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Merck Completes Organon Spinoff

As we previously reported, earlier this year Merck announced that it would be spinning off its women’s health, biosimilars, and established brands businesses into a standalone company.   This month, Merck completed the spinoff, creating Organon.  Organon’s portfolio contains about 60 treatments and products, and mainly focuses on ex-US markets.  Organon…

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Global Biosimilar Update

The European Commission has approved mAbxience’s bevacizumab biosimilar, MB02, for marketing in Europe.  As we previously reported, MB02, which will be known as Alymsys and Oyavas, is intended for the treatment of colon or rectal carcinoma, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian cancer, fallopian tube…

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Now Available! Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., 2020-2021 Edition

As regular Big Molecule Watch readers know, the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law as part of the Affordable Care Act on March 23, 2010, creating an abbreviated licensure pathway for “biosimilar” and “interchangeable” biological products.  The BPCIA also introduced a new scheme to resolve…

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Celltrion begins Phase 3 trial of aflibercept biosimilar

Celltrion Inc. has begun a Phase 3 clinical trial of CT-P42, an aflibercept biosimilar referencing Regeneron’s Eylea.  The trial will enroll 300 patients with diabetic macular edema, and aims to compare CT-P42’s efficacy, safety, pharmacokinetics, and immunogenicity against Eylea. Celltrion adds CT-P42 to its pipeline of other investigational biosimilars, including…

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Clinical Updates

As described below, Adocia, Cue Biopharma, and Eucure Biopharma each recently announced clinical updates with regards to their biologic product candidates or combination therapies. Adocia, a clinical-stage biotechnology company headquartered in France, reported positive results from a clinical pharmacology study using its proprietary BioChaperone® (BC) ultra-rapid prandial insulin formulation.  The study…

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