Nelson Quoted on FDA Guidance for Interchangeable Biosimilars

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Nelson Quoted on FDA Guidance for Interchangeable Biosimilars

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Law360

Partner Kevin Nelson was quoted on the U.S. Food and Drug Administration’s (FDA) latest guidance on the agency’s criteria for approving “interchangeable” biosimilars. Once approved, pharmacies can automatically substitute those biologics in place of more expensive brands, which could expand the drugs’ accessibility and marketability.

Though the new guidance presents a clearer path for interchangeable biosimilar federal approval, every product will still have to find its own way to market.

Kevin said, “Maybe overall there's a more simplistic aspect to it. [But] it's really going to be product dependent and really going to be depending on the type and the amount of data that's provided."

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