While the Biosimilars Council, a division of the Generic Pharmaceutical Association (GPhA), applauds the Food and Drug Administration's (FDA) current discussions on the next Biosimilar User Fee Act (BsUFA), it hopes to collaborate even more with the FDA on biosimilar medications.
Although the FDA has initiated the process for biosimilar progression, the current approval rate for biosimilar medications is lower than the agency had originally projected. GPhA is asking for the FDA and pharmaceutical industry leaders to work together to provide high-quality biosimiliars for the patients who rely on them.
Moving forward, the Council is making arrangements to provide greater opportunities for prescribers, providers and patients to learn more about biosimilar medications.
“More collaborative independent public information and education efforts can better inform patients and professionals about biosimilar safety and scientific development,” Davis said. “That is why the Biosimilars Council efforts in 2016 will include opportunities for prescribers, providers and others to learn more about these vital medicines.”
Launched earlier this year, the Biosimilars Council works to promote a positive environment for patient access to biosimilar pharmaceuticals. The committee is currently pressing for the FDA’s approval of new authorizations on 2012’s BsUFA.
“As the biosimilars market in the United States is in its early stages, it is critical that policies established promote competition and create opportunities to speed patient access to safe, effective alternatives to costly brand biologic drugs,” President and CEO of GPhA Chip Davis said.