Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) announced that Brenzys, an etanercept biosimilar, “could be marked as equivalent” to the branded antibody Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS). Considering the clinical evidence presented, PBAC recommended that there was “comparative safety and effectiveness of Brenzys and Enbrel.” Therefore, by substituting…
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 updates for IPR2016-01667 and will post key documents on our IPR tracker page.
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 original biologic drug product is well established, as outlined by the World Health Organization (WHO), and…
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 defenses related to Defendants’ alleged violation of the BPCIA’s 180-day notice of commercial marketing provision (42…
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 batch of its Remicade biosimilar, Remsima, to the U.S. on August 19th, the day after the ruling. Please continue to…
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 case. The Court granted Defendants’ Motion for Summary Judgment of Invalidity of the ’471 patent on both…
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.
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 a method for increasing product yield of a polypeptide produced by recombinant host cells. We will…
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 judgment that all claims of the ’471 patent-in-suit are invalid for obviousness-type double patenting, as well…
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 and here for more information regarding the naming of biosimilars.) The survey found that pharmacists would generally prefer…