Teva Pharmaceutical Industries Ltd., Celltrion, Inc. and Celltrion Healthcare announced that the companies have entered into an exclusive partnership to commercialize two of Celltrion’s biosimilar candidates: CT-P10, a proposed mAb biosimilar to Rituxan (rituximab), and CT-P6, a proposed mAb biosimilar to Herceptin (trastuzumab). Stay tuned to the Big Molecule Watch…
Yesterday, Celltrion filed a petition for inter partes review of Genentech’s U.S. Patent No. 7,976,838, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on updates for IPR2016-01667 and will post key documents on our IPR tracker page.
Yesterday, Celltrion filed a petition for inter partes review of Biogen’s U.S. Patent No. 7,820,161, which is directed to the use of rituximab to treat rheumatoid arthritis. We will continue to monitor and report on updates for IPR2016-01614 and will post key documents on our IPR tracker page.
The Korea Herald reports that Archigen Biotech, a joint venture between AstraZeneca UK and Samsung BioLogics, has applied for FDA approval to begin Phase I clinical trials for its rituximab biosimilar, SAIT101. Archigen Biotech’s website states that clinical trials for SAIT101 are expected to begin globally in Q3 of 2016.
Sandoz has announced plans to expand its biosimilars offerings within the next five years, including a total of 11 filings by the end of 2017, and 5 launches by 2020. Sandoz says that its next five launches will be biosimilars to Enbrel® (etanercept), Humira® (adalimumab), Neulasta ® (pegfilgrastim), Remicade® (infliximab)…
As we covered in an earlier post, the PTAB has instituted two IPR proceedings concerning patents related to Rituxan® (rituximab) (see IPR2015-00417 (U.S. Patent No. 7,976,838) and IPR 2015-00415 (U.S. Patent No. 7,820,161)). The PTAB had denied institution on a third rituximab IPR petition filed by Boehringer Ingelheim (see IPR2015-00418 (U.S. Patent No. 8,329,172))….
As we’ve covered in previous posts and in the IPR section of this blog, several IPR petitions have been filed against patents relating to the biologic products Humira (adalimumab) and Rituxan (rituximab). The PTAB has now issued decisions on whether it will institute IPR on the three Rituxan (rituximab) IPR…