Welcome to the Big Molecule Watch!

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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.

First Patient Dosed with Stelara® biosimilar in Bio-Thera Solutions’ Phase III Clinical Trial for Moderate to Severe Psoriasis

Last week, Bio-Thera Solutions announced that a first patient has been dosed in its Phase III clinical trial study for ustekinumab biosimilar BAT2206. Stelara® (ustekinumab) is marketed by Johnson & Johnson Corp. for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe active Crohn’s disease…

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The FDA’s Purple Book

As we previously reported, the “Consolidated Appropriations Act” enacted in December of last year contained a provision that required FDA to create a searchable, electronic database of biologics and to update it with patent information provided to an applicant during the patent dance.  As of the effective date of June…

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President Biden Issues Executive Order Including Provisions To Promote Generic Drug and Biosimilar Competition in the American Economy

On July 9, President Biden issued an Executive Order regarding competition in various sectors of the United States economy, including the healthcare market.  Among the 72 initiatives set forth in the Order are instructions that charge various agencies with tasks to promote generic and biosimilar competition.  The Order directs the Food…

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Innovent Announces the Approval of a First-Line Therapy for People with Hepatocellular Carcinoma in China

Innovent Biologics, Inc. announced that the National Medical Products Administration of China (“NMPA”) approved its supplemental New Drug Application for TYVYT®, a sintilimab injection, in combination with BYVASDA®, a bevacizumab biosimilar injection, as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma (“HCC”).  According to the press release,…

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Alvotech Announces Reaching the Primary Completion Date in Its AVT02 Switching Study

On June 15, 2021 Alvotech announced that data collection has been completed from the last of its 568 clinical trial study participants in AVT02-GL-302, a switching study for AVT02, the company’s biosimilar to high concentration (100mg/mL) Humira®. The switching study compared the pharmacokinetics, efficacy, safety, and immunogenicity of AVT02 (40…

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Ranibizumab Biosimilar Program Updates

This week, three development programs announced updates to their ranibizumab biosimilars. Ranibizumab is the active ingredient in Genentech’s LUCENTIS, which is indicated for retinal vascular disorders, including neovascular (wet) age-related macular degeneration (AMD). On June 25, 2021, Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) and Biogen Inc. (“Biogen”) announced that the…

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