Below is our first quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017).
Below is our first quarter update on the U.S. patent litigations concerning proposed or approved biosimilar products. For additional details, please consult our previous quarterly updates (Q3 2016, Q4 2016, Q1 2017, Q2 2017, Q3 2017, Q4 2017).
Sources are reporting that Korean pharmaceutical company Daewoong Pharmaceutical announced today that it has launched Samfenet, a biosimilar to Roche’s HERCEPTIN® (trastuzumab), in Korea. Samfenet is priced at a 29.5-percent discount to Herceptin, which amassed around $6.5 billion in global revenue last year. Mylan announced last week that it has…
Clover Biopharmaceuticals, a clinical-stage biotech company based in Chengdu, China, and General Electric announced last week that Clover had selected General Electric’s FlexFactory biomanufacturing platform for Clover’s new manufacturing facility, to be located in the Changxing Economic and Technological Development Zone. The facility, which is scheduled to open in the second half of 2018, will feature…
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…
Yesterday, Momenta Pharmaceuticals and Mylan announced a development strategy for M710, a proposed biosimilar of Regeneron’s Eylea® (aflibercept), including their plan to initiate a pivotal clinical trial in the first half of this year. According to the joint press release, the trial will be a randomized, double-blind, active-control, multi-center study in…
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…
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017: 1. Compared to three approvals in 2016, the FDA approved five biosimilar products in 2017: Renflexis® (infliximab-abda) Cyltezo® (adalimumab-adbm) Mvasi® (bevacizumab-awwb) Ogivri® (trastuzumab-dkst) Ixifi® (infliximab-qbtx) In a press release regarding the approval for…
Below are IPR updates from this week. LANTUS On December 13, 2017, the Board instituted two IPRs on Mylan’s petitions (IPR2017-01526 and IPR2017-01528) challenging Sanofi’s U.S. Patent Nos. 7,713,930 and 7,476,652, respectively, both related to insulin glargine. As we have reported, both patents are the subject of litigation pending in the…
On Friday, Biocon and Mylan announced that the European Medicines Agency has accepted applications for their proposed trastuzumab and pegfilgrastim biosimilars. As we previously reported, Biocon had earlier requested withdrawal and resubmission of these applications, which it said was part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s…