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    Rituximab biosimilar prequalified by WHO

    The World Health Organization (WHO) has prequalified South Korean drugmaker Celltrion’s biosimilar version of rituximab, the second product achieving that status under a biosimilar prequalification pilot begun by the agency in 2018.   “Rituximab has revolutionized the treatment of diffuse large B-cell lymphoma, chronic lymphocytic leukemia and follicular lymphoma, significantly improving therapeutic responses, and remains a fundamental component of treatment regimens...
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    EMA official says COVID-19 vaccine could be approved in a year

    A vaccine against SARS-CoV-2, the novel coronavirus scourging the globe, could be approved in the European Union in about a year, Marco Cavaleri, the European Medicines Agency’s top official overseeing anti-infectives and vaccines, said Thursday.   Cavaleri cautioned that this is an optimistic view but said the ambition is to have a vaccine approved next Spring and that he is skeptical of claims that a vaccine could be ready by September .   “I have to stress that...
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    Purple Book: FDA adds transition biologics as move to single database progresses

    The US Food and Drug Administration (FDA) on Monday updated its searchable Purple Book database to include all biologics regulated by its Center for Drug Evaluation and Research (CDER) with the addition of products that transitioned from new drug applications (NDAs) to biologics license applications (BLAs) last March.   With the update, FDA also added the ability to download monthly reports that include a changelog detailing new and updated products from the previous...
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    Regulators urge RCTs with control arms for COVID-19 drug trials

    As no specific therapeutic has clearly demonstrated efficacy for treating COVID-19, more than two dozen pharmaceutical regulators around the world agreed in a virtual workshop last week that randomized controlled trials (RCTs), long considered the gold standard for clinical trials, will be necessary for approvals. The summary report of the meeting also stressed the need for COVID-19 drug developers to include an appropriate control arm (“i.e. not including antivirals or...
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    PDUFA, BsUFA resource capacity planning: Report recommends refinements

    A new report from Booz Allen Hamilton commissioned by the US Food and Drug Administration (FDA) recommends refinements to the agency’s workload capacity planning adjustment methodology for its prescription drug (PDUFA VI) and biosimilar (BsUFA II) user fee programs.   Background   A workload adjustment mechanism was first introduced under PDUFA III, as “a means to adjust the annual PDUFA target revenue to account for long-term changes in the volume of certain regul...
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    FDA Proposes New Rule on Allowing the Use of DMFs for Transitioning Biologics

    The US Food and Drug Administration (FDA) on Thursday proposed a new rule to allow certain biologics, originally approved under a new drug application (NDA), to continue relying on drug master files (DMFs) for certain information even after the NDA is deemed to be a license for a biological product on 23 March 2020. This so-called “deemed to be a license” transition next year, the details of which were explained in full last December, will mean that moving forward, fo...
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    FDA Proposes to Remove Mycoplasma Test Method

    The US Food and Drug Administration (FDA) issued a proposed rule on Monday to remove the required testing method to detect the presence of Mycoplasma because FDA said the regulation is restrictive in that it identifies only one test method to be used even though other methods may be appropriate. The proposed rule seeks to remove the testing method for Mycoplasma detection in virus harvest pools and control fluid pools of live and inactivated virus vaccines produced ...
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    House E&C Committee Addresses 7 Bills to Improve Generic Competition

    The House Committee on Energy & Commerce’s health subcommittee on Wednesday held a hearing to discuss seven bills that help generic drug companies gain access to samples for testing necessary to win generic approval, tweak parts of the 180-day exclusivity that first generic filers can win and make updates to the Orange Book of generic drug patents and the Purple Book for biosimilars. All seven bills are part of Congress’ attempt to bring more generic drug competition to...
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    FDA Reverses Course, Decides Not to Add Suffixes to Older Biologics’ Nonproprietary Names

    The US Food and Drug Administration (FDA) has decided not to go back and rename biologics’ nonproprietary names with nonsense suffixes, as it once said it would, raising questions about the confusion that will likely come from a subset of biologics’ and biosimilars’ names containing suffixes while another subset of biologics’ names will not contain suffixes. Since 2015, FDA has been adding the meaningless suffixes to biosimilars' nonproprietary names as part of an effor...
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    Regulatory Explainer: Everything You Need to Know About Biosimilars

    For more than a decade now, biotech and pharmaceutical companies have brought a new class of treatments – biosimilars – to markets around the world (from the EU to India to South Korea to the US), offering cost savings for some of the most expensive medicines, though even in 2016, decades after companies began their quest to develop biosimilars, they are still only just beginning to see widespread adoption. What is a Biosimilar? A biosimilar medicine (also sometimes k...
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    FDA Begins Adding Suffixes to Newly Approved Biologics' Names

    • 17 November 2017
    The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in policy from only adding the suffixes to biosimilars' nonproprietary names since 2015. The first additions of the meaningless suffixes came for Thursday's approval of Roche's Hemlibra (emicizumab-kxwh), one of the first new medicines in nearly two decades to treat people with hemophilia A, ...
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    Proposed and Final FDA Rules: What’s Left in 2017

    The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings. Proposed Rulemakings Among the proposals coming are rulemakings dedicated to pediatric study plan requirements , internal decision making and supervisory review at FDA’s Center for Devices and Radiological Health, the withdrawal of a regulation that a...