Tagged as: EMA

EMA Reports on Pilot Program on Tailored Scientific Advice for Biosimilar Development

On September 30, 2021, the European Medicines Agency (EMA) released a report entitled “Tailored Scientific Advice for Biosimilar Development,” describing results from its pilot program in which biosimilar applicants were invited to solicit scientific advice from regulatory authorities. In the European Economic Area (EEA), biosimilar approval requires applicants to submit…

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Celltrion Seeks EMA Approval for Avastin Biosimilar

The Korea Herald has reported that Celltrion Inc., a South Korean biopharmaceutical firm, is seeking approval from the European Medicines Agency (EMA) for the sale of CT-P16, Celltrion’s anticancer biosimilar candidate.  CT-P16 references Avastin (Bevacizumab), which is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney…

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CHMP adopts positive opinion on Alvotech’s adalimumab biosimilar

European Medicines Agency

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab).  Humira® is approved to treat certain inflammatory conditions.  Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s…

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CHMP adopts positive opinions on two bevacizumab biosimilars

At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas.  Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small…

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Adalimumab Biosimilar Update: Shanghai Henlius Biotech’s Approval in China and Celltrion’s Positive Opinion in the EU

Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.  Henlius stated that this is its third biosimilar approval in China, following approval of its rituximab and trastuzumab biosimilar products. Celltrion…

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FDA Accepts Application From Samsung Bioepis and Biogen For Lucentis® (ranibizumab) Biosimilar

Samsung Bioepis and Biogen issued a press release on November 18 announcing that the U.S. Food and Drug Administration has accepted for review their Biologics License Application for SB11, a proposed biosimilar of Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy used to treat retinal vascular disorders,…

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