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.

Trastuzumab IPR Updates

Last month, the PTAB issued decisions on two petitions, IPR2017-02063 and IPR2018-00016, filed by Pfizer against one of Genentech’s Herceptin® (trastuzumab) patents, U.S. Patent No. 7,846,441 (“the ‘441 patent”). The ‘441 patent has claims directed to methods of treating a malignant progressing tumor or cancer characterized by overexpression of ERBB2 receptor. IPR2017-02063…

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Update on biosimilar launches and development

Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea.  Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…

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South Dakota Passes Automatic Substitution Law for Interchangeable Biosimilars

South Dakota passed a law that allows pharmacists to automatically substitute a biosimilar for a prescribed biological product.  According to the new law, which was signed by South Dakota’s governor on February 12, 2018, the biosimilar must be “interchangeable” with the prescribed biological product under 42 U.S.C. § 262(k)(4) to qualify…

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Biosimilar Litigation Updates: Joint Status Reports

Genentech v. Pfizer (trastuzumab): On February 12, 2018, the parties filed a joint status report.  Among other things, the parties offered their competing proposals for discovery deadlines.  The parties stated that they have been “engaged in the exchanges of information provided under the” BPCIA and that Pfizer provided its notice of…

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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

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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