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.

Genentech Files Patent Infringement Complaint Against Lilly Regarding Lilly’s Taltz® Product

Last week, Genentech Inc. filed a complaint against Eli Lilly and Company (Lilly) in the United States District Court for the Southern District of California alleging infringement of U.S. Patent No. 10,011,654 (’654 patent) based on Eli Lilly’s commercial manufacture, use, sale, offer for sale and/or importation of Taltz® (ixekizumab) in…

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Biocon Biosimilars Facility Receives EU GMP Certification

Last week Biocon announced that it has received EU GMP certification for its biosimilars facility in Bangalore, after an inspection by European agencies this past March. Biocon’s Bangalore biosimilar facilities were also inspected earlier this year by the FDA, and last month Biocon announced the FDA issued an Establishment Inspection Report stating “that the inspection stands…

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FDA Releases Guidance for Industry Regarding Implementation of Biosimilar User Fee Amendments of 2017

The FDA recently announced the availability of a final guidance for industry titled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.”   This guidance concerns the implementation of BsUFA II, which as we previously reported, extends FDA’s authority to collect user fees from fiscal year (FY) 2018 to…

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Biosimilars Update: Clinical Trials, Marketing Authorization Applications, Licenses, and Launches

Today, we’re catching up with news from around the industry. Amgen recently announced top-line results from a Phase 3 study evaluating its infliximab biosimilar candidate, ABP 710.  According to the announcement, the study, a randomized, double-blind trial of 558 patients over 22 weeks, demonstrated the non-inferiority of ABP 710 to…

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Senators Ask FTC To Examine Biosimilar Patent Settlements For Antitrust Violations

United States Senators Chuck Grassley (R-Iowa) and Amy Klobuchar (D-Minn.) recently sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the “FTC to examine global patent settlements relating to biosimilars to ensure they are not in violation of antitrust laws.”  According to the Senators, “biologics constitute a…

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Judge Sets Trial Date in Janssen v. Celltrion Should Summary Judgment Be Denied

As we reported here, in the patent dispute between Janssen and Defendants Celltrion and Hospira relating to Inflectra® (infliximab-dyyb), a biosimilar of Remicade®, there are multiple motions for summary judgment pending before Judge Wolf in the District of Massachusetts. Both parties have filed competing summary judgment motions directed to damages issues. Additionally, Defendants have filed a motion…

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