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 humanized monoclonal IgG2/4κ antibody that binds to the human c5 complement protein. SOLIRIS® is approved for the treatment of paroxysmal…
Earlier this week, Shanghai Henlius Biotech, Inc. announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay S.R.L. for the commercialization of HANLIKANG (rituximab) and HANQUYOU (trastuzumab, trade name in Europe: Zercepac®), two products developed by Henlius, in Brazil. According to the announcement, Abbott will pay…
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 in late 2020, a reference product sponsor must now provide patent information to FDA for listing in the Purple Book…
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, citrate-free formulation of adalimumab.
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 court, at the Federal Circuit, at the PTAB, and even at the ITC. Biosimilars…
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 efficacy and safety of TX05 to Herceptin in patients with HER2+ early breast cancer. The poster provides the…
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 strengths and is indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults. ITP is a…