Celltrion Healthcare Canada Limited announced yesterday that Health Canada granted a notice of compliance for Remsima SC®, an infliximab biosimilar of J& J’s Remicade®, for the treatment of adult patients with rheumatoid arthritis. Celltrion Senior Vice President Jovan Antunovic said the company is “delighted to bring the first subcutaneous form…
At its January meeting last week, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval for two biosimilar bevacizumab medicines, Alymsys and Oyavas. Mabxience Research SL’s Alymsys and STADA Arzneimittel AG’s Oyavas both received positive opinions for the treatment of carcinoma of the colon or rectum, breast cancer, non-small…
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…
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…
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…