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    Home > Active Ingredient News > Immunology News > Adamo single anti-biosimilars! Yuflyma, the first high-concentration, low-volume, orange-free formula, has been approved by the European Union!

    Adamo single anti-biosimilars! Yuflyma, the first high-concentration, low-volume, orange-free formula, has been approved by the European Union!

    • Last Update: 2021-02-26
    • Source: Internet
    • Author: User
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    February 17, 2021 // -- South Korean biopharmaceutical giant Celltrion recently announced that the European Commission (EC) has approved Yuflyma (CT-P17, Adamo monobial-like drug), a biosimilar drug for AbbVie's overweight pound product Humira (Shumeile, common name: adalimumab, Adamo mono-resistant).
    approval, covering all 13 expected adaptations to treat a variety of chronic inflammatory diseases.
    it's worth noting that Yuflyma is the first adamu monobial-like drug with a high concentration, low volume, orange-free formula.
    IQVIA data, 60% of the Adamo monoantigen market in Europe is occupied by high concentrations of formulations.
    Youflyma is equipped with 29G needles and latex-free equipment with a shelf life of up to 24 months (2-8 degrees C).
    at room temperature, Yuflyma stabilizes for up to 30 days.
    Humira is AbbVie's super-heavy product, for several years in a row to sit on the global "drug king" throne.
    , Humira's global sales will be close to $20 billion ($19.832 billion) by 2020, according to earnings reports released earlier this month.
    in Europe, Humira lost patent protection on October 16, 2018 and several biosypolisic drugs are now on the market.
    U.S., Humira's market exclusive period ends in January 2023.
    , AbbVie had reached agreements with a number of pharmaceutical companies on the U.S. time-to-market for Adamo mono-biosygenic drugs, under which Amgen, Samsung Bioepis, Mylan, Sanders, Fessenyuscabi, Momenta, Coherus BioSciences developed Adamo mono-bio-similar Drugs are allowed to enter the U.S. market as early as January 31, June 30, July 31, September 30, September 30, November 20, November 20, and December 15, 2023.
    EC approved Yuflyma to comply with the Marketing Authorization Recommendations issued by the European Medicines Agency (EMA) Committee on Human Pharmaceutical Products (CHMP) in December 2020.
    this approval, based on analytical, preclinical, and clinical studies, confirms that Yufflyma is comparable in terms of safety, efficacy, PK/PD, immunogenicity with reference drug Humira (Adamo monoanti) treatment 24 and treatment 1 year.
    Based on the results of key studies, the high-concentration formula Yuflyma has been approved in the European Union (EU) for the treatment of 13 chronic inflammatory diseases; rheumatoid arthritis (RA), juvenile idiothiotic arthritis (JIA), strong straight spina bifidositis (AS), as-axial arthritis without AS imaging evidence (nr-axSpA), Psoriasis arthritis (PsA), psoriasis (PsO), plaque psoriasis (pPsO), purulent sweat adenitis (HS), Crohn's disease (CD), children's Crohn's disease (pCD), ulcerative colitis (UC), vineitis (UV) and children's staphylococcitis (pUV).
    "In Europe, according to IQVIA data, high-concentration agents account for 60 percent of the total Adamo monoanti-resistant market, while high-concentration agents have replaced more than 90 percent of the original Adamo mono-resistance market," said Dr. HoUng Kim, head of medical and marketing at celltrion Healthcare.
    high concentration, low-volume adamo resistance causes less pain, at least to improve treatment compliance.
    , we are focused on developing high-concentration biosimilars to provide important alternatives to the Adamo monotherapy category.
    In terms of dosing equipment, we want to ensure better convenience for patients and healthcare providers, including needle sizes (29G), latex-free to reduce allergy risk, and long storage or shelf life of up to 30 days at room temperature.
    Professor Rieke Alten, Director of Internal Medicine, Rheumatology, Clinical Immunology and Orthopaedics, Charite Teaching Hospital, Berlin, Germany, said: "Over the past 20 years, anti-tumor necrosis factors (TNF) biologics have revolutionized the treatment of chronic immuno-mediated inflammatory diseases, but some characteristics need to be improved to enable patients to achieve treatment objectives.
    as a physician, we welcome these value-added features, such as high concentration and low volume formulations, to reduce injection discomfort.
    " () Origin: Celltrion Healthcare Receives European Commission (EC) approval for first high mass, low-volume and citrate-free biosimilar adalimumab, YuflymaTM (CT-P17)
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