Biogen Inc. handily beat earnings expectations in its first-quarter 2020 earnings report to investors but leavened the good news by adding that it now plans to submit its BLA for beta-amyloid-targeting aducanumab for treating Alzheimer’s disease in the third quarter of 2020.
DBV Technologies SA officials took pains to reassure investors that data wanted by the FDA with regard to the BLA for Viaskin Peanut allergy therapy are already in hand and need only be turned over to the agency, but that didn’t stop shares (NASDAQ:DBVT) from sliding 55.7%, or $2.93, to close March 17 at $2.33.
Valrox (valoctocogene roxaparvovec) from San Rafael Calif-based Biomarin Pharmaceutical Inc. moved one step closer to entering the U.S. market, with the company reporting that that the FDA had accepted for priority review the BLA for its investigational AAV5 gene therapy for adults with hemophilia A.
With deeming day a little more than a month away, the FDA is taking final steps to ease the transition of simple proteins approved as new drug applications (NDAs) to biologic license applications (BLAs). The March 23 change will open drugs such as insulin and various hormones to new competition, likely bringing in the next wave of biosimilars. And this time, interchangeability could be riding the crest.
For the first time since Congress opened the door to biosimilars in 2010, the FDA approved nearly as many biosimilars in 2019 as it did new biologics. As the first decade of biosimilars came to a close, the agency’s Center for Drug Evaluation and Research (CDER) approved 10 biosimilars referencing seven blockbuster biologics, bringing the total number of approved biosimilars to 26.