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5 reasons to keep biosimilar names the same


The Healthcare Supply Chain Association (HSCA), the Generic Pharmaceutical Association (GPhA), and other healthcare stakeholders are calling on FDA to institute a clear policy for biologics and biosimilars.

The Healthcare Supply Chain Association (HSCA), the Generic Pharmaceutical Association (GPhA), and other healthcare stakeholders are calling on FDA to institute a clear policy for biologics and biosimilars.

Related:FDA approves first biosimiar Zarxio

“Formulary managers should be aware that FDA has not yet issued a formal policy regarding the naming of biosimilars. They should be alert to the fact that FDA has not come out with a comprehensive naming policy for these important medicines and that it is not too late to weigh in with the agency,” said Curtis Rooney, HSCA president.

“We want biologics and biosimilars to be able to share the same name to ensure patient safety and avoid confusion among providers and dispensers,” he said.

This spring FDA approved the first biosimilar drug which began a new era for the pharmaceuticals market and, more importantly, patients, according to Rooney.

“This approval ensures that safe and affordable alternatives to life-saving biologics are now a reality, and we commend FDA for making it clear that the provision of a placeholder International Nonproprietary Name [INN] for Zarxio, the first biosimilar, does not represent the Agency’s decision on a comprehensive naming policy for these medicines.”

In addition, there are at least 4 other biosimilar applications currently pending FDA approval, according to Rooney.

Related:New forum expands access to biosimilars

There are 5 reasons that biosimilars should use the same INNs, according to Rooney.





To ensure patient safety. “This is the number one reason we want FDA to allow biologics and biosimilars to use the same name or INN,” said Rooney.



To minimize confusion. “Using the same name as the rest of the world will prevent confusion in the global market and here at home,” Rooney said. “Avoiding any departures from the accepted standards under the INN system is sound policy.”




To cut down on the complexity. “We think that the current mechanisms in place-eg, NDC code, lot number, brand name, manufacturer, etc.-allow for the tracking of important safety information related to new biosimilar products,” he said. “Creating new names for the same products would make these mechanisms unnecessarily complex.”




To be in line with current safety alert systems. “Unnecessary changes to a drug’s name may interfere with current pharmacy safety alert systems used in retail and community pharmacies,” Rooney points out. “Adverse events and product recalls for small-molecule and biologic drugs are currently identified using the national drug [NDC] code and lot number. Biosimilars should be handled the same way.”



To aid in patient access. “Having the same name will help to avoid the unintended effect of impeding patient access to and slowing the uptake of these potentially cost-saving products, which we believe is the legislative intent of the biosimilar approval pathway included in the Patient Protection and Affordable Care Act,” said Rooney. “Requiring different INNs would create an unnecessary barrier to the benefits of FDA determined interchangeability.”

“Patients, prescribers and dispensers of these drugs need to be able to easily identify which drugs bear a relation to one another in order to maximize the potential savings from the biosimilar approval pathway,” Rooney said.

Read next:[BLOG]: FDA approves first biosimilar in US, may lead to easier access to biologic medications for patients

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