On January 28, 2021, Bio-Thera Solutions announced that the Food and Drug Administration (FDA) accepted its Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin® (bevacizumab). The BLA seeks approval of BAT1706 for the treatment of diseases for which the US-licensed Avastin is approved, including metastatic colorectal cancer…
We have concluded our webinar 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 series provided an opportunity to dive deep into some of the key topics…
On January 13, 2021, EVOQ announced a license and collaboration agreement with Amgen for the development of new drugs for autoimmune disorders. According to the press release, Amgen and EVOQ will collaborate on preclinical development and Amgen will be responsible for clinical development and commercialization. Amgen’s portfolio includes biosimilars AMGEVITA…
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…