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FDA Accepts Bio-Thera Solutions’ Biologics License Application for BAT1706, a Proposed Biosimilar to Avastin®

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…

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That’s a Wrap – Biosimilars Guide Webinar Series

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…

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Recent Biosimilars Deals

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…

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Everest Medicines Announces Approval of Clinical Trial Application by China National Medical Products Administration for Phase 3 Registration Trial of Sacituzumab Govitecan-Hziy for Metastatic Urothelial Cancer

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…

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Commission Issues Exclusion Order in Botox Trade Secret Case

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….

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