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  • Regulatory NewsRegulatory News

    FDA Approves First Humira Biosimilar

    The US Food and Drug Administration (FDA) on Friday announced it had approved Amgen's Amjevita (adalimumab-atto), the first biosimilar version of AbbVie's best-selling biologic Humira (adalimumab). In July, FDA's Arthritis Advisory Committee voted unanimously to support the approval. Despite the approval, FDA did not clear Amgen's biosimilar for all 10 of Humira's indications. According to FDA, both drugs share the following six indications: moderately to severely a...
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    FDA May Push Back Release of Biosimilar Interchangeability Draft Guidance

    Although the Food and Drug Administration (FDA) has continued to say publicly that draft guidance on how an interchangeable biosimilar will be defined should come out by the end of 2016, the user fee reauthorization commitment letter released this week says the draft will publish sometime before 31 December 2017. The letter, which contains the performance goals and procedures for the Biosimilar Biological Product User Fee Act (BsUFA) reauthorization for fiscal years 2...
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    FDA to Hold One Advisory Committee for Each Initial Biosimilar

    The US Food and Drug Administration (FDA) on Tuesday clarified that it plans to hold only one advisory committee meeting for each of the first new biosimilars for a reference product, though it may hold more if there are particular issues or concerns with a specific biosimilar application. Marjorie Shapiro, chief of the laboratory of molecular and developmental immunology at FDA, told attendees at the annual PDA/FDA conference in Washington, DC, that the first biosimi...
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    Woodcock on Biosimilars: Earning the Trust of Prescribers and Patients is Key

    Similar to earning the public’s trust and confidence on generic drugs more than 20 years ago, the biosimilar industry needs to work to establish the same pattern of trust and confidence now, Janet Woodcock, director of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research, told attendees at the Generic Pharmaceutical Association’s (GPhA) biosimilar conference in Bethesda, MD, on Wednesday. Bluntly put, Woodcock said biosimilar and other indu...
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    Pharmaceutical Regulators Propose Principles for Indication Extrapolation for Biosimilars

    The International Pharmaceutical Regulators Forum’s (IPRF) Biosimilars Working Group (BWG) on Tuesday released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars. Background The IPRF was created as a safe harbor for discussion and promotion of harmonization among regulatory authorities and Regional Harmonization Initiatives (RHIs), including 11 regula...
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    FDA Approves Third Biosimilar in US, First for Amgen's Blockbuster Enbrel

    The US Food and Drug Administration (FDA) on Tuesday approved Sandoz’s biosimilar to Amgen’s blockbuster Enbrel, which will be known as Erelzi (etanercept-szzs) for all indications included in the reference product’s label. Erelzi is the second biosimilar approved via the Biologics Price Competition and Innovation Act in the US from Sandoz (the first was for Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen). The approval of Erelzi follows a unani...
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    Australia Outlines Major Drug Label Changes

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find. The changes, which will be implemented over four years beginning 31 August 2016, will be made available in Australia’s Federal Register of Legislation from 17 August 2016, along with guidance on how to apply the new labeling orders. T...
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    Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels

    Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...
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    MHRA Raises Concerns Over Improper Biosimilar Marketing

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday unveiled its misgivings with a two-day promotional meeting for UK health professionals on the Remicade (infliximab) biosimilar Remsima in Norway. The meeting, entitled “Norway inflammatory bowel disease [IBD] exchange,” was intended by the privately held, UK-based Napp Pharmaceuticals to promote Remsima from 11-13 October 2015 for UK healthcare professionals. The meeting was ruled in breach of...
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    FDA Staff: Sandoz’s Enbrel Biosimilar is ‘Highly Similar’ to Amgen's Blockbuster

    Another clear sign that the US biosimilars market is off to a good start appeared on Monday, with staff of the US Food and Drug Administration (FDA) concluding that Sandoz’s biosimilar, known currently as GP2015, and Amgen’s blockbuster Enbrel (etanercept) are “highly similar.” “In considering the totality of the evidence submitted, the data submitted by the Applicant [Sandoz] show that GP2015 is highly similar to US-licensed Enbrel, notwithstanding minor differences i...
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    FDA Staff Back Biosimilar to Compete With Blockbuster Humira

    Competition for one of the world’s top-selling biologics – AbbVie’s Humira (adalimumab) – is likely to come in the near future, as staff at the US Food and Drug Administration (FDA) said Friday that Amgen’s biosimilar has “no clinically meaningful differences” with the US-licensed Humira, in terms of safety, purity and potency. Amgen’s biosimilar will go before an FDA advisory committee next Tuesday, and if it is eventually approved (FDA has a deadline of 25 September 2...
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    Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness. The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but s...