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On January 6, 2021, Everest Medicines (HKEX 1952.HK) announced that the National Medical Products Administration (NMPA) of the People’s Republic of China approved a Clinical Trial Application (CTA) for sacituzumab govitecan-hziy for the treatment of patients with metastatic urothelial cancer (mUC).  With this CTA, Everest Medicines plans to enroll patients in China as part of the Phase 3, global, multicenter, open-label randomized controlled TROPiCS-04 trial.  Patients will be randomized to receive either sacituzumab govitecan-hziy or Treatment of Physician’s…
We are pleased to present the final webinar in this first series relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S., which provides expert guidance and practical know-how for lawyers working in this growing area of the law. This webinar, An Overview of the Biosimilars Market in China, will take place Wednesday, January 19th. Goodwin’s Huiya Wu and Freddy Yip will provide an overview of the players, products, and regulatory and…
The FDA has deferred its decision on the biologics license application for MYL-1402O, Mylan and Biocon’s biosimilar to Avastin® (bevacizumab).  In a December 25th, 2020 company statement, Biocon cited the FDA’s need for more time to inspect the manufacturing facility.  Such an inspection, which is a required step of the standard review process, could not be completed during the current review cycle due to restrictions on travel related to COVID-19.  The FDA had initially
Sanofi announced that it has entered into an agreement to acquire Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics, for an upfront payment of approximately $1.1 billion and up to $350 million upon achievement of certain milestones.  The acquisition will give Sanofi full global rights to Kymab’s KY1005, which binds to OX40-Ligand and has the potential to treat a wide variety of immune-mediated diseases…
On January 5, 2021, the President signed H.R. 1503 (the Orange Book Transparency Act of 2020).  The Orange Book Transparency Act of 2020 clarifies information related to patent listing and the types of patents that should be listed in the Orange Book.  The Act also requires that NDA holders notify FDA within 14 days of a final decision if an Orange-Book listed patent is invalidated by the PTAB or a court, and that, FDA remove…
Last week, Alvotech closed out the year with an announcement that it is expanding its high-tech center in Reykjavik, Iceland.  This high-tech center, which will almost double the size of the existing facility by the end of 2022, will house “biosimilar development, drug refills, offices and warehouse, in addition to facilities that the company will provide to the University of Iceland’s Biotechnology Department.” Celltrion closed out its year announcing plans for a global phase 3…
In July we reported that the presiding Administrative Law Judge recommended issuing an exclusion order blocking the importation of Jeuveau® (prabotulinumtoxinA-xvfs), Evolus’s follow-on biologic to Allergan’s Botox® (onabotulinumtoxinA injection).  Since that time, the parties have submitted lengthy Petitions for Review and answered questions raised by the Commissioners.  Now, the Commission has ruled. On December 16, the Commission issued its confidential opinion, which was accompanied by a three-page public notice of final determination.  The confidential…
As we ring in the new year, we look back at the top U.S. biosimilar market developments of 2020. Here are some of our highlights, in no particular order: 1. Pfizer Announces Launches and Pricing Information for Three U.S. Biosimilars In January, Pfizer announced that it has launched three new biosimilars in the United States: ZIRABEV (bevacizumab-bvzr), RUXIENCE (rituximab-pvvr), and TRAZIMERA (trastuzumab-qyyp).  At the same time, Pfizer announced WAC prices for each of the…
As we close out another calendar year, we look back at the top legal developments of 2020 that could influence the market for biologics and biosimilars. While there were a number of case-specific decisions this past year that, undeniably, impacted the availability of biosimilars in the market, the five legal decisions and developments below will likely impact the legal strategy in the biosimilars space in 2021 and moving forward. 1. While the “Consolidated Appropriations Act”…
The SEC, in one of the Commission’s final acts under the leadership of Chair Jay Clayton, approved enforcement action aimed at Ripple Labs, Inc. (“Ripple”) and two of its executives, Brad Garlinghouse and Chris Larsen. The SEC filed its complaint on December 22, 2020 in the Southern District of New York, alleging that sales of XRP during a period ranging from 2013 through 2020 constitute an ongoing unregistered offering of securities in violation of Section…