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Washington, DC (Apr. 5)-The Pharmaceutical Research and Manufacturers of America joined the debate on follow-on biologics when senior vice-president Caroline Loew issued a statement recommending caution.
Washington, DC (Apr. 5)-The Pharmaceutical Research and Manufacturers of America (PhRMA, www.phrma.org) joined the debate on follow-on biologics when senior vice-president Caroline Loew issued a statement recommending caution.
While Loew maintains that PhRMA would support the establishment of a regulatory pathway for follow-on biologics, the organization worries that the current legislative proposals could put patient safety at risk. PhRMA cites the “significant differences between biologic products from different manufacturers” and the fact that innovator biologics are not identical to follow-on biologics as factors that could affect patients. In addition, PhRMA is concerned that existing legislation allows for a follow-on biologic to be replaced with a similar product, even though the similar product could have a different makeup, at pharmacies, hospitals, and physicians’ offices.
Loew goes on to state that clinical trials are necessary to prove the safety and effectiveness of follow-on biologics. Current legislative proposals regarding follow-on biologics do not call for clinical trials.
The debate over follow-on biologics stepped into the spotlight when the House Oversight Committee began hearings on March 26. The subject has drawn a large number of responses, including a statement from the Biotechnology Industry Organization (BIO, www.bio.org), which condemned the proposed “Access to Life-Saving Medicines Act” for “raising numerous patient safety concerns.” Meanwhile, Kathleen Jaeger, president and CEO of the Generic Pharmaceutical Association (GPhA, www.gphaonline.org), emphasized the US Food and Drug Administration’s (FDA, www.fda.gov) assertion that it has the scientific expertise to review generic biologics. A full article on the hearing can be viewed here.