WASHINGTON — Food and Drug Administration Commissioner Scott Gottlieb on Wednesday accused drug makers who manufacture pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market, costing Americans billions.

The tactics — some of which Gottlieb will refer to as a “toxin” — have prevented other drug makers from launching biosimilar medicines, highly similar versions of the same drugs.

“The branded drug industry didn’t build its success by being business naïve. They are smart competitors. But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate,” Gottlieb said in a speech at the Brookings Institution. “Some of these tactics should be unacceptable to every member of the drug supply chain.”


Gottlieb’s harsh remarks came as part of a preview of a new “Biosimilars Action Plan” that the administration released Wednesday. But that plan does not focus on some of the anti-competitive tactics Gottlieb criticized, since the FDA doesn’t police intellectual property disputes or rebate agreements with other parties in the supply chain.

Instead, it summarizes a series of 11 steps the FDA will be taking to encourage the nascent biosimilars market, many of which the administration has already outlined in the past and some of which have been underway.

Some are aimed at making more efficient the FDA’s process for approving biosimilars and so-called “interchangeable” products — a separate, congressionally defined category of the comparable drugs. Others look at making the regulatory process clearer, or improving communication between doctors, hospitals, insurers, and others who need to understand how the drugs work.

It’s an attempt to help lower prices in an especially expensive category; less than 2 percent of Americans use biologic drugs, but they account for almost 40 percent of all prescription drug spending, and for 70 percent of the growth in drug spending between 2010 and 2015, as Gottlieb highlighted Wednesday.

In fact, Americans could have saved $4.5 billion in 2017 if all of the FDA-approved biosimilars were actually available in the United States, according to an analysis the agency conducted that Gottlieb said will be released “soon.” The launch of several drugs has been delayed because of litigation or other agreements. FDA based its estimates on the savings that have been achieved in other countries, where more biosimilars are already on the market.


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Among many of the proposals in the document, the FDA is looking at ways to let biosimilar manufacturers show that their products are nearly identical to the versions of the biologic drugs sold in Europe as opposed to the biologic drugs sold in the U.S. in their drug applications.

Gottlieb said earlier this week that, in some cases, the European and American versions might be made in the same factory, but the FDA isn’t allowed to publicly acknowledge that fact because it’s a trade secret.

“We’re looking at whether or not we can have data sharing agreements in place with the European regulatory authorities, and we can use that knowledge to allow biosimilar sponsors to use a European product as the reference product,” Gottlieb said Tuesday. “That could help them purchase the product more cheaply.”

PhRMA, the main lobbying group for drug makers, said it supports the administration’s efforts to foster competition and pointed to the potential savings from new biosimilars.

“While we are reviewing the proposals, we support science-based regulations that ensure patient safety and look forward to working with the administration and the U.S. Food and Drug Administration as additional guidance documents are issued,” a spokesman added.

Ike Swetlitz contributed reporting.

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  • While this statistic seems compelling – “Americans could have saved $4.5 billion in 2017 if all of the FDA-approved biosimilars were actually available in the United States, ” – something is missing. That savings is computed against what figure and what percentage does that saving represent? If total spend is currently is $450 Billion (2016 figure – CNBC), then 40 pct of that is $180 Billion USD. I will never see $4.5 billion USD personally, so I will agree that’s a lot but it represents a discount of ‘only’ 2.5% – scarcely impressive. Driving that spending level down to $175.5 billion USD doesn’t seem like much – “just sayin’ “

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