Trade Organizations Take Opposing Views in Biosimilars Battles

Published Online: Monday, December 16, 2013
Two prominent trade organizations have taken opposing stances on the most recent issues within the biosimilars debate: California Governor Jerry Brown’s veto of a biosimilar substitution bill, and the international naming of biosimilar products.

The Biotechnology Industry Organization’s (BIO’s) and the Generic Pharmaceuticals Association’s (GPhA) diametric opposition on the issues follows a trend of disparate views between the groups. In both the California bill and the international naming debate, each side suggests the other’s view will lead to confusion and impede patient care.

The much-contested California bill, Senate Bill 598, would have allowed pharmacists to substitute biosimilar drugs; however, like similar pieces of legislation proposed in other states, the bill would require pharmacists to notify prescribing physicians and patients of the change. The bill initially passed in the state’s legislature in September 2013.

BIO’s disagreement with the veto hinges on its position that the drugs are not similar to traditional generics. The inability to exactly replicate the reference biologic—and the chance that even minute differences in biologic formulation could change its properties—necessitates the need for substitution legislation.

“While the FDA oversees approval of biologic medicines, policies governing whether one product may be substituted in place of a doctor’s prescription and whether a pharmacist must notify a consumer is covered by state law,” a press release from the organization read. “However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process.”

Meanwhile, GPhA supported the veto, stating that the bill would impede biosimilar access, and noting organizations supporting the veto, which included insurance plan organizations, at least 1 pharmacy benefit manager, state labor unions, the California Pharmacists Association, California Correctional Health Care Services, the California Public Employees Retirement System, and the California Pharmacists’ Association.

“The reason that such a diverse coalition opposed this bill and continues to oppose bills like this nationwide is simple—it adds unneeded burdens to the dispensing of biosimilar medications that will drive up costs,” GPhA president Ralph G. Neas said in a press release. “Governor Brown wisely recognized that there is no need to rush to legislate while the FDA is still developing guidelines for these new medicines.”

GPhA noted that similar substitution bills have been vetoed in 10 states this year, whereas 3 states enacted the bills with considerable amendments. Biosimilar substitution bills are pending in the Pennsylvania and Massachusetts state legislatures, according to GPhA’s state biosimilars map.

The organizations have also taken opposing viewpoints regarding naming standards for the products. GPhA recently reiterated its request for an international nonproprietary naming standard for biosimilar products at a World Health Organization (WHO) panel on the therapies. The standard would mimic the naming standard for traditional generic drugs and assure physicians and patients that the less expensive biosimilar product contains the same active ingredient as the reference product.

“Biosimilars represent an enormous opportunity to put many of today’s most life-changing medicines in reach for millions more patients,” Neas said in a press release. “It is critical that any decision on naming these products does not jeopardize that potential.”

BIO, on the other hand, noted its opposition to an international naming standard in a press release supporting a letter sent to FDA Commissioner Margaret Hamburg by 6 US senators. Naming standards for biosimilar products would cause confusion for patients and providers, among other problems, it contends.

“BIO strongly opposes naming products in a way that will create confusion for physicians and patients and will hinder effective pharmacovigilance,” the press release read. “Use of the same nonproprietary names suggests something that is not true for biosimilars—that they are the same as the innovator drugs they reference . . . Congress left it to the experts at [the] FDA to make the decision about product names—as the agency does for every other product. Reserving this to [the] FDA will allow for thorough consideration of technical, scientific, and patient safety issues involved.”


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