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Generics industry pressures FDA over biosimilar naming standards

GPhA says biosimilars should carry same name as branded biologic medicines

Generic Pharmaceutical Association GPHA logo 

All biosimilar products marketed in the US should share the same non-proprietary name as the branded biologic medicines they are copies of, according to the country's generics industry.

Trade body the Generic Pharmaceutical Association (GPhA) has filed a Citizen Petition with the Food and Drug Administration (FDA) which claims that there is no clinically meaningful difference between a branded biologic and its biosimilar that requires a unique name.

“It is simple: biosimilars have no clinically meaningful difference from the reference product, so they should have the same name,” said Ralph Neas, president and CEO of the GPhA.

The regulatory pathway in the US for biosimilars – a copy of a medicine derived from living cells – is still in its infancy, with the FDA last year issuing its first guidance to help the biopharma industry develop these products for market.

However, a lot of questions still need to be addressed, including that of what names these products should go under.

For standard generic medicines – copies of branded drugs made through a chemical process – products need to be sold with the non-proprietary name, or active ingredient.

However, some groups, such as the Alliance for Safe Biologic Medicines (ASBM), have argued that biosimilar medicines should have their own distinct scientific name separate to the branded drug to avoid potential safety problems.

In September last year the ASBM, whose members include Amgen, Genentech and a number of patient and healthcare professional groups, voiced its concerns to the FDA, referencing a survey demonstrating that 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.

At the time, Dr Richard Dolinar, chair of the ASBM, said this was a problem as “biologics are produced from living cells and copies will be only similar, not identical to the original”.

This view is contradicted by the GPhA, which says the US should follow Europe's example where biosimilars have the same scientific name as the branded biologic and there have been no issues with traceability or pharmacovigilance.

“To upset the naming system in place risks engendering confusion and would have a major negative impact throughout the global pharmaceutical supply chain, potentially jeopardising patient access across the globe,” said GPhA CEO Neas.

The GPhA said it continues to encourage a dialogue among FDA and other stakeholders to explore the best way to support the existing system for pharmacovigilance and optimise data collection that ensures patient safety.

Article by
Thomas Meek

20th September 2013

From: Sales, Regulatory

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