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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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FDA Announces Biosimilar Funding Opportunity

On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals.  Specifically, the FDA anticipates awarding as many as five proposals up to $1 million in funding.  This FOA arises…

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China Accepts Innovent Biologics’ Supplemental New Drug Application for Sintilimab Plus Bevacizumab Biosimilar Injection

On December 24th, 2021, Innovent Biologics announced that China’s National Medical Products Administration had accepted its Supplemental New Drug Application (sNDA) for TYVYT®, a sintilimab plus bevacizumab biosimilar injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer (nsqNSCLC) who progressed after EGFR-TKI therapy. The sNDA is based on…

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Alvotech’s E.D. Va. Declaratory Judgment Action Against AbbVie Transferred to N.D. Ill.

On Friday, October 22, 2021, Judge Raymond A. Jackson of the Eastern District of Virginia (E.D. Va.) transferred Alvotech USA and Alvotech hf.’s (jointly, “Alvotech”) declaratory judgment suit against AbbVie Inc. and AbbVie Biotechnology Ltd. (jointly, “AbbVie”) to the Northern District of Illinois (N.D. Ill.) and dismissed AbbVie’s pending motion…

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Recent Launches – Formycon, Bioeq and Boryung, Samsung Bioepis

On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus…

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