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.
Yesterday, Celltrion filed a petition
for inter partes review of Genentech’s U.S. Patent No. 7,976,838, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on […]
We have previously reported
on the complicated naming issues surrounding biosimilar products and how biological qualifiers, such as three or four-letter codes, should be added to distinguish between them. However, the naming of the […]
In a stipulation
filed yesterday in Janssen v. Celltrion
, Celltrion has agreed not to sell its Remicade biosimilar in the U.S. for use by doctors or patients before October 3, 2016, and the parties have agreed to dismiss all claims and […]
As we reported last week
, the district court granted Celltrion’s Motion for Summary Judgment of Invalidity for one of the two patents-at-issue in Janssen v. Celltrion
. The Korea Times reports
that Celltrion shipped its first […]
Following three days of hearings in Janssen v. Celltrion
, the District Court for the District of Massachusetts (J. Wolf) today issued a memorandum order
summarizing the Court’s rulings on several pending motions in the […]
Below is a brief summary of each of the U.S. patent litigations concerning a proposed or approved biosimilar product. Please also consult our BPCIA Litigation Summary Chart
for additional details. Biosimilars to Neupogen® (filgrastim)
On August 16, bioeq filed a petition
for inter partes
review of U.S. Patent No. 6,716,602, titled “Metabolic rate shifts in fermentations expressing recombinant proteins.” The patent is owned by Genentech and is directed to […]
As we previously reported
, the district court in Janssen v. Celltrion
(in which U.S. Patent Nos. 6,284,471 and 7,598,083 are at issue) began hearing oral argument on August 16 on Celltrion’s motion for summary […]
The August, 2016, edition of the Journal of Managed Care & Specialty Pharmacy
published the results of a survey designed to measure pharmacists’ view on biosimilar naming conventions. (See our previous posts here
According to a press release
, Novartis AG has contracted Jacobs Engineering Group Inc. to provide engineering, procurement, and construction management services to expand monoclonal antibody (mAb) production capacity by 70% and to establish […]