According to a Pfizer press release, the FDA has issued a second Complete Response Letter (CRL) to Pfizer in connection with the company’s aBLA for Retacrit, a proposed biosimilar of Epogen® and Procrit® (epoetin alpha). Pfizer said the CRL relates “to matters noted in a Warning Letter issued on February…
On June 6, 2017, Biocad, a Russia biotechnology company, announced that it has obtained marketing authorization for its rituximab biosimilar in Bolivia and Honduras under the trade name USMAL, and that shipments will start in the beginning of Q3 2017. Biocad further stated that it is registering its rituximab biosimilar…
PlantForm Corporation, a Canadian biotech firm, has announced that it will begin construction this summer on a new biopharmaceutical lab in Rio de Janeiro with its partner, Brazil-based Axis Biotec Brasil. According to PlantForm’s press release, the joint venture, known as PlantPraxis, “will first develop a biosimilar version of adalimumab (Humira®)…
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…
On Wednesday, June 28, 2017, at 12:00 PM EST, Goodwin will host a webinar discussing the Supreme Court’s Decision in Sandoz v. Amgen. On June 12, the Supreme Court decided Sandoz v. Amgen, which presented the Justices with multiple significant questions about the correct interpretation and application of the biosimilars…