On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®. BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant...more
In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance. Pursuant to a law enacted...more
According to various reports, Celltrion has received approval from Health Canada for YUFLYMA, a biosimilar of AbbVie’s HUMIRA product. YUFLYMA was previously approved in Europe, and is a high-concentration, low-volume,...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
12/28/2021
/ AbbVie ,
Antitrust Litigation ,
Biosimilars ,
Fresenius ,
Generic Drugs ,
International Trade Commission (ITC) ,
Johnson & Johnson ,
Mylan Pharmaceuticals ,
Orange Book ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Proposed Legislation ,
Sanofi ,
Sherman Act ,
The Clayton Act
Last week, results of Tanvex’s phase III study on its trastuzumab biosimilar candidate (TX05) were published in connection with the European Society for Medical Oncology’s (ESMO’s) Congress 2021. The study compared the...more
Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim. The product will be offered in three dosage...more