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  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 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...
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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...
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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 ...
  • 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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    Ulcerative Colitis Drugs: FDA Offers Draft Guidance on Clinical Development

    Pharmaceutical companies looking to understand FDA’s current thinking on efficacy endpoints for clinical trials to develop new ulcerative colitis (UC) treatments will be interested in new draft guidance released Friday. And though the guidance spells out what primary endpoints should be used, the agency also bemoans the fact that there are not well-defined and reliable clinician-reported, patient-reported and observer-reported outcome instruments for clinical trials. Ba...
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    Back to Back: FDA Panel Offers Unanimous Thumbs Up for Sandoz’s Enbrel Biosimilar

    For a second straight day, the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee unanimously pushed for the approval of a new biosimilar, this time for Sandoz’s biosimilar for Amgen’s blockbuster Enbrel (etanercept). Wednesday’s vote – 20-0, with no abstentions – comes on the heels of Tuesday’s 26-0 vote i n favor of approving Amgen’s biosimilar for AbbVie’s blockbuster Humira (adalimumab) . The discussion of Sandoz’s biosimilar was also less focuse...
  • Regulatory NewsRegulatory News

    FDA Panel Unanimously Backs Amgen’s Humira Biosimilar

    The US Food and Drug Administration’s (FDA) Arthritis Advisory Committee on Tuesday voted unanimously to support Amgen’s biosimilar for AbbVie’s blockbuster biologic Humira (adalimumab). The vote – 26-0, with no abstentions – followed the release of a positive review from FDA staff, and came after a lot of discussion on whether the data presented by Amgen could be extrapolated to all of the indications that Humira is approved for, as well as questions on analytical ch...
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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...