Welcome to the Big Molecule Watch!


Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

Minnesota Bill Aimed at Expanding Access to Biosimilars

Last Wednesday, State Senator Carla Nelson and State Representative Jennifer Schulz of Minnesota announced the introduction of a bill aimed at reducing the price of certain medications by expanding access to biosimilars.  The bill requires that pharmacy benefit managers and health carriers must not require or demonstrate a preference to…

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Meta-analysis Finds Nonsignificant Differences Between Infliximab Biosimilars

On February 18, 2021, the American Journal of Health-System Pharmacy published the results of a meta-analysis evaluating the use of infliximab in patients with rheumatoid arthritis (RA). The meta-analysis evaluated patient response rates to treatment with the infliximab reference product REMICADE compared to treatment with infliximab biosimilars. The study’s authors…

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Samsung Bioepis Initiates Phase 1 Trial of Ustekinumab Biosimilar

Earlier today, Samsung Bioepis announced the initiation of a Phase 1 clinical trial for SB17, the company’s proposed biosimilar to Stelara® (ustekinumab).  The trial will compare the pharmacokinetics, safety, tolerability, and immunogenicity of SB17 and Stelara®.  With the start of this trial, Samsung Bioepis has the following biosimilar candidates in…

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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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Recent Adalimumab Biosimilar Updates

On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021.  Yuflyma™ was approved across all thirteen intended indications covered by the reference biologic, Humira®.  Yuflyma™ is a high concentration, low-volume and citrate-free adalimumab biosimilar, which, according…

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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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