• Regulatory NewsRegulatory News

    CMS Shift on Biosimilar Reimbursement Under Part B: What to Expect

    The Centers for Medicare and Medicaid (CMS) last week announced a major shift in how it will reimburse for biosimilars under Medicare Part B, and though the agency and market might not see the full impact of the decision for another decade, experts explained to Focus what the change will likely mean in the near and long term. And though the predictions are largely hypothetical (since there are not currently multiple biosimilars for any reference biologic on the mar...
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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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    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...
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    WHO Will Hold Off on Using Biological Qualifiers for Biosimilars

    No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report. The US Biosimilars Council praised the WHO move , which follows the US Food and Drug Administration’s (FDA) use of a system in which biosimilar nonproprietary names come with a f...
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    Abbvie, Amgen Deal on Humira Biosimilars Likely to Cost CMS More Than $1B

    Late last week, Amgen and AbbVie settled litigation over when competition for the world’s best-selling biologic Humira (adalimumab) will hit the market, and for the US, the settlement decided on 31 January 2023, while the EU will see competition 16 October 2018. The deal between the two companies means that AbbVie’s Humira, which was first approved by FDA in 2002 and accumulated sales of more than $130 billion in its first 15 years on the market, will be on the U...
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    FDA Offers Draft Guidance on Statistical Approaches to Evaluating Similarity for Biosimilars

    The US Food and Drug Administration (FDA) on Thursday released another piece of the biosimilars puzzle for industry, offering new draft guidance on the type of information a sponsor should obtain about the structural/physicochemical and functional attributes of the reference product, how that information is used in the development of an analytical similarity assessment plan and the statistical approaches recommended for evaluating analytical similarity. The 15-pag...
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    European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Medtech Industry Pressures Brexit Negotiators to Maintain Existing UK-EU Relationship Leaders from three medical device trade groups have called for the UK to retain close ties to the EU after Brexit. The letter asks negotiators on both sides of the Brexit process to keep the UK in the CE-marking regime and for its national regulatory agency to formally take part in...
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    FDA Approves First Biosimilar Cancer Treatment

    The US Food and Drug Administration (FDA) on Thursday approved Amgen’s biosimilar to Roche’s cancer treatment Avastin (bevacizumab). Amgen’s biosimilar was approved under the brand name Mvasi (bevacizumab-awwb). FDA’s approval of Mvasi follows an advisory committee’s unanimous backing of the treatment and is based on review of evidence that included extensive structural and functional characterization, animal study data, human pharmacokinetic and...
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    WHO to Launch Pilot to Prequalify Biosimilars

    The World Health Organization (WHO) announced Tuesday that in October it will launch a pilot project for prequalifying biosimilars as part of its work to make some of the most expensive treatments for cancer more widely available in low- and middle-income countries. The first "Expression of Interest," according to WHO, will cover both rituximab (Roche’s Rituxan) and trastuzumab (Roche’s Herceptin), and will be published in October 2017. In Europe, there are five ...
  • 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...
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    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...
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    FDA Panel Backs Hospira's Epogen Biosimilar in 14-1 Vote

    The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) on Thursday voted 14-to-1 in support of approving Pfizer subsidiary Hospira's proposed biosimilar to Amgen's anemia drug Epogen (epoetin alfa) for all four of its indications. While Hopsira's epoetin alfa biosimilar has been approved in Europe since 2007, FDA rejected the company's first attempt at US approval in October 2015, just after Pfizer completed its acquisition of Hospira. At...