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    Biosimilar ‘Patent Dance’: Federal Circuit Rules 180-Day Notice is Mandatory

    The US Court of Appeals for the Federal Circuit on Tuesday affirmed a district court’s ruling that a biosimilar applicant must provide a reference product sponsor with 180 days’ notice before commercial marketing of a biosimilar begins, regardless of whether the applicant provided notice of US Food and Drug Administration (FDA) review. The ruling has major implications for when biosimilars can be launched and it follows the US Supreme Court’s request in late June that th...
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    Asia Regulatory Roundup: India Revises Draft Biosimilar Guidance (5 July 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Revises Draft Biosimilar Guidelines, Drops Allowance of Parallel Trials The Central Drugs Standard Control Organization (CDSCO) of India has revised its draft biosimilar guidelines published earlier this year. While most of the document is unchanged, CDSCO has made notable amendments on how clinical trials must be run and the situations in which comparative studies ...
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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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    FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

    The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for biologics and biosimilars. The document, first published 1 June , suggested a shift in FDA’s proposal on biologic and biosimilar naming as it altered the number of random suffixes proposed by developers (fro...
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    Biosimilars in the EU: Lower Costs, Increased Patient Access, IMS Report Finds

    For those tracking the contentious debate over drug and biologic price hikes in the US, an IMS Health report released on Monday offers the latest evidence yet that a robust biosimilars market can not only lower prices across drug classes but also increase patient uptake of such treatments. “The increased competition affects not just the price for the directly comparable product but also has an effect on the price of the whole product class,” the report says. “In countr...
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    ‘Truthful and Non-Misleading’: GOP Reps Take Issue With FDA’s Handling of Off-Label Marketing

    The tricky part about the off-label marketing of drugs, or the marketing of drugs to doctors for unapproved indications, is that companies, and not the US Food and Drug Administration (FDA), may get to decide what some courts are referring to as “truthful and non-misleading” marketing information. Republican Reps. Fred Upton (MI) and Joe Pitts (PA) on Thursday took FDA to task for the agency’s “inability or unwillingness to publicly clarify its current thinking” on off-l...
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    Arizona Becomes 21st State to Pass a Law Restricting Biosimilar Substitution at Pharmacies

    Arizona Gov. Doug Ducey (R) late last week signed into law a bill that would restrict which types of biosimilars pharmacists in the state can substitute biologics for. Hailed as a victory by industry group BIO , the law, like the 20 similar laws passed before it , is helping to create a patchwork of regulations governing how biosimilars are dispensed, even before biosimilars have hit the market en masse in the US. In the EU, however, the uptake of biosimilars, much l...
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    FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

    The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts. An FDA spokeswoman told Focus that the new date for the finalized rule is a “projected” date “that may be adjusted to reflect ongoing work,” though she could not offer any specifics on why this date was pushed back for this rule. The pro...
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    70 Groups Call on FDA to Revert Back to Meaningful Suffixes for Biosimilar Names

    The fight over how biosimilars should be named in the US isn’t over yet despite the US Food and Drug Administration’s (FDA) use of a non-proprietary name with a random suffix for the second approved biosimilar and plans to do the same for all future biosimilars. The group of nonprofits and other stakeholders, spearheaded by the Alliance for Safe Biologics, requested in a letter that FDA use meaningful suffixes for biosimilar non-proprietary names, such as the one used wi...
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    FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling

    The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product. At the outset of the 15-page guidance, FDA makes clear that biosimilar product labeling should not include a description of a clinical study that merely supports a demons...
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    IMS: Biosimilars Could Save Up to $110B in EU, US Through 2020

    With 56 new biosimilars in clinical development, IMS Consulting Group says in a new report that the biologic competitors could save health systems across Europe and the US as much as $110 billion through 2020. But the savings for both regions will vary considerably as payers have adopted a variety of approaches to encourage physicians to prescribe biosimilars, motivate manufacturers and require certain clinical evidence to support the prescribing of these treatments. Fo...
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    Transparency: What FDA Drug, Device Regulations are Coming Later in 2016

    As part of the US Food and Drug Administration's (FDA) overarching transparency initiative – what’s known as FDA Transparency Results Accountability Credibility Knowledge Sharing (TRACK) –  the agency offers a look at what to expect for upcoming proposed and final rulemakings, though the dates in the tracker do not necessarily guarantee the release of the rules. By 31 March, according to the TRACK database, the agency expects to release four final rules and three propose...