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.

Genentech, Inc. and JHL Biotech, Inc. File a Stipulation for Entry of a Proposed Consent Judgment and Permanent Injunction; Court Order in Response Asks Parties to Answer Questions

On September 9, 2020, Genentech, Inc. and JHL Biotech, Inc. filed a stipulation for entry of a proposed consent judgment and permanent injunction as to JHL Biotech, Inc.  That proposed consent judgment and permanent injunction is the result of the parties’ June 18, 2020 settlement agreement, in which JHL represented…

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Low-Cost Syringe Technology May Enable Subcutaneous Injection of Viscous Formulations

In late August, MIT announced that a group of MIT researchers led by Kripa Varanasi published a paper describing a low-cost technology for administering biological drug formulations otherwise too viscous to be injected using conventional medical syringes.  The system utilizes a syringe having an inner barrel containing viscous drug fluid and an outer barrel…

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Samsung Bioepis Announces Phase 3 Exploratory Analyses Results of AYBINTIO (Bevacizumab)

Samsung Bioepis announced positive results yesterday from its exploratory analyses of the Phase 3 study of its biosimilar product, AYBINTIO (bevacizumab).  The study compared AYBINTIO’s efficacy to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).  According to Vice President and Team Lead of Medical…

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EMA Recommends Blenrep, Adakveo, and Equidacent for Approval

During the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) meeting this July, the CHMP recommended the approval of two biologics and one biosimilar: GlaxoSmithKline’s Blenrep (belantamab mafodotin), for treatment of relapsed and refractory multiple myeloma Novartis’ Adakveo (crizanlizumab), for prevention of vaso-occlusive crises in patients with sickle cell…

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AAM Renews Challenge to California’s Law Targeting Pharmaceutical Patent Infringement Settlements

On August 25, 2020, the Association for Accessible Medicines filed a new Complaint challenging California’s Assembly Bill 824 (“AB 824”).  Enacted in October 2019 and in effect as of January 1, 2020, AB 824 imposes a presumption of anticompetitive effect on certain agreements that involve generic or biosimilar manufacturers and…

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NeuClone Announces Active Development of Biosimilars Referencing OPDIVO and KEYTRUDA

On Sept. 1, 2020, NeuClone Pharmaceuticals announced that they are developing biosimilar candidates referencing OPDIVO and KEYTRUDA.  According to NeuClone, the two biosimilar candidates “are in the advanced states of pre-clinical development.”  This brings the number of NeuClone’s biosimilar pipeline to 8 announced products with another 12 in development that…

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