Biosimilar development must rely on science to realize access and savings, says GPhA

Patient access to biosimilar medicines will hinge on critical policy decisions around extrapolation and biosimilar label content, asserts the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA) in comments to the Food and Drug Administration’s Arthritis Advisory Committee.

Christine Simmon, senior vice president of the GPhA, and executive director, Biosimilars Council, is presenting LINK in two public meetings on July 12-13 to the FDA Advisory Committee which is convening to discuss pending applications for two rheumatoid arthritis biosimilars.

“The Biosimilars Council commends the FDA’s work toward creating a regulatory environment that maximizes patient access to biosimilars,” said Ms Simmon, adding: “The Council is confident in the FDA’s robust and rigorous scientific approach to biosimilars and applauds the agency’s efforts to educate providers and patients so they can be confident in these medicines and access them at a lower cost.”