Tagged as: Celltrion

Celltrion’s Trastuzumab Biosimilar Earns WHO Prequalification Status

Celltrion recently announced that its trastuzumab biosimilar, Herzuma, has met the World Health Organization’s (WHO) prequalification standards.  WHO prequalification status is based on an assessment of the quality, safety, and efficacy of a medicine and enables the recipient to participate in UN procurement tenders.  Herzuma has been commercially available in Europe since May 2018,…

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BREAKING NEWS: Celltrion Prevails Over Janssen in Infliximab Biosimilar Appeal

Today, the Federal Circuit issued a Rule 36 affirmance of the district court’s judgment of non-infringement in the litigation involving Celltrion’s infliximab biosimilar.  The court heard oral argument in the appeal yesterday.  As we previously reported, Janssen had appealed the district court’s order granting Celltrion’s motion for summary judgment of non-infringement of…

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Biosimilar Development Update: Mochida, Celltrion, Innovent, DRL, Fresenius

Below are some highlights of recent biosimilar development news from this week:   On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. …

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Genentech Settles Rituximab Patent Dispute with Celltrion and Teva

On November 1, 2018, Genentech and its co-plaintiffs dismissed the lawsuits they brought against Celltrion and Teva under the BPCIA in the District of New Jersey, in which the plaintiffs alleged that Celltrion’s filing of an aBLA relating to Truxima®, Celltrion’s proposed biosimilar to Rituxan® (rituximab), infringed certain patents.  The…

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ODAC Votes in Favor of Biosimilarity of Celltrion's CT-P10

As reported here, the Oncologic Drug Advisory Committee (ODAC) held a public hearing today at the U.S. Food & Drug Administration to discuss and vote on Celltrion’s Biologics License Application for CT-P10, a proposed biosimilar of Genentech’s U.S.-licensed rituximab product Rituxan.   The hearing included presentations from various speakers from industry,…

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Biosimilar and Biologic Development Updates

On Wednesday, Celltrion announced its completion of its Phase 3 clinical trial for Remsima SC, a subcutaneous version of its biosimilar Remsima® (infliximab).  According to Celltrion, “[t]he subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to…

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