In the latest dust up over naming biosimilars, a bi-partisan group of US Senators today is sending a letter to the FDA to demand the agency explain why a seven-year-old policy toward determining names has gone missing from its web site. And their missive, which questions whether agency policy has changed, arrives as a contentious debate over naming these medications intensifies on both sides of the Atlantic.
Yesterday, the World Health Organization held a widely anticipated meeting in Geneva to begin a review of the naming issue. And last month, the trade group for generic drugmakers in the US filed a citizen’s petition with the FDA to request that all biosimilars share the same international non-proprietary name (INN) as the reference drugs, or original biologics (back story).
As we have noted previously, brand-name drugmakers and biotechs want the FDA to ensure that every biosimilar has a unique non-proprietary, or generic, name that will distinguish the medicine from the original biologic. In their view, distinct names would lessen confusion in the marketplace and, therefore, ensure patient safety and are lobbying the WHO to change its guidelines (read here and here).
But generic drugmakers argue that the same policy that governs nomenclature for existing medicines should also apply to biosimilars and changing the current system that is used for drugs globally would confuse physicians. They also argue the bid for separate names is a "delaying tactic” designed to thwart competition, according to Hospira chief scientific officer Sumant Ramachandran (read here).
Until recently, though, the FDA had a policy statement dating back to 2006 that was posted on its web site indicating the agency backed the position taken by the WHO. The agency view appeared to underscore the same concerns expressed by generic drugmakers that INNs should not be used in ways or institute unnecessary changes that could jeopardize patient health.
“INNs for biologicals should not be used to imply product interchangeability in the absence of credible scientific evidence. Likewise, however, INNs should not be used to differentiate biological products with the same active ingredient(s) when credible scientific data demonstrate that no pharmacologically relevant differences exist,” according to the FDA statement (see page 1).
However, the Senators say that the FDA position recently disappeared from the agency web site and fear this indicates a change in policy and would undermine the intent of the Biologics Price Competition and Innovation Act, which was implemented in 2010 as part of the Affordable Care Act, even though the law does not specifically address biosimilar product naming.
“In crafting the BPCIA, the intent of Congress was to create a safe and competitive marketplace for biosilmiars, aking to the marketplace for generic drugs,” they write to FDA commish Margaret Hamburg and express concern that requiring different names for biosimilars would confuse physicians who may not readily access the correct safety data, leading to less substitution and higher health care costs (here is their letter).
“While not all biosimilars will be designation as interchangeable, it is essential that, once a biosimilar has such a designation, a unique name does not stand in the way of otherwise appropriate substitution,” the Senators continue. “Mandatory generic substitution is a common cost savings tool for public and private benefit providers and payers that we cannot afford to lose.”
They also argue that having unique INNs in the US would place domestic biosimilar manufacturers at a disadvantage and prevent them from extending their reach to foreign markets. “With biologics set to account for 75 percent of all US drug spending by 2020, we cannot overstate the importance of this concern to both health care access and the overall US economy,” they write.
And so, the Senators want to know why the policy was removed from the agency web site and whether this signals a change in policy. If so, they want the agency to explain what led to a policy change and how FDA officials went about making this decision. We asked the FDA for comment and will update you accordingly.
The Senators who sent the letter include five Democrats - West Virginia's John Rockefeller, New York's Chuck Schumer, Bill Nelson of Florida, Iowa's Tom Harkin and Ron Wyden of Oregon - and John McCain, the Arizona Republican.
"In order to improve access to and lower the cost of biologic medications, Congress created a new approval pathway for biogeneric drugs that resemeble products that are already licensed by the FDA," Schumer says. "The FDA needs to stay on track and preserve its naming policy instead of going in a different direction, which could confuse people and leave them without access to affordable biogenerics that treat a whole host of diseases."
[UPDATE: An FDA spokeswoman sends us this: "The FDA is currently considering the appropriate naming convention for biosimilar and interchangeable products licensed under the pathway established by the BPCI Act enacted as part of the Affordable Care Act. The FDA is carefully reviewing and considering the comments submitted to the biosimilar draft guidance and public hearing dockets.
"We will take into consideration all comments as we move forward in finalizing the draft guidance documents and in developing future policies regarding biosimilar and interchangeable products, including naming. Generally, content on our website is updated and moved to improve site usability and search functions. However, in this case we’re still looking into the matter and I can’t provide any additional details on the document at this point."]
Biosimilar substitution, by the way, has been the focal point of a multi-state campaign engineered by some biotechs to protect their franchises and draw clear lines for allowing substitution, even though the FDA has not yet approved a biosimilar or decided whether a biosimilar is interchangeable with a brand-name biologic. So far, the effort has been rejected in 10 states, most recently in California, and will soon be debated in Massachusetts and Pennsylvania (back story).
STORY ENDS HERE