Chip Davis named GPhA president, CEO
WASHINGTON, D.C. — The Generic Pharmaceutical Association has appointed Chester “Chip” Davis, Jr. as president and CEO, replacing current CEO Ralph Neas effective Aug. 18.
Davis has most recently led a pharmaceutical trade association’s government affairs and advocacy program, membership recruitment and retention efforts. Davis also brings experience from holding senior management roles at a global innovator drug company.
“It is a tremendous privilege to join the Generic Pharmaceutical Association and champion safe, effective and affordable generic drugs and biosimilars at the state, federal and international levels,” Davis said.
Davis emphasized the importance of discussions on promoting access while generating health savings.
“Generic drugs, and soon biosimilars, play a vital role in holding down costs, and this industry's record of savings and access must not only continue, but flourish,” he said. “I look forward to working with our member companies, regulatory partners, elected officials, the great team at GPhA, and all who stand to benefit from enhanced access to high quality, more affordable medicines.”
Davis holds a Juris Doctor from the University of Baltimore School of Law and serves on the Board of Directors for the Global Intellectual Property Center, the University of Delaware Alumni Association, the St. Mary’s High School Royal Blue Club, the Board of Directors for the DC Metro Area Chapter of Autism Speaks, in addition to the Member Advisory Board for the National Journal.
“I am thrilled to have Chip join the GPhA team. His leadership skills, policy experience and deep relationships on the Hill and across the industry provide an excellent foundation for his role as our next CEO,” Craig Wheeler, GPhA chairman of the board and CEO of Momenta Pharmaceuticals, said. “Most importantly, the vision and passion he has shown for the importance of our industry and our mission as we seek to expand on the benefits generic drugs have provided to countless lives and build on the billions of dollars generic medicines have saved our healthcare system have convinced me he will excel as our next leader.”
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Court ruling sets stage for Sandoz to launch first U.S. biosimilar
Sandoz’s Zarxio is a biosimilar version of Amgen’s Neupogen.
HOLZKIRCHEN, Germany — Novartis will be able to introduce Sandoz’s Zarxio (filgrastim) after Sept. 2, the U.S. Court of Appeal for the Federal Circuit ruled Wednesday. Once launched, Zarxio will be the first biosimilar drug in the U.S.
Part of the court’s decision said that a company whose biosimilar has been approved by the Food and Drug Administration must give notice of commercial marketing to the original drug maker 180 days before the intended launch. In the case of Zarxio, which the FDA approved March 6, the ruling allows for a launch anytime after Sept. 2.
“We welcome the Federal Circuit’s finding,” Sandoz’s Global Head of biopharmaceuticals and injectables Carol Lynch said.
Though Sandoz markets Zarxio as Zarzio in 60 countries, this will be the first biosimilar drug available in the U.S. following the passage of the Biologics Price Competition and Fairness Act in 2009.
“We look forward to launching Zarxio after September 2 as the first US biosimilar,” Lynch said.