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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
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    FDA Approves Two More Biosimilars

    The US Food and Drug Administration (FDA) on Tuesday approved the 22 nd and 23 rd biosimilars: Pfizer’s Ruxience (rituximab-pvvr), which is the second biosimilar to Roche’s Rituxan (rituximab), and Samsung Bioepis’s Hadlima (adalimumab-bwwd), which could end up being the ninth biosimilar to AbbVie’s Humira (adalimumab). Ruxience is approved as a treatment of adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combin...
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    Six Lawsuits Target AbbVie’s Humira and its Patent Thicket

    The city of Baltimore, the largest grocery-worker union in New York and at least four other health plans have filed lawsuits against AbbVie over the past several weeks, alleging the Chicago-based company’s blockbuster Humira (adalimumab) should already have biosimilar competition in the US. One of the lawsuits, brought on by UFCW Local 1500 Welfare Fund, the New York grocery-worker union, argues that AbbVie should be held accountable for its thicket of patents and recen...
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    Mini-Exodus From Biosimilar Space Stirs Questions

    In just the past month, three companies have all exited the biosimilar space in one way or another, which has some questioning whether expectations for the biosimilars markets need to be adjusted. The slide began early last month when Sandoz halted its submission for biosimilar rituximab in the US after the Food and Drug Administration (FDA) requested additional information. Stefan Hendriks, global head of biopharmaceuticals at Sandoz, said he believes the needs of...
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    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...
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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 Approves First Treatment for Chronic Graft Versus Host Disease

    The US Food and Drug Administration (FDA) on Wednesday expanded the approval of AbbVie’s Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after the failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD. Background cGVHD is a life-threatening condition that can occur in patients undergoing hematopoietic stem cell transplantation (HSCT) for certain blood or bone mar...
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    UK Patients to Get Early Access to AbbVie's HCV Combo

    Patients in the UK will get early access to AbbVie's experimental pan-genotypic hepatitis C (HCV) drug combination, the Medicines and Healthcare products Regulatory Agency (MHRA) announced Wednesday. The combination, known as glecaprevir/pibrentasvir, is currently undergoing an expedited review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for its potential to treat patients across all six major genotypes of HCV, with or wi...
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    EMA Recommends Two Amgen Humira Biosimilars

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Thursday recommended eight medicines for approval, including two Amgen biosimilars for AbbVie’s blockbuster Humira (adalimumab). Amgevita and Solymbic are the first adalimumab biosimilars recommended for approval in the EU. Humira was first authorized in the EU on 8 September 2003. The EMA recommendations were announced on the same day AbbVie announced Humira sales of $16 ...
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    European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Updates Guidance on Determining Whether an app is a Medical Device The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance on determining whether an app is classified as a medical device. The new guidance features revised flowcharts to help software developers understand whether an app needs a CE mark. MHRA released ...
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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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    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...