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  • Regulatory NewsRegulatory News

    Amgen, Astellas Pay $125M to Settle DOJ Kickback Allegations

    Two more pharmaceutical companies on Thursday joined a heap of peers in settling allegations made by the Department of Justice that the companies used foundations to pay Medicare copays for their own products. Amgen and Astellas Pharma agreed to pay $124.75 million total ($100 million for Astellas and $24.75 million for Amgen) after they were accused of using multiple foundations to induce Medicare patients to purchase the company’s drugs. As far as the details of th...
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    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...
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    Biosimilars Forum Calls for FDA Guidance to Address Misinformation

    Echoing a Pfizer petition and Novartis comments, the Biosimilars Forum said late last week that guidance from the US Food and Drug Administration (FDA) is needed to ensure reference product sponsors and other organizations communicate properly about biosimilars.   Amgen, which withdrew from the Forum recently, Roche’s Genentech and others have been singled out for misinformation campaigns that not only question the legal framework governing biosimilars but also the saf...
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    The Battle Over Neulasta Biosimilars in the US: What's Coming in 2018

    2016 and 2017 were difficult years for companies trying to win US Food and Drug Administration (FDA) approval for biosimilars of Amgen's blockbuster for treating side effects from chemotherapy. Last June, Coherus Biosciences received a complete response letter (CRL) for its biosimilar of Neulasta (pegfilgrastim), with FDA requesting "a reanalysis of a subset of subject samples with a revised immunogenicity assay, and requests for certain additional manufacturing re...
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    Amgen Challenge of FDA Decision on Pediatric Exclusivity Could Have Wider Implications

    Back in May, the US Food and Drug Administration (FDA) denied a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet), resulting in lawsuit filed by the drugmaker. A JAMA viewpoint published Wednesday argues that a decision in Amgen's favor could end up diminishing FDA's ability to encourage clinically meaningful pediatric studies. The case centers on the interpretation of how companies "fairly respond" to FDA's written requests ...
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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 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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    Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar

    The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar. But the win in court for Pfizer subsidiary Hospira does not mean that the biosimilar will launch in the US yet, as Pfizer reported on 22 June that it received a complete response letter (CRL) from the US Food and Drug Administration (FDA) for the application. The CRL relates to issues from an FDA warning lette...
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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...
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    FDA Science Board Weighs Plan for 'Cures' Funds

    The US Food and Drug Administration’s (FDA) science board met Tuesday to discuss an agency plan to spend $500 million over nine fiscal years on a variety of topics stipulated by the passage of the 21st Century Cures Act . Last week, FDA released its proposal for how it would spend the funds ahead of Tuesday’s meeting, with the bulk of the funds to be devoted to sections of the law on "Advancing New Drug Therapies" and "Patient Access to Therapies and Information."...
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    US Supreme Court to Consider Biosimilar Patent Process Next Week

    The highest court in the US next Wednesday will take up a fight over the so-called biosimilar "patent dance" and whether biosimilar companies have to notify reference product sponsors of the impending marketing of a new product, likely leading to a decision with ramifications for all subsequent biosimilars approved by the US Food and Drug Administration (FDA). The case, which will be decided by July, may set a precedent not only on whether the patent dance is neces...
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    Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

    The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars for Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab). Amgevita is authorized for all of the same indications as Humira, while Solymbic, which won approval through a duplicate marketing authorization application (MAA), is authorized for all indications except polyarticular juvenile idiopathic arthritis. Duplicate MAAs: Public Health or Co-Mar...