Woodcock Grilled by Senators Over FDA Lag in Implementing Biosimilars

CDER Director Janet Woodcock came under fire Sept. 17 from senators demanding to know why the FDA is years behind Europe and Canada in establishing a workable program for biosimilars.

Woodcock agreed that the most important upcoming tasks are issuing a final proposed rule on nonproprietary naming and draft guidance on labeling and demonstrating interchangeability. Yet she refused to give specific dates for release while testifying before the HELP Committee’s Subcommittee on Primary Health and Retirement Security (Generic Line, Sept. 2).

Sen. Tim Scott (R-S.C.), said he realizes that government moves slowly, but expected the FDA would have issued guidance on appropriate labeling much earlier.

Sen. Elizabeth Warren (D-Mass.), criticized the FDA for dragging its feet on guidance that could resolve important issues for companies, particularly since Congress authorized the biosimilars pathway nearly five years ago. She noted that the European Medicines Agency adopted a biosimilars pathway in 2003 and approved the first biosimilars in 2006, while Health Canada approved its first biosimilars in 2009.

The FDA is building on nearly a decade of experience from Europe and Canada, Warren said, insisting that it’s time for the agency to finalize the outstanding guidance documents. The longer it takes, the longer patients will be stuck with paying for only one expensive option, she said, adding that biosimilars could save an estimated $44 billion over the next 10 years.

“We have to get the science right,” Woodcock responded, emphasizing that the agency doesn’t want to have problems with the first biosimilars out of the block. The FDA has issued three final guidances, including a foundational guidance with the scientific framework, and five drafts, she told the lawmakers.

The agency also has been busy dispensing one-on-one advice to drugmakers, Woodcock pointed out. As of July 31, a total of 57 proposed biosimilar products for 16 different reference products were enrolled in the biosimilar product development program.

Jerry Clewell, associate scientific director at AbbVie, agreed that the FDA has to “get the science right.” Still, key questions on interchangeability and product labeling need to be answered in a manner that prioritizes patient safety, Clewell said.

The drugmaker has filed a citizen petition challenging the FDA’s approach to biosimilar labeling (Generic Line, Aug. 19). Woodcock told the Senate panel that the agency is evaluating the petition. — Jonathon Shacat



$1,097 $847


Subscribe to Generic Line and save $250 off the regular one-year price of $1,097 — plus receive a FREE copy of our webinar, Success Strategies for Biosimilars Approval: A Roadmap to the 351(k) Application Process — a $287 Value!

Key Benefits

LINKS TO KEY DOCUMENTS — Each issue provides you with links that support GEN's articles such as FDA guidances, warning letters, rules, full texts of proposed legislation and more.

FDANEWS DRUG DAILY BULLETIN — This daily email brings you important FDA and international regulatory, legislative and business news in the pharmaceutical industry.

ONLINE ACCESS — Consider our newsletter archive your personal library! Search your current issue — and hundreds of past issues — by keyword and relevancy.