• Regulatory NewsRegulatory News

    FDA Likely to Require Substantial Clinical Data for Interchangeable Biosimilars, Lawyers Say

    The US Food and Drug Administration (FDA) is “almost certain” to require clinical data in order for companies to demonstrate interchangeability between a biosimilar and its reference product, though the question of how much data will be required is major factor in determining how quickly the US biosimilars market will take off, according to a new report from the law firm Goodwin Procter. The Biologics Price Competition and Innovation Act (BPCIA) of 2010 established th...
  • Regulatory NewsRegulatory News

    GPhA’s Biosimilars Council: BPCIA Provides 12 Years Exclusivity, Not 12.5

    The Generic Pharmaceutical Association’s Biosimilars Council is taking issue with a recent court decision that could effectively delay the launch of biosimilars in the US by an additional six months, according to an amicus brief. Background Under the Biologics Price Competition and Innovation Act (BPCIA) -- authorized as part of Obamacare -- biosimilars can be approved via an expedited pathway and then marketed after their reference biologics are exclusively marketed fo...
  • GMP Deficiencies in Spotlight in Warning Letters to Amgen, Baxter

    Life science manufacturing giants Baxter Healthcare and Amgen were each sent Warning Letters by the US Food and Drug Administration (FDA) in January 2014 chiding them for medical device manufacturing problems at their respective facilities. Amgen Letter The Amgen letter refers to a June 2013 inspection of the company's Thousand Oaks, CA facility where it makes three products: Prolia with prefilled syringe and manual needle guard Enbrel lyophilized vial and diluent ...
  • Amgen's Aranesp Target of OPDP Letter, Agency's Seventh in as Many Weeks

    Biopharmaceutical manufacturer Amgen is the latest company to receive an Untitled Letter from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), the latest in a flurry of letters sent by the office in recent weeks regarding allegedly deficient marketing practices. The 19 November 2013 letter to Amgen, made public on 22 November, references a direct mailer used by the company to market its anemia drug Aranesp (darbepoetin alfa). Regu...
  • UK: NICE Revises Guidance on Amgen's Denosumab

    The UK's National Institute for Health and Clinical Excellence (NICE) has reversed an earlier decision and now plans to recommend the use of Amgen's new cancer drug denosumab, used in the treatment of bone metastases from solid tumors, to the National Health Service (NHS). Physicians would be prohibited from prescribing the drug under the recommendation unless Amgen agrees to a cut in the price of the drug. The original recommendation not to use the drug was r...
  • Supreme Court Prepares to Hear Amgen's Challenge to Securities Fraud Lawsuit

    • 12 June 2012
    The Supreme Court of the United States (SCOTUS) said it agreed to hear a challenge from life sciences manufacturer Amgen regarding a lawsuit alleging the company inflated its stock price by misleading investors about the safety of its anemia drugs, Aranesp and Epogen. Amgen is reportedly contesting the class-action nature of the lawsuit, which it says could have the perverse effect of placing severe financial pressures on companies if allowed to stand. "At issue," expla...
  • House Goes After Pharmaceutical Companies, Seeking Info on PPACA Negotiations

    • 08 May 2012
    An investigation by the US House Energy and Commerce Committee that began in January 2012 continues to escalate, with members of the committee directly targeting pharmaceutical companies in an attempt to discover what went on between the Obama administration and the pharmaceutical industry during negotiations on the Patient Protection and Affordable Care Act in 2010, reports Bloomberg . Members of the House Energy and Commerce Committee oversee the healthcare sector, ...
  • Biosimilars Guidelines Attract Attention, Criticism

    As Genetic Engineering & Biotechnology News reported in mid-April, the US Food and Drug Administration's (FDA) draft biosimilar regulations attracted mostly negative comments . Now some companies are adding further commentary to the pile-and they're bringing up points of substantial friction with FDA. Pharmaceutical manufacturer Amgen told FDA regulators that "requiring the maintenance of biosimilarity over time would inhibit manufacturing and quality improvem...