On May 1st, ASBM Executive Director, Michael Reilly, Esq. and Advisory Board Chair, Philip Schneider, MS, FASHP; presented before the 66th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances in Geneva, Switzerland. This was the tenth INN Consultation at which ASBM has presented since 2013. While the discussions in the Open Session at which ASBM presented are […]
On May 15th, the U.S. Food and Drug Administration approved its tenth biosimilar, Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection. Retacrit is also approved for use before and after surgery to reduce […]
On April 11th in Washington DC, nearly 25 individuals gathered to be part of an exclusive roundtable to discuss a global approach for naming harmonization of biologic medicines. Representatives from the U.S. Food and Drug Administration, Health Canada, physician and pharmacist associations, and patient advocacy organizations convened to explore the feasibility of this endeavor and […]
