As more biosimilars gain FDA approval for marketing in the United States, and more manufacturers launch programs to develop additional competitive biotech therapies, concerns have emerged that continued growth in this area could be limited by mounting pressure to push down on prescription drug outlays. Even though payers and insurers anticipate savings from alternative biotech therapies, the threat is that aggressive cost-cutting measures could raise the demand for truncated biosimilar development, eroding the confidence of physicians and patients about biosimilar safety and efficacy.
FDA is aware that mounting rage over drug pricing could have repercussion for biosimilar development. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), observed at a recent conference sponsored by the Biosimilars Council that gaining public trust in biosimilar safety and efficacy is key to building broad acceptance for these products, especially when patients are being asked to switch from a life-sustaining medicine that is working well. Woodcock emphasized the importance of requiring sufficient analytics and testing to convince prescribers and patients that new biosimilars are products that “can be relied upon.” FDA’s regulatory framework is based on a “totality of evidence” standard that she feels will help industry “earn the trust and confidence” of payers and prescribers.
FDA has approved three biosimilars for market, the latest just a week ago. As of the end of July 2016, … click to read full article on BioPharm International.
