US biosimilars: Quality trumps manufacturing location, say physicians

By Dan Stanton

- Last updated on GMT

Image: iStock/TACrafts
Image: iStock/TACrafts
American-made biosimilars hold no advantage in the US market according to patient and physician groups which place emphasis on trusted and reputable manufacturers instead.

Where a biologic is made could be a differentiator in the burgeoning US biosimilars market, with patients and physicians favouring domestically-made products, Coherus Biosciences said last month​.

But a poll conducted by this publication found 70% of our readers disagree with the Californian biosimilar developer, believing American-made will not be more successful than foreign-made products in the US. There were 117 respondents.

And an even higher percentage – 75% – believe US physicians and patients do not care where a biologic is made so long as it is safe, as did Brian Kennedy, executive director at the Alliance for Patient Access’s (AfPA) National Physicians Biologics Working Group.

While the issue has not been considered by AfPA – a patient access advocacy group supported by industry group BIO, several Big Biopharma firms and major equipment suppliers​ – he told Biopharma-Reporter the manufacturing location of a biosimilar poses an interesting question but little concern.

AfPA’s expectation would be that regardless of where a biosimilar is manufactured, like any other medicine, if it is marketed and dispensed in the US it will be FDA approved and manufactured in accordance with FDA standards. Accordingly, safety and efficacy should not be a concern.”

Similarly Dennis Cryer, a co-convener for the physician group Biologics Prescribers Collaborative (BPC), told us that while it is customary for pharmaceutical and biotechnology companies to have manufacturing facilities spanning across the globe, “all drugs approved in the US, regardless of where they are made, must be in compliance with the Federal Food, Drug, and Cosmetic Act, which requires that drugs meet manufacturing standards to assure quality and product label requirements.”

Therefore, he continued, “the Collaborative does not believe that ‘American-made’ biosimilars will be more successful in the US.”

Instead he said his group – which represents US physicians who regularly prescribe biologics – place emphasis on “a reputable and trusted manufacturer, known for high-quality and reputable supply.”

He added: “One of the key factors that will impact a successful biosimilar uptake in the US is physician confidence in the product. The data and analytics packages submitted to FDA from companies looking to seek approval for a biosimilar must be robust and extensive to instil physician confidence and encourage the appropriate use of biosimilars.”

Related topics Markets & Regulations Biosimilars

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