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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    Sandoz Petitions Supreme Court to Rule on Biosimilars

    Novartis' Sandoz has called on the US Supreme Court to review a lower court ruling that found biosimilar makers must wait an additional six months after US Food and Drug Administration (FDA) approval before they can bring their product to market. The petition for the Supreme Court’s review deals with Sandoz’s Zarxio (filgrastim-sndz), which came to market as a biosimilar version of Amgen’s Neupogen (fligrastim). Although FDA approved Zarxio in March 2015 as the first bio...
  • Regulatory NewsRegulatory News

    FDA's Woodcock to Senators: Need to First Get the Science Right on Biosimilars

    One of the most important parts of launching a robust US biosimilar market and setting up the regulations to support it is to make sure the scientific framework is "bulletproof," Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), told senators on Thursday. Speaking as the sole witness before the Senate Subcommittee on Primary Health and Retirement Security, Woodcock touched on a number of yet-to-be...
  • Regulatory NewsRegulatory News

    Zarxio, First Biosimilar Approved in the US, Added to FDA's New 'Purple Book'

    Slowly but surely, the US Food and Drug Administration (FDA) is making quiet but substantial updates to its new "Purple Book"— a list meant to describe the degree to which a biosimilar drug is equivalent to the biologic product it references. Background FDA first launched its Purple Book in September 2014 in anticipation of the impending approval of several new "biosimilar" products. The first of those biosimilars, Zarxio (filgrastim-sndz), was approved on 6 March 2015....
  • Regulatory NewsRegulatory News

    FDA Approves US' First Biosimilar Product, but Regulatory Questions Remain

    The US Food and Drug Administration (FDA) has announced the landmark approval of the US' first biosimilar product, Sandoz' Zarxio (filgrastim-sndz), a drug biologically similar to Amgen's Neupogen. The product is the first to be approved under the 351(k) biosimilar pathway, which was first established under the Patient Protection and Affordable Care Act —Obamacare—in 2010. The approval of Zarxio, which is marketed in several other markets under the brand name Zarzio,...