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.

Federal Circuit Affirms PTAB Finding that Rituxan® Biogen Patent is Invalid

As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies and covering the cancer therapeutic RITUXAN (rituximab), were unpatentable on obviousness grounds. After appealing to…

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Boehringer Ingelheim Files Citizen Petition Urging FDA to Address “Strength” Definition for Biosimilars, Citing Concerns Over Evergreening

On December 2, 2020, Boehringer Ingelheim Pharmaceuticals, Inc. submitted a Citizen Petition to the FDA, requesting that it interpret the term “strength” in section 351(k) of the Public Health Service Act for parenteral solutions to mean “total drug content,” without regard to concentration.  Boehringer Ingelheim maintains that this correction would…

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Adalimumab Biosimilar Update: Shanghai Henlius Biotech’s Approval in China and Celltrion’s Positive Opinion in the EU

Last week, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved its adalimumab biosimilar candidate for the treatment of rheumatoid arthritis, ankylosing spondylitis, and plaque psoriasis.  Henlius stated that this is its third biosimilar approval in China, following approval of its rituximab and trastuzumab biosimilar products. Celltrion…

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ASH Presentations Show Benefits of Biosimilar Pegfilgrastim Over On-Body Injector

Investigators presented two studies on Monday at the American Society of Hematology Annual Meeting and Exposition (ASH) showing the potential for significant cost-savings by switching to biosimilar pegfilgrastim from the pegfilgrastim on-body injector (PEG-OBI). In one study, investigators demonstrated a potential for savings from a conversion to several biosimilar filgrastim…

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Biosimilar Market Updates: Samsung Biologics, Celltrion, and Alvotech

Samsung Biologics’ third quarter report disclosed that it had suspended its research and development of its SAIT101, a biosimilar of Rituxan.  As we previously reported, the rituximab product was being developed through Archigen Biotech, a joint venture with AstraZeneca.  According to a report in Korea Biomedical Review, a Samsung Biologics…

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