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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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    European Regulatory Roundup: House of Lords Backs Change to Drug Pricing Bill to Appease Pharma Industry (16 February 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Biosimilar Trade Group Pressures Ireland to Boost Access Ahead of Policy Shift Medicines for Europe has called on Ireland to adopt policies that increase uptake of biosimilars in the country. The lobbying effort comes in the run up to publication of a government consultation document on the legal actions Ireland needs to take to encourage greater use of biosimilars. B...
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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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    European Commission Offers New Q&A on Biosimilars

    The European Commission on Monday unveiled a new question and answer document for those looking to better understand biosimilars. Similar to the Focus  explainer on biosimilars , the 9-page EC explainer, available in seven languages, offers a quick 10,000-foot view of the biosimilars landscape, answering questions that patients might have on what a biologic is, what a biosimilar is, how biosimilars compare to generics, what types of studies biosimilars must undergo pri...
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    US Supreme Court to Review Biosimilar ‘Patent Dance’

    The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. The decision will not only have an impact on how biosimilar developer Sandoz and biologics company Amgen move forward in their interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but on the US biosimilar industry as a whole. T...
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    FDA Finalizes Guidance on Clinical Pharmacology Data to Support Biosimilars

    Between Christmas and the beginning of 2017, the US Food and Drug Administration (FDA) finalized guidance from 2014 to help biosimilar sponsors understand what clinical pharmacology data is necessary to support a proposed biosimilar. The 18-page guidance is one in a series implementing the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that established a pathway for the approval of such follow-on biologics. Four other final guidance documents and two o...
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    Lessons Learned from Biosimilar Drug Development

    This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development. Introduction The US biosimilars market is at an interesting juncture, with one product launched (Sandoz's filgrastim biosimilar, Zarxio)...
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    EMA to Launch Tailored Biosimilar Scientific Advice Pilot

    The European Medicines Agency (EMA) on Friday announced that it will launch a tailored scientific advice pilot project in February 2017 to support the development of new biosimilars. The tailored procedure will advise developers on the studies they should conduct, based on a review of the quality, analytical and functional data they already have available (standard  scientific advice  does not include the assessment of existing data). EMA plans to run the pilot until ...
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    Global Developments of Biosimilars

    This article was developed from presentations at the 2016 RAPS Regulatory Convergence meeting held in San Jose. The session titled "Biosimilars," was led by Arpita Shah, PharmD, senior manager, regulatory intelligence and policy, Celgene Corporation. Speakers included  Leah Christl, associate director, therapeutic biologics, FDA, CDER, Sabine Haubenreisser, MSc, PhD, EMA liaison official at the FDA and Tara Sanderson, associate director, project manager, CMC regulatory a...
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    US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches

    With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. “The proper interpretation of those provisions has a significant impact on the operation of the BPCIA [ Biologics Price Competition and Innovation Act of 2009 ] and the ability of aBLA...
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    Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway

    Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away. “I can imagine this provision will be carved out, if you will…part of the problem with the ACA [ Affordable Care Act ] is that it became so big that it was hard to totally ...
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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...