To view our full FDA Approvals tracking table, click here. Adalimumab+ HUMIRA #1 Biosimilar: AMJEVITA (adalimumab-atto) Applicant: Amgen BLA Approval: Sept. 23, 2016 US Launch: January…
To view our full FDA Approvals tracking table, click here. Adalimumab+ HUMIRA #1 Biosimilar: AMJEVITA (adalimumab-atto) Applicant: Amgen BLA Approval: Sept. 23, 2016 US Launch: January…
The Korea Herald reports that Celltrion is on track to file applications for U.S. FDA approval for its rituximab and trastuzumab biosimilars by June. According to the article (and as…
On April 27, 2017, The Korea Herald and The Investor reported that Celltrion and Nippon Kayaku entered into an agreement under which Nippon Kayaku will sell Truxima, Celltrion’s biosimilar of…
Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information, RENFLEXIS® is indicated…
Celltrion announced last week that it has filed for marketing approval of Herzuma (trastuzumab) with Japan’s Ministry of Health, Labor and Welfare. Herzuma is indicated for the treatment of…
Lanka Business News is reporting that Celltrion and George Steuart Health have teamed up to launch Remsima (infliximab) in Sri Lanka. According to the article, this is the first biosimilar…
Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139, challenging U.S. Patent 6,627,196, and IPR2017-01140, challenging…
…posted here, here, and here, various amicus briefs have been submitted in Sandoz v. Amgen. Last week, Janssen Biotech, Inc. submitted an amicus brief in support of Amgen. Janssen’s brief…
Celltrion has filed petitions for inter partes review of two patents related to Genentech’s trastuzumab: IPR2017-01121, challenging U.S. Patent 7,846,441, and IPR2017-01122, challenging U.S….
As we previously reported, in Janssen v. Celltrion, Janssen appealed the district court’s partial final judgment that Janssen’s ‘471 patent, relating to monoclonal antibodies including…