Following the string of biosimilar agreements announced in early November, a number of additional transactions were announced in early December, bringing 2019 to a roaring close with global biosimilars deals. On December 1, 2019, Luye Pharma Group announced that it acquired Shandong Boan Biological Technology Co. Ltd. (Boan), strengthening its…
Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s denial of preliminary injunctions in cases brought by Genentech against Amgen regarding Amgen’s bevacizumab and…
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order: 1) Launch of First and Second U.S. Trastuzumab Biosimilars: In July 2019, Amgen and Allergan announced the U.S. launch of KANJINTI (trastuzumab-anns),…
As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy in the biosimilars space in 2020 and moving forward. 1. On December 16,…
Following last month’s dismissal of the Amgen v. Kashiv filgrastim biosimilar litigation, yesterday Amgen and Tanvex filed a joint stipulation of dismissal in their BPCIA litigation concerning Tanvex’s filgrastim biosimilar candidate. The stipulation states that the parties agree “to the dismissal, without prejudice, of all remaining claims and counterclaims in…
Below are highlights of recent developments in biosimilar clinical trials. On December 9, Celltrion presented the results from a phase 3 clinical trial that demonstrated similar safety and efficacy of its TRUXIMA biosimilar to the reference product RITUXAN (rituximab) in patients with advanced follicular lymphoma (AFL). On December 10, Samsung…
Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification. Prequalification is “a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.” The WHO noted that the global average price of…
This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa). On…
On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994. According to CNBC, the final version does not include a 10-year data exclusivity period for biologic drugs that was part…
As previously reported, earlier this year Fresenius filed a petition for inter partes review of claims 9-10, 13-21 and 23-30 of Amgen’s pegfilgrastim patent – U.S. Patent No. 9,643,997 (“997 patent”). The challenged claims of the ’997 patent relate to methods for purifying proteins of interest expressed in a non-native…