Tagged as: CHMP

Ranibizumab Biosimilar Program Updates

This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular (wet) age-related macular degeneration (AMD). On June 25, 2021, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) and Biogen Inc. (“Biogen”) announced that the…

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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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EMA Recommends Blenrep, Adakveo, and Equidacent for Approval

During the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) meeting this July, the CHMP recommended the approval of two biologics and one biosimilar: GlaxoSmithKline’s Blenrep (belantamab mafodotin), for treatment of relapsed and refractory multiple myeloma Novartis’ Adakveo (crizanlizumab), for prevention of vaso-occlusive crises in patients with sickle cell…

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Lupin, Mylan Launch Etanercept Biosimilar in Germany

Yesterday, Lupin announced the German launch of its etanercept biosimilar, Nepexto, for the treatment of rheumatoid arthritis, as well as all other approved indications of the reference product Enbrel®. Lupin, in association with Mylan will release its etanercept product as an injectable in an easy-to-use pre-filled pen and a pre-filled…

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Centus Biotherapeutics Receives Positive Opinion for EQUIDACENT (Bevacizumab Biosimilar) in Europe

On July 23, 2020, Centus Biotherapeutics received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for EQUIDACENT, a biosimilar to AVASTIN (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer,…

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Henlius and Accord Announce EMA Recommendation for Marketing of Their Trastuzumab Biosimilar

We previously reported on Shanghai Henlius’s (“Henlius”) biosimilar developments, including their announcement of an exclusive license agreement with Mabxience Research, S.L. to develop and commercialize their trastuzumab biosimilar, HLX02. This week, Henlius jointly announced with Accord Healthcare Limited that the Committee for Medicinal Products for Human Use (CHMP) of the…

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Rituximab Biosimilar Updates from Europe

Mabion We previously reported last month that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP).  In particular, the EMA reported that these applications were withdrawn after the agency had evaluated…

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Meeting Highlights from the Committee for Medicinal Products for Human Use

The European Medical Agency’s Committee for Medicinal Products for Human Use (CHMP) recently reported biosimilar updates from its March 2020 meeting.  At the meeting, Mylan and Lupin’s NEPEXTO (etanercept) received a positive opinion for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing…

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