The FDA today approved Sandoz’s application for a biosimilar version of Amgen’s Enbrel product (etanercept). Sandoz’s biosimilar is called Erelzi. It is the first biosimilar etanercept approved by FDA, and the third product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars (first was Sandoz’s Zarxio (filgrastim)…
As we posted previously, the District Court in Janssen v. Celltrion has ruled that the ‘471 patent is invalid for obviousness-type double patenting on the two grounds raised in the defendants’ motions for summary judgment on that patent. The defendants last week moved for an entry of final judgment on the plaintiffs’ infringement allegations for the…
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…