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…
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,…
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…
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…
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…
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….
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…
As 2020 comes to a close, Big Molecule Watch once again reviews the top developments in the biologics and biosimilars space for 2020. Please keep an eye out this week for posts identifying the most important regulatory, market, and legal developments impacting biosimilars. We start today with our picks for…
On December 27, the President signed the Consolidated Appropriations Act, which includes two provisions relevant to biosimilars: First, Section 322 of Division BB permits but does not require aBLAs to include information to show that the biosimilar’s conditions of use are the same as conditions of use approved for the…
As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies and covering the cancer therapeutic RITUXAN (rituximab), were unpatentable on obviousness grounds. After appealing to…