On September 25, 2019, Tanvex BioPharma announced that it received a complete response letter from the U.S. FDA indicating that Tanvex’s abbreviated Biologics License Application (aBLA) for its proposed filgrastim biosimilar, TX01, was not in condition for approval. Tanvex reported that FDA “did not request additional clinical data or express…
Last month, Biocad and Shanghai Pharma Holding (SPH) announced that they have established a joint venture, SPH-Biocad, to commercialize Biocad’s biopharmaceutical portfolio in China. According to the companies’ press releases, SPH-Biocad will begin by commercializing six of Biocad’s biopharmaceutical products, including three biosimilars and three innovative biologics. According to SPH,…
As we previously reported, earlier this year Kashiv Biosciences filed two inter partes review (IPR) petitions challenging certain claims of Amgen’s U.S. Patent Nos. 8,940,878 and 9,643,997, which are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system. Amgen is asserting the ’878 and…
Last week, the FDA compiled a preliminary list of NDAs that will be converted to BLAs in view of the new interpretation of the terms “protein” and “biological product” in the FDA’s “Deemed To Be A License” draft guidance, which was released in December 2018. In the draft guidance, the…
On September 17, Russian drug manufacturer Generium announced that its dornase alfa biosimilar, Tigerase®, has been approved and launched in Russia. Tigerase® references Genentech’s Pulmozyme® and is the first dornase alfa biosimilar to be approved in any market worldwide. Dornase alfa is used in combination with other therapies to improve…
On September 25, 2019, Shanghai Henlius Biotech, Inc. (2696. HK) completed its US$410 million initial public offering and listing on the main board of the Stock Exchange of Hong Kong, marking the largest biotech IPO in Hong Kong this year. According to Henlius’ Global Offering, China International Capital Corp., Bank…
Over the summer, Goodwin and Bristows sat down with senior in-house counsel at the forefront of the biosimilars industry to discuss the pace of biosimilars market entry in the EU and U.S., why it has been so different in those two markets, and what the future holds. In the first…
On September 20, 2019, the District Court for the District of Delaware endorsed a joint stipulation of the parties to dismiss all claims and counterclaims in the Genentech v. Pfizer BPCIA litigation concerning Pfizer’s ZIRABEV (bevacizumab-bvzr), a biosimilar of AVASTIN. According to the stipulation, the parties entered into a settlement…
As we previously reported, Amgen filed a complaint against Adello Biologics and Amneal alleging infringement of several patents, including certain claims of U.S. Patent No. 8,952,138, directed to a protein refolding process. In their answer, Adello sought a declaratory judgment that certain claims of the ’138 patent were not infringed…
Below are some highlights of recent biosimilar development news from this week: On September 20, Mochida announced that it had obtained marketing approval in Japan for RGB-10, a biosimilar of FORTEO (teraparitide) that Mochida developed in Japan based on a comprehensive license and collaboration agreement with Gedeon Richter Plc. Mochida…