Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that there were no clinically meaningful differences in the safety profile of Cinfa Biotech’s B12019 biosimilar to Neulasta® (pegfilgrastim) compared with…
On December 29, Mylan and Biocon announced that their trastuzumab biosimilar, Zedora, was approved by Brazil’s National Sanitary Surveillance Agency. Zedora, a biosimilar of Genentech and Roche’s Herceptin, is indicated for the treatment of overexpressing HER2-positive metastatic breast cancer, HER2-positive early stage breast cancer, and HER2-positive advanced gastric cancer. Zedora…
Here are our picks for the top-5 biggest deals in the world of biosimilars in 2017: 5. Companies developing biosimilar products continue to establish partnerships to market and distribute the products on a regional basis. For example, Celltrion and Nippon Kayaku entered into an agreement under which Nippon Kayaku will sell Truxima®, Celltrion’s…
Yesterday, Samsung Bioepis announced that the FDA has accepted for review the company’s BLA under the 351(k) pathway for SB3, a biosimilar candidate referencing Genentech’s Herceptin® (trastuzumab). The press release states that this is Samsung Bioepis’ first submission for FDA-approval of an oncology biosimilar candidate. According to the press release,…
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and Pfizer’s petitions (IPR2017-01488 and IPR2017-01489 [decisions under seal]) challenging Genentech’s Carter patent, U.S. Patent No. 6,407,213, directed to humanized antibodies. This same patent…
Today, the FDA announced that it has approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar to Genentech and Roche’s Herceptin (trastuzumab). Ogivri is indicated for adjuvant treatment of breast cancer and treatment of metastatic breast cancer or stomach cancer in patients whose tumors overexpress the HER2 gene. Ogivri is the first biosimilar version…
Below is our fall update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our BPCIA Litigation Summary Chart or our previous quarterly updates (Summer 2016, Fall 2016, Midwinter 2017, Spring 2017, Summer 2017).
Genentech filed a complaint last Friday in the District of Delaware against Pfizer for infringement of 40 patents under the BPCIA regarding PF-05280014, Pfizer’s biosimilar of Herceptin® (trastuzumab). According to the complaint, the FDA accepted Pfizer’s aBLA for review on August 21, 2017. Genentech’s complaint acknowledges that the parties had started, but not completed, the information exchanges of the…
Samsung Bioepis announced today that the European Commission (EC) has granted marketing authorization for Ontruzant®, a biosimilar for Herceptin® (trastuzumab), across all 28 European Union member states and the European Economic Area member states of Norway, Iceland and Liechtenstein. According to the press release, Ontruzuant® is approved for the treatment of…
The PTAB remains a busy venue for biologics patents. Here are some IPR updates from the weeks since our last IPR update: HERCEPTIN On October 4, the Board instituted IPR on four petitions that Celltrion had filed on Genentech patents related to Herceptin® (trastuzumab): IPR2017-01121 (challenging U.S. Patent 7,846,441); IPR2017-01122 (challenging U.S. Patent No….