• Regulatory NewsRegulatory News

    Will FDA Add Suffixes to Approved Biologics' Names?

    Back in January, the US Food and Drug Administration (FDA) finalized guidance on how biosimilars and their biologic reference products' names should include a four-letter, FDA-designated meaningless suffix attached at the end of the nonproprietary name. But between January and now, of the biologics and biosimilars approved, only the biosimilars' names have included the random four-letter suffixes. The discrepancy leads to questions of inequity between the two pro...
  • Regulatory NewsRegulatory News

    Interchangeable Biosimilars vs. Biosimilars: Experts Explain Guidance, Discuss Development and Uptake

    Interchangeable biosimilars are headed to the US market over the next several years and discussion of the incoming products kicked off both the Biosimilars Council's conference on Wednesday and RAPS' Regulatory Convergence on Monday. Leah Christl, associate director for therapeutic biologics at the US Food and Drug Administration (FDA), on Monday presented on a recently released FDA draft guidance for industry on interchangeability , outlining the studies necessar...
  • Regulatory NewsRegulatory News

    FDA Approves 6th Biosimilar in US, Second for Humira

    The US Food and Drug Administration (FDA) announced Friday that it has approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira (adalimumab). Cyltezo, which follows the approval of Amgen's Amjevita (adalimumab-atto) last September , has been approved for multiple indications (see link to label below), did not go before an FDA advisory committee and was not approved as an interchangeable biosimilar. How...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news. Ireland Starts Consultation on Biosimilar Policy, Immediately Receives Pushback From Industry Ireland has started a consultation on how to increase access to biosimilars. The delayed document calls for feedback on pharmacy-led substitution of biosimilars, quotas for use of biologic copycats and other ways to increase uptake, although doubts remain about whether the gove...
  • Regulatory NewsRegulatory News

    TGA Consults on Biological Naming

    Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems. According to TGA, the need for a naming convention that can differentiate biologics from their biosimilar counterparts stems from concerns that adverse events could occur when switching patients between products, though the agency says there has been little evi...
  • Regulatory NewsRegulatory News

    FDA Panel Unanimously Backs Avastin and Herceptin Biosimilars

    The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday unanimously backed the approval of biosimilar versions of two of Roche's top selling cancer drugs, Avastin (bevacizumab) and Herceptin (trastuzumab). In the morning session, ODAC members voted 17-0 in favor of approving Amgen's Avastin biosimilar candidate, ABP 215, for six of Avastin's indications. However, the committee did not consider whether Amgen's data would support a...
  • Feature ArticlesFeature Articles

    Biological Products and Biosimilars: Global Naming Debate

    This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety. Introduction Conventions and regulations for naming biosi...
  • Regulatory NewsRegulatory News

    FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years

    The launch of the US biosimilars market has been slow since the pathway for approvals was set up in 2010, with only five US Food and Drug Administration (FDA) biosimilar approvals , none of which have been approved as interchangeable biosimilars. And though FDA cannot disclose what applications have been submitted to the agency due to confidentiality issues, FDA’s biosimilars lead Leah Christl said last week at DIA’s annual conference in Chicago that she expect...
  • Regulatory NewsRegulatory News

    US Supreme Court: No Six-Month Wait for Biosimilars After FDA Approval

    The US Supreme Court on Monday ruled unanimously that biosimilar companies will not have to wait an additional six months after US Food and Drug Administration (FDA) approval before launching their new biosimilars. The case, pitting biologics manufacturer Amgen against Novartis subsidiary and biosimilar manufacturer Sandoz, attempted to clarify what’s known as the biosimilars "patent dance," which is the process by which companies must exchange and figure out the pa...
  • Regulatory NewsRegulatory News

    Biopharma Companies Take Issue With FDA's Draft Biosimilar Interchangeability Guidance

    Ahead of Friday's deadline for comments, a number of biopharmaceutical companies are seeking further clarification from the US Food and Drug Administration (FDA) on various aspects of the draft biosimilar interchangeability guidance. Background In January, FDA released its  draft guidance on biosimilar interchangeability  for consultation, noting that there is "no single data package that will work for all proposed interchangeable products." The draft calls on co...
  • Regulatory NewsRegulatory News

    Biosimilars in the EU: New IMS Report Shows Savings Through Competition

    A new report released Tuesday, prepared by QuintilesIMS at the request of the European Commission, found EU countries are saving lots of money from biosimilars even if market share is low. The report looks at the six classes of medicines in which biosimilars are approved, including epoetin, granulocyte-colony stimulating factor, human growth hormone (HGH), anti-tumor necrosis factor (anti-TNF), fertility and insulin products. With 28 biosimilar approvals, the EU i...
  • Regulatory NewsRegulatory News

    WHO to Begin Cancer Biosimilar Prequalification Pilot This Fall

    The World Health Organization (WHO) on Thursday announced it will invite biosimilar makers to participate in a pilot program to prequalify biosimilars of two top selling biologics this September in an effort bring lower cost versions of the products to low- and middle-income countries. The two cancer treatments—Roche's Rituxan (rituximab) and Herceptin (trastuzumab)—make the top ten list for highest grossing drugs worldwide and cost in the tens of thousands of dollars pe...