Yesterday, Hospira filed two petitions for inter partes review of Genentech’s U.S. Patent 7,371,379 (IPR2017-00805) and U.S. Patent 6,627,196 (IPR2017-00804). According to the petitions, these patents are directed to methods of treating certain cancers with trastuzumab, sold under the name Herceptin®. These petitions follow closely on the heels of three…
On Friday, Hospira filed the following petitions – IPR2017-00731 (U.S. Patent No. 7,846,441), and IPR2017-00737 and IPR2017-00739 (both for U.S. Patent No. 7,892,549). According to these petitions, the patents are drawn to methods of using trastuzumab in combination with certain other agents for the treatment of cancers. Trastuzumab is the active…
As we previously reported, in November Mylan and Biocon submitted an aBLA to the FDA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Today, Mylan announced that the FDA has accepted its Mylan-Biocon’s aBLA. This is Mylan and Biocon’s first U.S. regulatory submission through the 351(k) pathway. The anticipated…
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®,…
Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American Medical Association (JAMA), titled Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2…
Today, Pfizer reported that their trastuzumab biosimilar to Roche’s Herceptin® has shown equivalence in a Phase 3 clinical trial measuring objective response rate (ORR) when taken in combination with paclitaxel to treat HER-positive metastatic breast cancer patients. Pfizer also reported success in a separate study, REFLECTIONS B3271004, evaluating this biosimilar in early…
On November 8, 2016, Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). According to the Mylan press release, this submission is Mylan’s first for a biosimilar in the United States, and may lead to the first approved trastuzumab biosimilar in the United States. Mylan…
According to The Korea Herald, the South Korean biopharma company Celltrion submitted their Herceptin biosimilar, Herzuma, to the European Medicine Agency for approval. Herzuma, a biosimilar to Roche’s breast cancer drug Herceptin (trastuzumab), was approved in Korea two years ago for the treatment of metastatic breast cancer, early stage breast…
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…
On September 16, Hospira filed a petition for an inter partes review of Genentech’s U.S. Patent No. 7,807,799 which is directed to methods of purifying proteins, including trastuzumab. Trastuzumab is marketed by Genentech under the brand-name Herceptin®, and is indicated for the treatment of certain sub-types of breast cancer. The petition…