Members of a Senate Health, Education, Labor and Pensions subcommittee Thursday urged the Food and Drug Administration to set biosimilar rules to avoid the kind of challenges generic drugs faced when introduced to the market three decades ago.
Speaking before the subcommittee, Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said the agency was “on track” to issue guidance on the interchangeability and labeling of biosimilars by the end of the year. She would not, however, say definitively when they could be expected.
“We are working very hard to get them out,” Woodcock said before the panel. “But I never give a date because it's sort of out of my hands, there are multiple clearances involved and these are very complex.”
Woodcock stressed how only careful review of biosimilar products could assure providers and patients that the drugs were as safe and effective as the original biologic medications they copy. She drew a parallel to the regulatory standards facing generic chemical drugs when they were first introduced to the market in the 1980s.
“Our generics program is now hugely successful, with over 85% of dispensed prescriptions in the United States being generic drugs,” Woodcock said. “But this success did not happen overnight, it has been the work of many decades developing both maturity in the industry and gaining the confidence of the healthcare community to use generics.”
A 2014 report by the RAND Corp. estimated that biosimilars could save $44 billion over the next 10 years, as patents for many of the top-selling biologic drugs are set to expire over the next few years.
Criticism of biosimilars centers on the fact that unlike generic drugs, biosimilars are not identical to the original biologic drugs they copy, either in composition or production.
That variance has been the focal point in the debate over interchangeability, or the ability to switch a patient onto a biosimilar drug from an original biologic, and vice versa, without any added safety risk.
Critics, including a number of pharmaceutical firms and professional physician organizations, say not enough is known about the effects biosimilars may have on the body's immune response to say whether such products could be interchangeable with biologics.
The FDA has been working on guidance that would detail how the agency will demonstrate biosimilars' interchangeability to a reference product. Many experts say that interchangeability is key to the success of biosimilars.
Naming of biosimilars has been another controversy, with critics saying different names are necessary to avoid confusion among physicians and pharmacists and prevent adverse reactions.
Supporters contend biosimilars should carry the same name as their brand-name counterparts in order to lessen confusion about the safety and efficacy of such products.
In August, the FDA issued draft guidance that would require biosimilars and brand-name biologics to carry a four-letter unique suffix on the nonproprietary names they share, seen by many as a compromise between the two sides.
A critic of the FDA's delay in issuing additional guidance is Sen. Elizabeth Warren (D-Mass.), who said the agency has had five years since biosimilars received a pathway for FDA approval in 2010 with the passage of the Biologics Price Competition and Innovation Act. She said any further delay could hinder the potential for biosimilar to provide savings on drugs prices.
“It is time now to get this done,” Warren said to Woodcock. “The longer it takes you to set the rules, the longer that patients will be stuck with paying only one very expensive option to treat their medical needs.”
In a statement, Jerry Clewell, associate scientific director at pharmaceutical firm AbbVie, which produces some of the biggest selling and most expensive biologics on the market, said it was crucial to get the science around biosimilars right before decisions are made that could put patient safety at risk.
“It is clear that key questions related to interchangeability and product labeling remain unanswered, and need to be decided now and in a manner that prioritizes patient safety,” Clewell said.