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FDA takes aim at pharma’s biosimilar-delaying tactics

Ever-rising cost of insulins also to be targeted

FDA Commissioner Scott Gottlieb has repeated a warning that the agency will crack down on delaying tactics deployed by pharma to block cheaper biosimilar alternatives.

In a statement yesterday, Gottlieb highlighted one example of that activity, which is companies “using – and sometimes abusing – limited distribution systems” such as those deployed in Risk Evaluation and Mitigation Strategy (REMS) programmes.

He has spoken out repeatedly against anti-competitive tactics and pricing practices - unprecedented among FDA Commissioners - and is now promising to back up his words with actions.

He said there have been cases of biologic drug producers using these systems as an excuse not to supply biosimilar developers with the reference samples needed to carry out the necessary testing to support product marketing applications.


FDA Commissioner Scott Gottlieb

“ While the limited distribution programmes can have a role in promoting patient safety, too many branded products are still misusing these programmes as rhetorical smokescreens to hide anti-competitive behaviour,” said Gottlieb, warning: “We’re not going to be partners to these deceptions.”

The FDA has already published a ‘name-and-shame’ list of companies that block access to small-molecule generics using such tactics, and Gottlieb said the agency will be “focusing equal attention to these same potentially anti-competitive practices when it comes to biosimilar drugs.”

The obstructive practices were referred to as ‘gaming’ in President Trump’s blueprint document which was unveiled earlier this year, as part of a package of measures that are aimed at reducing medicine prices in the US.

In concrete terms, the FDA will now review upon request study protocols submitted by biosimilar developers to check they are offering equivalent safety protections to the REMS programme operated by the branded drug company. If needed, the agency would then be able to provide a letter to the brand owner indicating that failure to provide samples would be a violation.

“This is just a start,” said Gottlieb in the statement. “We’re going to be monitoring these markets. And we’ll be taking additional actions. We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the US, where prices may be cheaper and reference products more accessible.”

Reference pricing is one of the measures being considered in Trump’s plans for medicine price controls, and is anathema to pharma industry body PhRMA, which has claimed it amounts to “importing foreign price controls from countries with socialised health care systems that deny their citizens access and discourage innovation.”

Insulin action

Gottlieb is also planning to take action on high prices for insulin and other drugs such as human growth hormone which have seen their prices escalate in recent years. At the moment insulins are regulated in the same way as small molecule drugs. even though they are biologics, but that will change in March 2020 when they are reclassified.

That opens the door for the biosimilar approval route, and that’s important because it has been hard to bring a substitutable generic insulin to the market under the conventional drug pathway – in fact there ae no approved insulin products that can be substituted at the pharmacy level in the US at the moment.

“This is a watershed moment for insulin products, which millions of American take each day to maintain stable blood glucose,” said Gottlieb, who suggested the changes will mean “these products can be open to brisk competition from biosimilars.”

Article by
Phil Taylor

12th December 2018

From: Healthcare



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