Connecticut-based Alexion Pharmaceuticals, Inc. announced today that the FDA has accepted its supplemental Biologics License Application (sBLA) for SOLIRIS® (eculizumab) as a potential treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. According to Alexion, the submission is supported by phase III data…
On Monday, March 6, House Republicans unveiled their plan to repeal and replace the Affordable Care Act (“ACA”). Although the proposed legislation repeals or amends several provisions of the ACA, based on a preliminary review of the current key provisions, the Biologics Price Competition and Innovation Act (“BPCIA”) appears unaffected.
Coherus Biosciences has filed two petitions for inter partes review of Abbvie’s U.S. Patent 9,085,619. (IPR2017-01008 and IPR2017-01009). Coherus recently filed four other petitions for inter partes review of the ‘619 patent, as we’ve reported. Those cases are pending an institution decision. According to the petitions, the ‘619 patent is drawn…
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…