• Regulatory NewsRegulatory News

    FDA Officials Share Best Practices for Biosimilar Development

    With industry interest in biosimilars continuing to grow, top officials at the US Food and Drug Administration (FDA) are urging sponsors to leverage agency advice and follow best practices to ensure the timely success of their biosimilar development programs. The regulators' advice comes as the agency and industry prepare for the next era of FDA's biosimilars program under the second Biosimilar User Fee Act (BsUFA II) . According to Leah Christl, associate director f...
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    BsUFA II: What’s Coming for Biosimilar Sponsors from FY 2018 Through FY 2022

    A host of biosimilar experts, industry representatives and US Food and Drug Administration (FDA) officials convened on Thursday to discuss the second iteration of the Biosimilar User Fee Act (BsUFA II) and iron out the specifics of how the program needs to adapt over the next five years as the number of biosimilar applications continues to increase. FDA Commissioner Robert Califf opened the public hearing with comments on how the agency is still trying to find the righ...
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    FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance

    Although the Food and Drug Administration (FDA) has continued to say publicly that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017. The letter, which contains the performance goals and procedures for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal years 2...
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    FDA Unveils User Fee Rates for FY 2017

    In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself. The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a timely manner. The solution FDA proposed was to collect fees fr...
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    Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

    As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016 . For an NDA not requiring clinical data or a ...
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    Biosimilar User Fees: FDA and Industry Reach Agreement

    The US Food and Drug Administration (FDA) and representatives of the biotechnology industry have reached an agreement on the second iteration of the Biosimilar User Fee Act (BsUFA II) following 14 meetings from March through May. Specifically, the two sides have settled on the draft commitment letter that represents the agreements made over the course of the negotiations, which initially began in December 2015. Similar to FDA's other user fee programs, BsUFA is a ...
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    Biosimilar User Fees: Public Meeting Kicks Off Negotiations for BsUFA II

    The US Food and Drug Administration (FDA) began negotiations on the second biosimilar user fee program on Friday with a public meeting highlighting some of the roadblocks the agency has seen so far and what remains to be done to help make the US biosimilar market more robust. The current legislative authority for the Biosimilar User Fee Act (BsUFA) expires in September 2017, so FDA has to work with a number of stakeholders (industry, patients, academia, etc.) to devise ...
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    Legislators Want to Exempt Much of FDA's Funding from Future Budget Cuts

    New legislation introduced in Congress would exempt nearly half of the US Food and Drug Administration's (FDA) budget from austerity measures meant to help balance the federal budget. Background The bill, the FDA Safety Over Sequestration (FDA SOS) Act would specifically exempt FDA's user fees from the effects of future budget sequestration . The user fees, which come from the pharmaceutical and medical device industries, are meant to help fund FDA's regulatory...
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    FDA Announces all User Fees to be Paid by Pharma, Device Industries in 2015

    The US Food and Drug Administration (FDA) has now released all user fee amounts for the coming 2015 Fiscal Year, including fees for medical devices, pharmaceuticals, generic drugs, biosimilar drugs, drugs compounded at outsourcing facilities, animal drugs and generic animal drugs. The current FY 2014 user fees are also displayed, as are fees from FY 2013, when most programs were overhauled under the Food and Drug Administration Safety and Innovation Act (FDASIA) . Thi...
  • Legislators to OMB: Sequestration of FDA User Fees Wrong, Should be Reversed

    Legislators in the House of Representatives seem to have a consistent message for the White House's Office of Management and Budget (OMB), the office which effectively sets and enforces policy within the executive branch: Stop holding the US Food and Drug Administration's (FDA) user fees hostage. Background FDA's funding comes from a variety of different streams. While it receives a substantial amount of funding from the congressional appropriations process, it also rec...
  • FDA Publishes All User Fee Rates for Fiscal Year 2014

    The US Food and Drug Administration (FDA) has just published the user fee rates set to go into effect for the coming 2014 fiscal year (FY), including those for pharmaceuticals, biosimilars, facilities, master files, generic drugs and medical devices. Background Since the early 1990s, FDA has become increasingly reliant upon user fees to fund its operations. Whereas before the agency relied almost entirely on federal funding to conduct its operations, now nearly all indu...
  • President Signs into Law Budget Bill that Restores FDA's Authority to Spend User Fees

    A new budget resolution passed into law by President Barack Obama on Wednesday will for the first time allow the US Food and Drug Administration (FDA) to spend tens of millions of annual user fees the agency had already been authorized to collect under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012, but had been unable to spend under its existing budgetary authority. Background The fees are responsible for funding a significant portion of ...