WASHINGTON The Biotechnology Industry Organization has asked the Obama administration and members of Congress to disregard a request by the Generic Pharmaceutical Association to strike biosimilars language from the healthcare-reform bill.
In a letter to President Barack Obama Tuesday, GPhA president Kathleen Jaeger asked Obama to urge Congress to either reduce the 12-year period of market exclusivity provided in the bill’s language, determining the amount of time a potential manufacturer would have to wait before making a biosimilar to compete with the innovator company’s product, or eliminate the biosimilars language from the bill altogether.
“GPhA’s request to the administration is a cruel trick to the millions of patients who are awaiting the benefits of biosimilars,” a BIO statement in response to the letter read. “GPhA is asking the Obama administration to hold patients and consumers hostage unless it gets its way on this critical provision of healthcare reform.”
BIO has stated that it prefers an exclusivity period of 14 years, saying that the unique properties of biosimilars would allow a potential biosimilar manufacturer to circumvent an innovator company’s patents and arguing that additional time is needed to determine whether a biosimilar would have the same safety and efficacy as its innovated counterpart. GPhA, meanwhile, wants five-year exclusivity periods, similar to the ones that pharmaceutical drugs have before facing generic competition. GPhA says that 14-year exclusivity periods would deprive patients of more affordable alternatives to biotech drugs, which can cost tens of thousands of dollars per year. The Obama administration has called for a seven-year exclusivity period.
“Biosimilars, often erroneously referred to as ‘generic biologics,’ can bring the benefits of expanded competition to biologics, breakthrough medicines that are extending and saving the lives of patients living with diseases such as cancer, diabetes, Parkinson’s and Alzheimer’s,” BIO’s statement read.