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Celltrion and Rani Therapeutics to Jointly Develop Oral Formulation of Adalimumab Biosimilar

Celltrion and US-based Rani Therapeutics (“Rani”) announced that they entered an agreement to develop RT-105, an orally administered adalimumab biosimilar made using the RANIPILL platform.  The announcement explains that RANIPILL capsules are Rani’s payload agnostic oral delivery technology intended to replace subcutaneous or intravenous injection of biologics or drugs, and…

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Year in Review: Top Biosimilars-Related Regulatory Developments of 2022

As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several…

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Celltrion USA Announces Submission of BLA for Subcutaneous Infliximab Biosimilar 

On December 22, 2022, Celltrion USA announced that it submitted a Biologics License Application (BLA) for a subcutaneous formulation of infliximab, CT-P13, to the U.S. Food and Drug Administration (FDA).  According to Celltrion, the BLA is based on phase III pivotal data that evaluated the efficacy and safety of CT-P13 as a…

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BPCIA Aflibercept Litigation:  Regeneron Files 12(c) Motion to Dismiss Mylan’s Counterclaim for Inequitable Conduct

On Friday, December 16, 2022, Regeneron moved to dismiss Mylan’s inequitable conduct defense and counterclaim against two of the six patents asserted in the parties’ BPCIA suit concerning Mylan’s proposed biosimilar to EYLEA.  As previously reported, Regeneron narrowed the twenty-four patents originally asserted against Mylan to six following the Northern…

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The UK’s MHRA Updates its Guidance on Licensing of Biosimilars

On November 7, 2022, the UK’s Medicines and Healthcare Products Regulatory Agency (“MHRA”) updated its “Guidance on the licensing of biosimilar products” by expanding the criteria for achieving interchangeability between a biosimilar and reference medicinal product (“RP”).  The UK’s Guidance now recognizes that “[o]nce authorised, a biosimilar product is considered…

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FDA Accepts Outlook Therapeutics' BLA for Ophthalmic Bevacizumab

Bottle of Pills and a FDA APPROVED rubber stamp

Outlook Therapeutics recently announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for ONS-5010 / LYTENAVA (bevacizumab-vikg), an investigational ophthalmic formulation of bevacizumab for the treatment of wet age-related macular degeneration (wet AMD).  There are no FDA-approved ophthalmic formulations of bevacizumab currently…

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Lupin Announces Approval of ENBREL Biosimilar in Canada

On September 13, 2022, Lupin Ltd. (“Lupin”) announced that its RYMTI product, a biosimilar to ENBREL (etanercept), has been approved in Canada.  Lupin, based in Mumbai, India, specializes in cardiovascular, diabetic, and respiratory disease treatments.  RYMTI is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial…

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Celltrion Files IND with FDA for Adalimumab Biosimilar

As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its biosimilar’s (YUFLYMA) interchangeability with HUMIRA (adalimumab).  The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis….

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EMA CHMP Recommends Three Biosimilars - Big Molecule Watch

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products.  On June 23, 2022, CHMP recommended the grant of a marketing authorization for RANIVISIO (ranibizumab) to Midas Pharma GmbH.  RANIVISIO references LUCENTIS® and, if approved, would be used to…

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JSR Life Sciences Launches New “Similis Bio” Business Division to Accelerate Biosimilar Development

JSR Life Sciences recently announced its launch of a new business division, “Similis Bio,” intended to help biosimilar drug developers “improve the efficiency and cost of biosimilar development.”  Specifically, Similis Bio will offer analytical and process development data that developers can use to “determine an appropriate biosimilar target, accelerate early…

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