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Policy Briefing Calls for More Efficient Biosimilar Approval Process


An Atlantic-sponsored policy briefing with key stakeholders on the future of biosimilars examined the expected impact of President Trump’s policies on the future of the biosimilar industry, how changes in regulation will affect the number of biosimilars approved, and what impact these changes will have on ensuring that biosimilars are safe and accessible for patients who need them. The Washington, DC, briefing on March 15, 2017, included Rep. Michael Burgess, MD, R-Texas, and chairman of the House Energy and Commerce Committee; David Fox, partner in the law firm of Hogan Lovells; Len Lichtenfeld, MD, deputy chief medical officer of the American Cancer Society; and Jim Van Lieshout, vice president of Market Access and Pharmacy Strategy at Apobiologix.

Rep. Burgess, a physician, has been in Congress long enough to have experienced 2 previous iterations of the negotiations over the FDA user fee acts (in 2007 and 2012). Burgess’s description of his past experiences with the user fee negotiation process suggest there was “drama” and turbulence prior to each reauthorization, but he said that despite the friction and disagreements in those instances, the bills were signed, the work was done ahead of schedule, and the act was reauthorized for the next 5 years. Burgess noted that if there’s anything he can take away from his tenure on the Energy and Commerce Committee, it’s that members of Congress can occasionally put disagreements aside and do the right thing for the American people. For the Biosimilar User Fee Act (BsUFA) II to be renewed, Congress will again have to come to an agreement and sign off on it before the end of September 2017 when the current act expires. Uncertainty and friction is once again high in the Congress as a result of the proposed repeal-replacement of the Affordable Care Act (ACA) by the Trump administration, and the hiring freeze will complicate the FDA’s promise to increase staffing of the agency’s biosimilar review team. Rep. Burgess said Congress must aim for a July timeframe to sign off on the user fee act agreement because of FDA hiring practices and notifications.

Looking to the future, Rep. Burgess said he hoped the Biologics Price Competition and Innovation Act (BPCIA) will become more efficient in the next 5 years of BsUFA II, assuming it is renewed. He said the FDA was responsible for bringing about efficiency, however, not the Congress. “The user fee agreements are stuck between the agency and the industry, and the subcommittee’s role is to oversee and ratify that process if it’s found acceptable,” he said. “We can’t have members of Congress deciding which biosimilars get approved and brought to the market,” no matter how much frustration there is between representatives of the FDA and industry.

Burgess stressed that if biosimilars are going to make a difference, there must be more approvals. The FDA and industry can expect Congress to look for significant increase in biosimilar approvals on the next “BsUFA report card,” he said, and stressed that biosimilars are needed so more patients can be treated for less money, a goal that he will kept in mind in his Committee work.

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