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.

Biologic and Biosimilar Approval Updates

The U.S. FDA recently approved Genentech’s Phesgo™ for the treatment of early and metastatic HER2-positive breast cancer, in combination with chemotherapy.  Phesgo™ is a fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase, administered via subcutaneous injection. Fujifilm Kyowa Kirin Biologics recently announced that it received approval in Japan for its adalimumab…

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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 notice provides…

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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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