Welcome to the Big Molecule Watch!

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Goodwin’s award-winning Big Molecule Watch is the best resource for daily updates and analyses of regulatory issues, litigation, legislation, and other news in the world of biologics, biosimilars and related technologies. The editors of this blog have collectively been watching and engaging with the world of biologics and biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S.  With extensive experience representing clients at all stages of a biologic’s or biosimilar’s lifecycle, from research and development, to patents, to regulatory application and approval, and through litigation and appeals, we are excited to share our observations and insights as the industry and the law continues to develop in this exciting area.

This blog focuses on “big molecules” as opposed to “small molecules.” Small molecule drugs have low molecular weight, a simple and well-defined structure, and are chemically synthesized. In contrast, “big molecule” drugs have high molecular weight, complex structures, and are derived from living organisms. For example, aspirin is small molecule while a monoclonal antibody is a big molecule. For further reading on big molecules, consider FDA's resources on biologics.

Association of Accessible Medicines: Ensuring the Future of Accessible Medicines in the U.S.

The Association of Accessible Medicines (“AAM”) released a white paper on avoiding shortages and ensuring drug competition for patients in America.  AAM is advocating for the uninterrupted availability of lower-cost generic and biosimilar medicines.  In the paper, AAM asserts that by placing biosimilar medicines on a level competitive playing field with…

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Study Shows that Celltrion’s Infliximab Biosimilar is Comparable to Reference Infliximab and Adalimumab

gloved hand withdraws drug solution with syringe

According to a Celltrion press release, this week investigators presented twelve-month data from a UK-wide, three-year prospective observational study showing comparable efficacy between CT-P13 (Celltrion’s biosimilar infliximab), reference infliximab (Johnson and Johnson’s Remicade), and adalimumab (AbbVie’s Humira). The press release reports that the Personalised Anti-TNF therapy in Crohn’s disease Study…

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Express Scripts and Walgreens Expand Their Group Purchasing to Include Biosimilars

Express Scripts and Walgreens Boots Alliance announced this week that “they are expanding their group purchasing efforts to include the procurement of specialty brand drugs,” including biosimilars.  According to Tim Wentworth, Express Scripts President and CEO, “[s]pecialty medications represent the most costly and complex drugs.  By expanding our efforts with Walgreens Boots Alliance, we…

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Sanofi Opposes Amgen’s Petition for Rehearing En Banc in Praluent® Litigation

As we previously reported, Amgen is seeking en banc review of the Federal Circuit panel decision vacating a permanent injunction that would have otherwise prohibited the sale of Sanofi and Regeneron’s Praluent® (alirocumab) product and remanding the appeal to the district court for a new trial on the defendants’ written…

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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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