week, a US Food and Drug Administration (FDA) advisory committee gave a critical recommendation for a version of an expensive, branded drug used to treat a class of painful diseases.
The drug is a “biosimilar,” essentially a generic version of a biologic medicine produced by living cells.
Unlike generics for chemical-based drugs — think antibiotics or birth-control pills — that can be interchangeable with branded versions, the copycats of biologic medications, produced using living cells, have a few more caveats because the drugs might have different reactions in your body.
The independent panel voted 21-3 in favour of the drug, which would be an alternative to costly Remicade, a medication used to treat autoimmune disorders like rheumatoid arthritis and Crohn’s disease. The drug made $9.4 billion in sales in 2014. A company named Celltrion developed the alternative, which they’re calling Remsima.
The panel’s recommendation isn’t the final word on the drug; the FDA is expected to either approve or reject it in April.
An approval could be a huge deal. The US is getting hit with more costly — and typically more innovative — new drugs. To make up for the rising costs, something needs to change. Biosimilars could be that change, since they have the potential to compete with older, more expensive biologic drugs.
In Europe, this has already begun to take shape. Since 2006, more than 12 biosimilar medications have been approved there. But the US has been slow to follow.
“We are not trailblazers here. We are not even fast followers,” Steve Miller, the CMO of pharmacy-benefits manager Express Scripts said at a recent Bloomberg Intelligence event. “We’re real laggards when it comes to having biosimilars in the US marketplace.”
The delay could be wasting money — a lot of it. By some calculations, the US could be saving $250 billion over the next 10 years by introducing these drugs to the market.
Here are the main obstacles that biosimilars will likely have to overcome to begin to revolutionise medicine:
Roadblock #1: Making sure the drugs are actually ‘similar’
The name “biosimilar” refers to the fact that the new versions work in the exact same way as the original: not better, not worse. That way, even though the biosimilar won’t necessarily be interchangeable, it can still be just as effective at helping someone with a certain condition as the original would. That’s one of the biggest concerns Johnson & Johnson, the company that owns Remicade, has with a potential biosimilar version of its drug.
“We believe that the data … leave uncertainty about whether differences in safety or efficacy may emerge for patients.” Jay Siegel, Chief Biotechnology Officer and Head of Scientific Strategy and Policy at Johnson & Johnson said in a emailed statement to Business Insider after the FDA committee’s recommendation.
But the panel’s recommendation appears to take a different stance, suggesting that the data they do have is sufficient to show that the biosimilar version of the drug works just like the original, Remicade, in conditions like rheumatoid arthritis and ankylosing spondylitis. The committee also determined that the biosimilar had the potential to show that it works in other diseases currently approved to be treated with Remicade.
Roadblock #2: Cost
The FDA approved its first biosimilar drug back in March 2015.
The drug, called Zarxio, helps patients in cancer treatment fight infection, and has the same active ingredient as the biologic it’s similar to, called Neupogen.
But, Miller said, people aren’t buying it.
That’s in part because the drug was just a 15% discount off Neupogen’s list price. That wasn’t enough to get pharmacy-benefits mangers, which are responsible for negotiating prices of drugs between pharmaceutical companies and health insurers, to switch their plans to the new drug.
“For 15% off it’s just not worth it,” Miller said. Plus, he added, it’s only used for a short time. Biosimilars have a better shot in the chronic disease market.
If there’s a price point at which doctors are willing to start new patients on these drugs, then it’s possible it can help.
Roadblock #3: The patent dance
Patents — more than safety and efficacy of a biosimilar — may ultimately be the only thing that matters in terms of getting biosimilars on the market. Most biosimilars are being developed for drugs like Remicade, which is a TNF inhibitor that keeps inflammation at bay in people with autoimmune disorders. Because they’re so good at suppressing autoimmune disorder symptoms, they’re often quite expensive.
If drugmakers that own the original product are able to say that their patents hold water, it could still be years before the biosimilars — if approved — ever get to market. And how those patent disputes will go down remains to be seen.
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