Yesterday, Coherus announced that CHS-1420, its proposed biosimilar of Humira® (adalimumab), met the primary endpoint in a clinical pharmacokinetic (PK) bioequivalence study that compared CHS-1420 to Humira. According to Coherus, the study showed clinical PK similarity on all prospectively defined PK endpoints. It was reported that both agents were well tolerated and that…
We previously reported that the Committee for Medicinal Products for Human Use (CHMP) had recommended that the European Medicine Agency (EMA) grant marketing approval for Truxima (CT-P10), Celltrion Healthcare’s biosimilar of Roche’s monoclonal antibody product MabThera (rituximab). Last week, the EMA authorized Truxima for all the approved therapeutic indications of…
As we previously reported, yesterday Judge Sleet, United States District Court for the District of Delaware, heard arguments on Amgen’s motion to dismiss in Genentech v. Sandoz. The court orally granted Amgen’s motion under the Federal Circuit’s holding in Amgen v. Sandoz. The court dismissed Genentech’s complaint in its entirety without prejudice and with leave to amend…
Last week, the New Mexico Senate passed a bill that would amend New Mexico’s existing automatic substitution law for small molecule drugs to allow “a pharmacist to dispense any one of the … interchangeable biological products that satisfied the final determinations so recognized and listed by the federal department of…
As we previously reported, Genentech earlier this month filed a declaratory judgment action against Amgen. In this litigation, Genentech claims that Amgen has violated the patent dance provisions of the BPCIA by disclosing its aBLA for a proposed biosimilar of Genentech’s Avastin® (bevacizumab) but refusing to provide additional manufacturing information…
As we previously reported regarding Janssen v. Celltrion, after the district court postponed trial and heard oral argument on the damages issues related to Celltrion’s challenge to Janssen’s standing, the Court set a deadline for Celltrion to file a motion to dismiss on that basis. On Friday, February 22, 2017, Celltrion filed its Motion…
The PTAB has granted Celltrion’s petition for inter partes review of Biogen’s U.S. Patent 7,820,161. (IPR2016-01614) The patent is drawn to methods of treating rheumatoid arthritis by administration of rituximab. Rituximab is sold by Biogen and Genentech under the trade-name Rituxan®. Rituxan is FDA approved to treat non-Hodgkin’s lymphoma, chronic…
As we have previously reported, in April the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions. As we reported last week, several amicus briefs in support of Sandoz were filed last week. The amicus brief, filed by…
As we covered in previous posts, the Supreme Court will hear arguments regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions in April 2017. Several amicus briefs in support of Sandoz were filed last week, including by AARP and AHIP. Mylan, Inc. (“Mylan”), Apotex…
As we have previously reported, the Supreme Court will later this year hear arguments in Sandoz v. Amgen regarding the Federal Circuit’s interpretation of the BPCIA’s notice of commercial marketing requirement and patent dance provisions. Several amicus briefs in support of Sandoz were filed last week. One brief was filed by AARP,…