Senate holds hearing on biosimilar agents with FDA's CDER director, some senators call for action

Issue: Premier Issue 2015

The Subcommittee on Primary Health and Retirement Security met on Thursday, September 17 for a hearing on the implementation of biosimilar agents with Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the FDA, and among other questions about interchangeability and safety, some senators questioned the lack of action in the issuance of guidance documents.

The hearing, moderated by Sen. William Cassidy, MD, (R-La.) included Woodcock as its only witness.

“FDA and I personally have long supported the availability of a biosimilar pathway,” Woodcock, a rheumatologist, said. She added that she has had an interest in biologics since the 1990s and has been involved in the development of biologics for over 30 years.

“Rooms full of wheelchairs are now a thing of the past in rheumatology clinics,” Woodcock said, and added surgery was once the only option to treat rheumatoid arthritis (RA).

“What I hear from some of my colleagues in rheumatology is that these transformative medicines are still inaccessible to some Americans because of the cost. Since the biosimilars pathway created by Congress in 2010, a lot of progress has been made ... but people are anxious to see more progress.”

Sen. Christopher S. Murphy (D-Conn.) asked if the guidance on interchangeability will be issued by the end of the year. Woodcock declined to provide a date and said there are complex, “multiple clearances involved” and more needs to be understood about potential unexpected immune responses in some patients.

Concern about the lack of clear labeling and naming convention guidance as a “costly delay” for patients was expressed by Sen. Tim Scott (R-SC). He also expressed concern about added complexity for physicians – already navigating an expanded coding system – that could create confusion around dispensing the intended product. Woodcock replied the timeframe to develop labeling guidance would be “as soon as possible” and added that dispensation will not be interchangeable, although the safety and efficacy may be.

Sen. Elizabeth Warren (D-Mass.) said eight biologic drugs account for 40% of all Medicare Part B spending, and that biosimilars could save $44 billion over the next 10 years. However, she said the history of generic drugs has shown that savings may not be realized until at least two manufacturers enter the market with the lower priced drug, but only once a known regulatory structure is in place.

“It has now been 5 years since congress has authorized the biosimilars pathway, but so far, the FDA hasn’t even produced a draft guidance describing the standard for an interchangeable biosimilar drug,” Warren stated. “In addition, the FDA has not issued guidance on how the products will be labeled, and has not finalized many other guidance documents that will help companies enter the biosimilar market, so can you help us understand why the FDA hasn’t completed this work in 5 years?”

Woodcock said there are 57 products in development and the agency has been giving “one-to-one” advice to the sponsors with 16 reference drugs.

Warren reiterated the question, and pressed Woodcock.

“The European Medicines Agency adopted a biosimilars pathway in 2003 and approved the first biosimilars in 2006,” Warren said, and added that Health Canada approved its first biosimilars in 2009. “The FDA is building on nearly a decade of experience with the European Union, experience with Canada, and yet 5 years have gone by and we still don’t have any of these guidelines yet, not even in draft form.”

To date, three final guidances have been issued, Woodcock said, including one she called the “foundational guidance” for the development of a biosimilar drug with the framework for manufacturers and developers.

Warren said more than a process needs to be in place.

“It is time now to get this done,” Warren stated. “The longer it takes you to set the rules, the longer that patients will be stuck with paying (for) only one very expensive option to treat their medical needs.

“There aren’t many things in Washington (D.C.) that most stakeholders on both sides of the aisle agree on and that people out in industry agree on, but I think that we all agree that it is time to get guidance documents”

Sen Mark Kirk , (R-Ill.) concurred with Warren.

“I agree with her feelings about how quick the Canadians and Europeans have been,” Kirk said. “I think that the U.S. should be able to keep up with those guys.” – by Shirley Pulawski

Reference : http://www.help.senate.gov/