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Plasma Protein Therapies Not Suitable for Biosimilars
Date:11/12/2010

prohibit the manufacturer from submitting an abbreviated application, as it must instead satisfy the agency's safety and efficacy requirements for a new product.

Plasma protein therapies are complex, large molecule biological therapies that replace missing or deficient proteins in an individual's blood. Each therapy has a specific, multi-step manufacturing process that defines the product. For plasma protein therapies, no range of structural differences between a proposed biosimilar product and its reference product is consistent with the "highly similar" standard that is required for an application for a biosimilar. Even small differences in manufacturing methods can produce changes in the final product that can interact with patients and are impossible to detect without data from human clinical trials.

Most therapeutic classes of plasma protein therapies include multiple brands, yet none of the brands in any class are interchangeable. Because each brand in a class of plasma protein therapies is a unique therapy that is often part of a lifelong treatment regimen in patients with serious, chronic disorders, there is a significant risk associated with alternating or switching brands.  "It is well understood that changing brands of plasma protein therapies in a given therapeutic class puts patients at increased risk for adverse events and other complications including the body's rejection of the replacement protein through an immune system response," said Mary Gustafson, Vice President, Global Regulatory Policy, PPTA.  

The new law provides FDA with the authority to deem a biosimilar as interchangeable with its reference product, meaning it can be substituted for the innovator product without consultation with the prescribing physician or the patient, if it meets a certain threshold.  Since existing brands of plasma protein therapies fail to qualify as interchangeable, an innovator plasma protein therapy should never be considered
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SOURCE Plasma Protein Therapeutics Association (PPTA)
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