Regulatory Focus™ > News Articles > Pharmacovigilance Concerns Lead Group to Call for Unique Names for Biosimilars

Pharmacovigilance Concerns Lead Group to Call for Unique Names for Biosimilars

Posted 17 September 2012 | By

A new survey released by the Alliance for Safe Biologic Medicines (ASBM), a group supported by branded biologics companies, says that biosimilar medicines should be required to use distinct names to differentiate themselves from their innovative biologic counterparts.

Biosimilar medicines are effectively generic biologics, but have some key differences relative to their chemical drug generic counterparts. For one, biologic medicines are not exactly reproducible by generic manufacturers. Though the end product is likely to be nearly identical to the original product, small differences in the protein structure of the product could potentially cause differences in the safety and efficacy of the drug.

The importance of these differences will be emphasized when considering the safety of these medicines, both from a prescribing and pharmacovigilance perspective.

Naming in Support of Pharmacovigilance Activities

ASBM's study, an Internet-based survey of 376 US-based prescribers, found nearly a fifth of prescribers refer to the generic name of a drug, including biologics, when recording its use in a patient's charts. This could be problematic for US regulators and manufacturers trying to conduct pharmacovigilance activities on biosimilar medicines, argues the group. Because many regulatory databases rely on billing data submitted by healthcare providers, officials would be unable to determine if a patient had been prescribed the biosimilar medication or the original biologic.

It would be unfair to both patients and the innovators if physicians were unable to distinguish between the two products, which could lead to billing and pharmacovigilance errors, argues ASBM.

Another of the study's findings: Prescribers would prefer to report adverse events using the product's branded, unique name. Because many generic medications currently on the market do not bother to generate a trade name, this could potentially result in a situation in which branded biologics could be targeted for pharmacovigilance activities based on safety issues that they don't actually cause.

The study also notes that 76% of respondents would infer that a common scientific generic name for a medication would mean that medicines are interchangeable for one another, which is not necessarily the case for biosimilar medications. A further 67% and 64%, respectively, believed the two would be able to be switched both before and during treatment with no change in the result of the treatment.

Study Supports Prior Arguments by ASBM

The comments come in support of ASBM's established positions as laid out in an April 2012 Citizen Petition to FDA. In its petition, ASBM points to the difficulty of conducting pharmacovigilance on a biosimilar medication, and establishes many of the same concerns addressed in its September 2012 study in the abstract.

"It is therefore paramount to differentiate between biologics and biosimilars to facilitate proper pharmacovigilance. This can only be done with distinct nomenclature," wrote ASBM. "Requiring different nonproprietary names for biosimilar and innovator compounds is also the most technically straightforward method to update our pharmacovigilance system."

A subsequent letter to FDA reiterated the group's support for the, "assignment of unique non-proprietary names that stay the same for the life of the product."

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