On November 18, 2020, companies Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the United States Food and Drug Administration (“FDA”) accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Genentech, Inc. product Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy for retinal vascular disorders, which are
Pharmaceutical companies Biocon Biologics and Mylan announced at the end of last month the U.S. launch of their long-acting insulin glargine product Semglee. Semglee was approved in June as an equivalent to Sanofi’s reference product insulin glargine, Lantus.
The companies are launching Semglee at a “65% discounted list price,” calling it the lowest wholesale acquisition
Pharmaceutical companies Teva Pharmaceutical Industries Ltd. and Alvotech announced on Wednesday, August 5, 2020, that they will be entering into an exclusive partnership for the commercialization of biosimilar products in the United States. This partnership aims to combine Teva’s long-standing commercial presence and extensive infrastructure in the U.S. market with Alvotech’s scientific experience and state-of-the-art
In February, the U.S. Food and Drug Administration (“FDA”) and the Federal Trade Commission (“FTC”) published a joint statement regarding collaborative efforts to promote competition in the marketplace for biological products – including biosimilars and interchangeable products – by identifying joint goals both agencies will work to achieve, as well as measures to be taken