We previously reported that Sanofi and Regeneron filed a declaratory judgment action seeking a ruling that its approved Dupixent® (dupilumab) product does not infringe Amgen’s U.S. Pat. 8,679,487 (“the ’487 patent”), and that Immunex, a wholly owned subsidiary of Amgen, later filed a complaint against Sanofi and Regeneron alleging that…
As we reported yesterday in the Amgen v. Hospira litigation, Amgen filed a motion for leave to file an amended brief in support of its Motion for a Preliminary Injunction, in light of the Supreme Court’s ruling in Sandoz v. Amgen. That same day, the Court entered an order granting…
As we previously reported in the dispute brought by Janssen against Hospira and Celltrion regarding infliximab, Defendants filed a motion to dismiss the 2015 and 2016 consolidated actions for lack of standing. In those actions, Janssen asserted infringement of the ‘083 patent (as well as other patents which were later…
As we previously reported in the Amgen v. Hospira district court litigation regarding Hospira’s proposed biosimilar of Epogen®/Procrit® (epoetin alfa), Amgen filed a motion for preliminary injunction seeking to enjoin Hospira from launching its biosimilar “until Hospira has complied with the requirement of 42 U.S.C. § 262(l)(8)(A)” (the notice of…
As we previously reported, the Nebraska legislature had been considering a bill that would allow automatic substitution of “interchangeable” biosimilar products where a physician prescribes a biologic product. Last month, the legislature passed that legislation by a vote of 47-0-2 and Governor Pete Ricketts signed the bill into law, making Nebraska…
Sandoz announced today that it has received approval for the use of Rixathon® in Europe. Rixathon® is a biosimilar version of Roche’s MabThera® (rituximab) and is approved for use in all the same indications, including non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large B-cell lymphoma), chronic lymphocytic leukemia, and immunological diseases…
At the EULAR Annual Congress this week, Rieke H.E. Alten, MD, working at the University of Berlin, presented data from a randomized, double-blind, Phase III study comparing adalimumab and FKB327, Fujifilm Kyowa Kirin Biologics’ proposed biosimilar, in 730 patients with active rheumatoid arthritis (RA) inadequately controlled on methotrexate. The study concluded…
Today, Boehringer Ingelheim announced the 24-week results from the Phase III VOLTAIRE®-RA study, comparing the adalimumab biosimilar candidate BI 695501 to Abbvie’s Humira® in patients with moderate- to severely-active rheumatoid arthritis. According to BI, the results indicate that BI 695501 has similar efficacy, safety, and immunogenicity as Humira® in these…
Celltrion Healthcare presented new data on their Rituximab biosimilar Truxima® (CT-P10) at the International Conference on Malignant Lymphoma (ICML) in Switzerland and the European League Against Rheumatism (EULAR) Congress 2017 in Spain. According to the presentation, data from a randomized, double-blind, controlled phase III study in 140 patients indicate that Truxima®…
We previously reported that the PTAB upheld the validity of Bristol-Myers Squibb’s ‘239 patent covering their rheumatoid arthritis agent Orencia® (abatacept). Since 2008, Orencia® has only been approved for use in patients 6 years of age and older with moderately to severely active polyarticular Juvenile Idiopathic Arthritis (JIA). However, last…