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    Fast Start for FDA Drug Approvals in 2017

    The US Food and Drug Administration (FDA) is poised to make a comeback from the relatively low number of new drugs approved in 2016, though it's unlikely to match the approval highs from 2014 and 2015. Already in 2017, FDA has approved 14 new drugs , though that quick pace is not likely to continue and the rest of the year is shaping up to be an average or slightly above average year for approvals. Based on data from BioPharmCatalyst , FDA has just over 20 remaining a...
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    FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix

    The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names. “This week’s biologic, [ Valeant Pharmaceuticals ’] Siliq (brodalumab) was licensed under section 351(a) of the Public Health Service Act , and thus is within the scope of our recently ...
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    AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars

    Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week. “Retroactive application of the naming policy not only is unnecessary ‘for the proper performance of the functions of the agency,’ but it also is likely to undermine FDA’s objectives in adopting ...
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    WHO Releases Draft Guidance on Postmarket Changes to Biologics

    The World Health Organization's (WHO) Expert Committee on Biological Standardization (ECBS) recently released a new draft guideline detailing the agency's proposed approach to handling changes to approved biologics and biosimilars for public comment. Specifically, the guideline, which covers both biologics (referred to as biotherapeutic products) and biosimilars (referred to as similar biotherapeutic products (SBPs)), details the procedures and data requirements for a ra...
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    Biosimilar Interchangeability: ‘Careful What You Wish For’

    As the open question around interchangeable biosimilars in the US continues to drive the discussion on what the US Food and Drug Administration (FDA) will require for such a designation, some experts are saying the designation might not actually be that important for the biosimilar market as a whole. Ronny Gal, senior analyst in specialty pharmaceuticals equity research at Sanford Bernstein, told attendees at GPhA’s first biosimilars conference on Thursday that although...
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    Pharmaceutical Regulators Propose Principles for Indication Extrapolation for Biosimilars

    The International Pharmaceutical Regulators Forum’s (IPRF) Biosimilars Working Group (BWG) on Tuesday released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars. Background The IPRF was created as a safe harbor for discussion and promotion of harmonization among regulatory authorities and Regional Harmonization Initiatives (RHIs), including 11 regula...
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    BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years

    Rep. Jan Schakowsky (D-IL) and three Democratic colleagues in the House took a jab at the biotech industry on Thursday, introducing a new bill that would reduce the amount of exclusivity for biologics from 12 years to seven years. The introduction of the politicized bill comes as President Barack Obama has been pushing to lower the exclusivity threshold since at least 2010, though none of those plans have materialized. However, Obama also supports the Trans-Pacific Partn...
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    FDA Offers New Guidance on Interpretation of BPCIA

    The US Food and Drug Administration (FDA) on Friday released draft guidance on its interpretation of the "deemed to be a license" provision of the Biologics Price Competition and Innovation Act (BPCIA) of 2010. Put simply: FDA will not approve any pending or tentatively approved application for a biological product under the Federal Food, Drug, and Cosmetic (FD&C) Act after 23 March 2020.  The provision in the BPCIA states that: "An approved application for a biologi...
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    Woodcock: FDA Needs More Funds for Biosimilar Review Program

    Shuttling back and forth between two different House committee hearings on Thursday, US Food and Drug Administration’s (FDA) CDER Director Janet Woodcock made clear in a later hearing on biosimilars that the agency needs Congressional appropriations to properly run its biosimilar review program. When the Biologics Price Competition and Innovation Act (BPCIA) was enacted in 2010, FDA received no additional congressional appropriations to run the program, Woodcock said, fo...
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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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    CBER Touts Performance, Contributions to Public Health in FY2015

    The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) says it met or exceeded its performance goals for FY2015, according to a new report. Notably, the FY2015 Report from the Director will be the last under CBER Director Dr. Karen Midthun's leadership. Midthun is set to retire at the end of 2015, ending her 22 year career at FDA. As in previous years, CBER met or exceeded the performance goals for product reviews established b...
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    TPP, WTO Deals Reveal Strength of Pharma Industry’s Negotiating Power

    After five years of negotiations, the release of the final text of the long-awaited trade deal, known as the Trans-Pacific Partnership (TPP), on Thursday, as well as concessions made to the US in the WTO’s TRIPS (trade-related aspects of intellectual property rights) deal announced Friday both offer new insight into the strength of the pharmaceutical industry’s lobbying and negotiating powers. TPP Early last month, a number of questions emerged over a sticking point ...