Tagged as: EMA

EMA Recommends Blenrep, Adakveo, and Equidacent for Approval; Recommends Change in Prescription Status for Crysvita and Imfinzi

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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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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Xbrane Biopharma Plans to Continue Phase III Trial of its Xlucane® (Ranibizumab) Biosimilar Product

Swedish biotechnology company Xbrane Biopharma reports that, despite the difficulties posed by the Covid-19 pandemic, it will continue to recruit patients for the ongoing Phase III trial of its Xlucane® (ranibizumab) biosimilar product, and that it is still on track towards regulatory approval ahead of Lucentis® patent expiration in 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previously reported last month that applications for initial marketing authorization for two rituximab biosimilars were withdrawn from the European Medicines Agency (EMA), according to the Committee for Medicinal Products for Human Use (CHMP).  In particular, the EMA reported that these applications were withdrawn after the agency had evaluated…

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European Commission Approves Pegfilgrastim Biosimilars

The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech.  According to Mundipharma, the product is approved for the “use of Pelmeg▼® as a treatment for…

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Biosimilars Update: Clinical Trials, Marketing Authorization Applications, Licenses, and Launches

Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710.  According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…

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Mylan Partners with Fujifilm Kyowa Kirin Biologics

Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we previously reported, the European Medicines Agency (EMA) accepted FKB’s Marketing Authorization Application for review on May 18, 2017 and the companies expect to get a decision from EMA by the second half of this year. Under the agreement, FKB grants Mylan…

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