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.

Clinical Trial Announcements

This week, several companies reported updates in their clinical development of biosimilars or follow-on biologics. On December 3, Outlook Therapeutics (formerly known as Oncobiologics) announced the FDA agreed with three of Outlook’s proposed Special Protocol Assessments (“SPAs”) relating to ONS-5010, an investigational ophthalmic formulation of bevacizumab which is currently in…

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U.S. Biosimilar Launches: Mylan/Biocon’s Trastuzumab, Sandoz’s Pegfilgrastim

Yesterday, Mylan N.V. and Biocon Ltd. announced the U.S. launch of OGIVRI (trastuzumab-dkst), a biosimilar to HERCEPTIN (trastuzumab).  According to the press release, “OGIVRI™ is approved for all indications of HERCEPTIN® including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma),” and is available in both…

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Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own…

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China NMPA Approves Adalimumab Biosimilar

On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar approved by the NMPA and has been approved for the treatment of three autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and plaque…

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