FDA Commissioner Scott Gottlieb has taken a swipe at biologics developers who use unwarranted delaying tactics to block the launch of biosimilar competition, saying the approach has robbed US patients of billions of dollars in savings.
He said in a speech to the Brookings Institute this week that branded drugmakers “thwart competition by dangling big rebates to lock up payors in multi-year contracts right on the eve of biosimilar entry”, and file for “patent thickets that are purely designed to deter the entry of approved biosimilars”.
His remarks came after the introductio of the Biosimilars Action Plan, a new initiative intended to improve the efficiency of biosimilar development and approvals, make sure developers have access to clear scientific and regulatory guidelines and promote biosimilars to patients, healthcare providers and payers.
The action plan also pledges to improve market competition by stopping “gaming” tactics to delay competition, following on from similar measures introduced in May to promote competition in the generics market.
The FDA has just revealed an analysis based on experience in other markets suggesting that, if Americans had been able to buy all the approved biosimilars last year, they could have saved more than $4.5bn.
However, with just three of 11 biosimilars approved to date on the market, they are being denied that opportunity with manufacturers, pharmacy benefit managers, group purchasing organisations and distributors splitting “monopoly profits” rather than embracing biosimilar competition and lower prices.
“Biologic manufacturers have a right to defend their legitimate intellectual property interests, and we want them to continue to offer the benefits of improved versions of originator biologics,” said Gottlieb.
But long-dated contracts and volume-based rebating schemes that can encourage dysfunctional treatment pathways, for example by payers that are requiring step-therapy or prior authorisation on the reference biologic before patients can access a biosimilar, are “unacceptable tactics”, he added.
“The generics market that we see today, while not perfect, is robust in most respects. But it took about two decades to develop,” said Gottlieb.
“Sometimes it feels as if we’re seeing the biosimilars version of ‘Groundhog Day,’ with brand drug makers replaying many of the same tactics, and all of us being too susceptible to many of the same misconceptions about biosimilars’ safety and efficacy relative to originator biologics.”
He highlighted some specifics from the Biosimilars Action Plan make the biosimilar development process more efficient, including making it possible for developers to reference non-US comparator products, which can lower the cost of clinical trials.
The agency is also looking at the possibility of allowing ‘carve-out’ biosimilar approvals where the branded product developer has lost patent protection for some indications but not others.