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.

Janssen v. Celltrion: Scheduling Order Entered

The United States District Court for the District of Massachusetts entered a scheduling order in the ongoing Janssen v. Celltrion litigation concerning Celltrion’s Inflectra®, a biosimilar of Janssen’s Remicade® (infliximab), for the remainder of discovery, pre-trial activities, and trial.  The parties are ordered to reserve June 11, 2018 through June 29,…

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American College of Rheumatology White Paper Encourages Use of Biosimilars

Last week, the American College of Rheumatology (ACR) published a new white paper “encourag[ing] providers to incorporate [biosimilars] into the treatment plans of patients with rheumatic diseases where appropriate.” The paper, titled “The Science Behind Biosimilars — Entering a New Era of Biologic Therapy,” discusses the regulatory regime for biosimilars,…

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PTAB Denies Institution Of IPR On Two Humira Patents

The PTAB has denied institution of inter partes review of two Abbvie patents that relate to HUMIRA (adalimumab). On February 9, 2018, the PTAB denied Sandoz’s IPR2017-01824 on U.S. Patent No. 9,512,216, which is directed to a method of treating plaque psoriasis by subcutaneously administering a claimed regimen of adalimumab. On the same day, the PTAB…

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Goodwin’s Willy Jay Speaks at Access! 2018 - AAM Annual Meeting

Goodwin’s Willy Jay is speaking on a panel this week at the Annual Meeting of the Association for Accessible Medicines, formerly known as the Generic Pharmaceutical Association, Access 2018. Mr. Jay’s panel focuses on issues relating to closing the legal loopholes blocking access to generics and biosimilars. AAM states that…

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Lupin Announces Positive Results For Etanercept Biosimilar

On February 7, 2018, Lupin announced positive results from a Phase III clinical trial for its etanercept biosimilar candidate, YB113.  YB113 is being developed by YL Biologics, a joint venture of Lupin and Yoshido, a Japanese pharmaceutical company.  The clinical trial compared the safety and efficacy of YB113 to Amgen’s…

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Countries Enter into CPTPP without U.S.

About one year after the US withdrew from the Trans-Pacific Partnership, the Comprehensive Progressive Agreement Trans-Pacific Partnership (CPTPP) is to be signed in March by the remaining countries (with ratification expected in 2019). The remaining eleven countries include: Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and…

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Trastuzumab Biosimilar Demonstrates Equivalence

The Journal of Clinical Oncology reported that Merck and Samsung Bioepis’ biosimilar to trastuzumab (Herceptin®), SB3, demonstrated equivalence to trastuzumab in recent Phase III trials. According to the report, in a phase III, randomized, double-blind study of 800 women with HER2-positive breast cancer, SB3 induced a rate of breast pathologic complete…

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GABI Publishes Data on Italian Biosimilar Landscape

A paper published in the Generics and Biosimilars Initiative Journal reports on “an overview of the available real-world data about the pattern of use and the comparative effectiveness of biosimilars and originator biological drugs in Italy.” The paper, which was based on studies funded by the Italian Ministry of Health,…

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Federal Circuit Affirms Dismissal of AbbVie's Humira License Suit

The Federal Circuit has ruled that AbbVie’s declaratory judgment action seeking to invalidate a patent licensed from MedImmune will not go forward. AbbVie licensed several patents stemming from a research collaboration that produced adalimumab, the active ingredient in Humira. The license provides for royalties until the later of expiry of the…

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