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    FDA Raises Concerns With 505(q) Petitions

    In a report to Congress, the US Food and Drug Administration (FDA) took issue with a certain statute that requires FDA to prioritize petitions seeking to delay product approvals above other safety petitions that raise public health concerns. “FDA continues to be concerned that section 505(q) does not discourage the submission of petitions that are intended primarily to delay the approval of competing drug products and do not raise valid scientific issues,” the agency sa...
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    Pfizer Not Planning US Launch of its Second Remicade Biosimilar Approved by FDA

    The US Food and Drug Administration (FDA) late Wednesday approved the ninth biosimilar in the US and the third for J&J’s Remicade (infliximab). But Pfizer said it will not launch Ixifi (infliximab-qbtx) in the US as the company already has another Remicade biosimilar on the market, known as Inflectra (infliximab-dyyb) (the third Remicade biosimilar is Merck and Samsung Bioepis’  Renflexis  (infliximab-abda)). Pfizer spokesman Thomas Biegi explained to Focu s that Ix...
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    Updated: The 505(b)(2) Pathway and Why Some Follow-on Insulins Aren’t Yet Biosimilars in the US

    Why has the European Medicines Agency (EMA) approved follow-on insulin products as biosimilars while the US Food and Drug Administration (FDA) has not? A look at several recent examples shows what is happening and what will change in the US over the next several years. In September, FDA granted tentative approval for Sanofi’s Admelog (insulin lispro injection), a rapid-acting human insulin analog. On 11 December, Admelog received full approval from FDA. In the EU, howe...
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    CMS Revisits Biosimilar Payment Policy: Industry Comments Signal Expected Changes

    A tweak to a Centers for Medicare and Medicaid Systems (CMS) billing code system that could come later this week would have a big impact in making US biosimilars more competitive with their reference products. Background CMS' Medicare Part B program currently pays for biosimilars under the Physician Fee Schedule (PFS) based on the average sales price (ASP) of all biosimilar products within the same Healthcare Common Procedure Coding System (HCPCS) code, which means...
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    When to Submit an ANDA vs. a 505(b)(2) Application: FDA Discusses in Draft Guidance

    The US Food and Drug Administration (FDA) offers multiple abbreviated approval pathways for potential drug developers, and in new draft guidance released on Thursday the agency explains both the pathways where abbreviated new drug applications (ANDAs) and 505(b)(2) applications can be submitted. The draft highlights criteria for submitting ANDAs under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), petitioned ANDAs under section 505(j)(2)(C) ...
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    Asia Regulatory Roundup: India Orders J&J and Others to Maintain Output of Knee Implants (3 October 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Orders J&J, Other Device Makers to Maintain Output of Knee Implants The Indian government has ordered Johnson & Johnson and a clutch of other device makers to maintain output of knee implants at pre-August levels. Officials invoked the legislation to stop the companies from cutting production in response to the price ceiling the government brought into force in ...
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    Pfizer Sues J&J Over Contracts Blocking Remicade Biosimilars

    Pfizer on Wednesday filed a complaint in a US District Court in Pennsylvania alleging that Johnson & Johnson (J&J) is using "improper exclusionary tactics" to maintain dominance in the US market for its blockbuster Remicade (infliximab) despite recently introduced competition. First approved in 1998, J&J's tumor necrosis factor-inhibiting biologic is used to treat a range of immune-mediated diseases in almost 500,000 Americans, including for Crohn's disease, ulcerat...
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    Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Boehringer, J&J Pressure TGA to Bring ‘Out of Date’ Advertising Framework into Digital era Boehringer Ingelheim and Johnson & Johnson have called for the Australian regulator to bring its advertising framework into the digital era. The Therapeutic Goods Administration (TGA) stands accused of operating an out-of-date framework that has failed to adapt to the rise of ad...
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    Drug and Device Companies Offer Recommendations for FDA’s Combo Product Policy Council

    Johnson & Johnson (J&J), Allergan, Pfizer and industry group BIO’s suggestions to the US Food and Drug Administration’s (FDA) new Combination Product Policy Council released Monday build on efforts included in the 21st Century Cures Act and the new user fee agreements. J&J calls on FDA’s new council to address the process and principles for determining the primary mode of action with cross-center collaboration to ensure technical considerations are included in the dec...
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    505(b)(2) Approval Pathway: Not Necessarily Shorter Approval Times

    With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new drug applications (NDAs), the pathway has not led to shorter approval times, according to a recent analysis conducted by the Tufts Center for the Study of Drug Development. Background Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosme...
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    Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. J&J, Novartis and Pfizer Comment on TGA Risk Management Proposals Johnson & Johnson, Novartis and Pfizer say they are broadly in favor of the Therapeutic Goods Administration’s (TGA) proposed framework for risk-management plans, but have some specific suggestions as to how it can be improved. TGA released version 3.0 of its guidance on risk management plans for medic...
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    FDA Reiterates Concerns on Citizen Petitions Delaying Drug Approvals

    Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions. In 2015, FDA notes that it ap...