Bioregnum, Biosimilars, Drug Development, Opinion

Why we need to lower U.S. regulatory barriers around biosimilar approvals now

The FDA’s internal review on Amgen’s biosimilar of Humira reads like a product endorsement. Posted on Friday, the agency insiders essentially said: Let’s give it a quick kiss on both cheeks and approve this knockoff. It’s good to go on every indication AbbVie has in the U.S., which is the lynchpin to its global, $14 billion franchise.

The legal war still has to play out, but the real lesson here is that now that the applications are coming, the agency experts are having no trouble recommending a green light to these biologic twins. The data packages they’re delivering are decisive. And years of watching lawmakers and regulators play a tug-of-war over the rules around biosimilar development have come down to this:

Biosimilars are a perfect multinational Big Pharma play. They build big Phase III studies for products they understand very well. It gives them an entrée into a big market with low risk, while a high barrier limits competition. Eventually, as they crowd into the market, they’ll push discounts to the jaw-dropping 75%-off levels predicted recently by Novartis’ Joe Jimenez, who ought to know.

These are all big steps. But there’s something missing here. Where’s the outcry from Congress for speeding up approvals?

New cancer drugs can’t come fast enough, as far as lawmakers are concerned. Many in Congress have said they would give Sarepta a hall pass on eteplirsen, on little to no evidence of efficacy. But low risk, cheaper versions of blockbuster drugs? They still face a considerable challenge. Why not find ways to lower some of the regulatory barriers, which were erected as a result of a vehement industry lobbying campaign?

I’m not saying that Congress should shorten biologics’ exclusivity period. That’s an important reward that has paid off with a new generation of biologics and an unprecedented level of competition in the marketplace – which is what you want to see. But easing regulations would seem to be a perfect bipartisan position. The rapid approval of a critical mass of competing biologics would have an immediate impact on multibillion-dollar franchises. Businesses are helped, competition is encouraged and prices are lowered faster.

There are plenty of vested interests which would like to keep the high barrier in place. But it’s time to catch up with Europe and change the regulatory game to favor biosimilars. In addition, you’d need to add patent reform to make it harder to prevent rivals from fielding biosimilars after the proper protection period has come to an end.

In this election year, that would be a strategic concession to populist outrage over drug prices. It also just makes sense.

The time has come.


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John Carroll, Editor and Co-Founder

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