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FDA urged to give biosimilar medicines distinct scientific names

Alliance for Safe Biologic Medicines highlights safety concerns if different products have same name

All biosimilar medicines should have their own distinct scientific name in order to avoid safety concerns, says the Alliance for Safe Biologic Medicines (ASBM).

The Alliance is calling for the US Food and Drug Administration (FDA) to implement such a requirement as part of its biosimilar pathway, which offers guidance for companies on how to bring to market a biological product that is similar to an original medicine.

The request follows a survey of physician conducted by the ASBM that found 64 per cent of physicians would assume if products have the same scientific name, a patient can be safely switched from one product to another during treatment.

And more than 76 per cent of the 350 endocrinologists, dermatologists, oncologists, rheumatologists, nephrologists and neurologists surveyed said they view products with the same scientific name as structurally identical.

This has problems for patient safety when it comes to biosmilars, however, said Dr Richard Dolinar, chair of the ASBM, as each product is different from the next.

"[M]aking copies of these highly complex medicines presents significant challenges for physicians and regulators. Biologics are produced from living cells and copies will be only similar, not identical to the original.”

Physicians were found to be knowledgeable about biosimilar products though, and were aware of the concerns of switching drugs during treatment.

According to the survey, 86 per cent of physicians want to be notified before a patient is switched to a biologic, other than the one prescribed, even if there are no known concerns associated with the product.

“This survey clearly indicates that physicians familiar with biologics know minor changes can make a big difference for sick patients,” said Dolinar.

Draft guidance for the FDA's biosimilar pathway was published in February, 2012, although final guidance is still in development.

The FDA has also made progress on the biosimilar front with the introduction of biosimilar user fees as part of its renewal of the FDA Safety and Innovation Act (FDASIA).

17th September 2012

From: Sales, Regulatory



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