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.

ALJ Recommends Exclusion in Botox Trade Secret Case

    We previously reported on an International Trade Commission hearing in a trade secret dispute brought by Allergan and Medytox against Daewoong and Evolus.  In the underlying investigation, Allergan and Medytox seek to block importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  A one-page public…

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BREAKING NEWS: Genentech and Amgen Settle HERCEPTIN and AVASTIN Biosimilar Disputes

Today, Genentech and Amgen jointly filed stipulations in the U.S. District Court for the District of Delaware dismissing their BPCIA litigations concerning Amgen’s biosimilars of Genentech’s HERCEPTIN (trastuzumab) and AVASTIN (bevacizumab) oncology products. According to each court submission, the parties entered into a settlement agreement and mutually agreed to voluntarily…

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FDA Approves Mylan’s Biosimilar of HUMIRA (Adalimumab)

On July 6, 2020, the U.S. FDA approved Mylan’s aBLA for HULIO (adalimumab-fkjp), a biosimilar of AbbVie’s HUMIRA. HULIO is indicated for treating certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis, and plaque psoriasis. HUMIRA, in contrast, is additionally approved for…

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BREAKING NEWS: Federal Circuit Denies Genentech’s Appeal to Block Sales of Amgen’s MVASI (bevacizumab-awwb)

Today, in the Genentech v. Amgen BPCIA litigation concerning Amgen’s MVASI (bevacizumab-awwb) biosimilar product, the U.S. Court of Appeals for the Federal Circuit issued an opinion affirming the district court’s denial of Genentech’s motions to enjoin sales of MVASI in the United States.  MVASI is an FDA-approved biosimilar of Genentech’s…

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Cost savings with biosimilar pegfilgrastim-cbqv in prophylaxis of chemo-induced febrile neutropenia

Researchers from the University of Arizona Cancer Center recently presented results of a simulation designed to model the cost savings from converting patients from pegfilgrastim to biosimilar pegfilgrastim-cbqv.  The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting on May 29-31, 2020. The researchers conducted simulation…

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Denosumab biosimilar IND approval in China and teriparatide biosimilar launch in South Korea

Shanghai Henlius Biotech (Henlius) recently announced that China’s National Medical Products Administration (NMPA) has approved an investigation new drug (IND) application[1] of HLX14, a denosumab biosimilar.  Denosumab is a recombinant humanized anti-RANKL monoclonal antibody for injection that is approved for the treatment of postmenopausal women with osteoporosis with a high…

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Bevacizumab Updates

On June 16, 2020, Shanghai Henlius Biotech, Inc. announced that HLX04-mCRC03, a phase 3 clinical trial of bevacizumab biosimilar HLX04, had successfully met its primary endpoint.  The study compared the safety, efficacy and immunogenicity of HLX04 and Avastin in combination with oxaliplatin and fluoropyrimidine-based chemotherapy as first-line treatment in patients…

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