Regulatory Focus™ > News Articles > Industry Giants Spar Over Substitutability and Interchangeability of Biosimilar Products

Industry Giants Spar Over Substitutability and Interchangeability of Biosimilar Products

Posted 30 January 2013 | By

A famous quote from Shakespeare famously states that, "A rose by any other name would smell as sweet." But if a recent spat covered in The New York Times on the interchangeability of biological products is correct, perhaps Shakespeare got it wrong.

The root of the problem lies in therelation between a biological product and its "generic" competitor, sometimes referred to as a biosimilar, a follow-on biologic, a similar biological product, or subsequent entry biologic.

Some, and in particular the generic pharmaceutical industry, believe that there ought to be a low bar set for biosimilar products to be substitutable or interchangeable for the original biological product.

The branded biologics industry, including companies such as Amgen and Genentech, meanwhile, argue that because subtle differences exist between branded and generic products, a presumption of substitutability should not exist, and manufacturers of biosimilars should be forced to conduct extensive clinical testing to prove sameness.

[For more on interchangeability, please see Regulatory Focus' 28 September explanation, "Biosimilar Interchangeability Problems Pose Complex Challenge for Regulators."]

Enter: The Times

But rather than wait for the debate to be settled in regulatory circles, such as with the US Food and Drug Administration (FDA), branded biologics companies are seeking to pre-empt its actions by creating a firewall of sorts at the state level, The Times reports.

The Times article describes a plethora of activities being conducted on the state level by branded biologics companies which are hoping to-according to the article, at least-ward off competition from biosimilar products by making it more difficult for pharmacies to substitute biosimilar products for a prescribed biologic, sometimes done as part of a pharmacy benefit management (PBM) program.

Two companies in particular-Amgen and Genentech-have worked to write legislation now sponsored in at least eight states imposing these restrictions, which critics say needlessly reduce biosimilar competition and the consumer savings projected to accompany the switches. The price for some generic chemical drugs can be less than 20% of the branded originator, though its effect on biological products is considerably less clear.

At the root of that effort has been entities like the Alliance for Safe Biologic Medicines (ASBM), which has previously argued that its concerns are grounded in regulatory matters. For example: If a biosimilar product is given a generic name-and thus the presumption of substitutability-might the branded and follow-on biologic products be confused in pharmacovigilance reports despite there being minor differences between the two products?

The same group at other times has argued that it's a matter of safety for patients. Physicians, they have said, more completely "understand the complexity of these drugs and the differences between [them]."

The group is supported by-among others-Genentech and Amgen.

A recent press statement by Amgen indicated that the policies would benefit patients by "increasing confidence in the biosimilar pathway."

"It is important to have consistent policies in place at the federal and state level," said Scott Foraker, vice president and general manager of biosimilars at Amgen. The remainder of its statement largely mirrors points made by ASBM, including the need for unique pharmacovigilance measures, the safety issues associated with minor differences, and the deference to doctors rather than insurance companies or pharmacists.

Genentech did not have any statement available at press time.

What's in a Name?

By attempting to separate the concepts of interchangeability, a practical concept concerned with whether products are similar enough to be swapped, and substitutability, a legal concept concerned with whether prescribers have the right to do so, the groups hope to hold off generic competition.

So is a biosimilar the same as an interchangeable biologic? Is a biosimilar a generic? The Generic Pharmaceutical Association (GPhA) argues the distinction exists but-to borrow a phrase-the smell of the rose is just as sweet.

"Biosimilar medicines, which are less costly versions of brand-name biologics, have been used safely in Europe for nearly seven years," the group noted in a recent press statement responding to The Times' story. "While in the guise of supporting biosimilar efforts, Amgen and Genentech are making every effort to limit consumer and patient access to safe and effective biosimilars in the future."

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