Earlier this week, Hungarian pharmaceutical maker Gedeon Richter Plc. announced that is has withdrawn its Marketing Authorization Application for its pegfilgrastim biosimilar from the European Medicines Agency. According to the announcement, the Committee for Medicinal Products for Human Use (CHMP) expressed that “the data provided did not allow the Committee…
On Tuesday, Amgen filed its supplemental brief opposing Sandoz’s petition for writ and responding to the Solicitor General’s brief, which we discussed here. In sum, the Solicitor General sided with Sandoz, stating that: notice of commercial marketing before FDA approval is consistent with § 262(l)(8)(A); injunctive relief is not available…
The PTAB issued a Final Written Decision upholding the validity of Bristol-Myers Squibb’s U.S. Patent 8,476,239, which had been challenged by Momenta in IPR2015-01537. According to documents filed with the PTAB during the IPR, the ‘239 patent covers stable formulations of a protein called “CTLA4Ig.” This protein is sold by BMS under…
This morning, in the district court action in Janssen v. Celltrion, Judge Wolf issued an oral order denying the defendants’ motion for partial summary judgment of non-infringement of U.S. Patent No. 7,598,083 (“the ’083 patent”) as it relates to Celltrion, but ordered further briefing to the extent the motion concerns…
BioCND, a South Korean biopharmaceutical company, announced on Monday that it will begin clinical development in Korea of ranibizumab, a biosimilar of Genentech’s Lucentis® injection for patients with wet age-related macular degeneration (wAMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). Globally, other companies have already…
On December 16, 2016, Genentech filed preliminary responses in IPR2016-01693 and IPR2016-01694. Mylan filed both IPR petitions in August against patent 6,407,213, which covers humanized antibody polypeptides and methods for their preparation and use. The patent does not focus on any particular therapy, but Genentech notes that the approach was used to develop Herceptin®,…
The European Medicines Agency (EMA) is planning to launch a pilot project aimed at testing the value of tailored scientific advice for the development of biosimilar medicines. Based on the analysis of analytical and functional data provided by the applicants, the EMA will provide recommendations on which tests/studies should be…
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization to Celltrion’s Truxima (rituximab), a biosimilar to Roche’s Mabtherba, which is indicated for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, and microscopic polyangiitis. Truxima marks just the second recommended…
The Federal Circuit, over Celltrion’s opposition, has granted Janssen’s motion for a 30-day extension of time to file its opening appeal brief. Janssen’s opening brief is now due on January 26, 2017. Continue following Big Molecule Watch for more updates.
Eli Lilly and Boehringer Ingelheim announced today that their insulin glargine injection product, Basaglar® (a follow-on biologic for Sanofi’s Lantus®), is now available by prescription in the U.S. Although Basaglar is approved as a biosimilar for Lantus in Europe, in the U.S., Basaglar is not technically considered a biosimilar. In the U.S.,…