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NHF Comments on Biosimilars Approval Process

On December 31, 2010, the National Hemophilia Foundation sent a letter to the U.S. Food and Drug Administration (FDA) urging it not to take shortcuts in approving biosimilar plasma protein therapies.  Clotting factor and other plasma protein therapies are categorized by the FDA as "biological" products, because they are made from organic sources, such as plasma, rather than chemicals.  The FDA is developing a regulatory process for the approval of follow-on biological products, or "biosimilars."  Much the way generic drugs can be taken instead of their brand name counterparts, biosimilars could be used instead of their brand name equivalent.  The proposed new approval pathway would allow biosimilar makers to skip several steps, such as clinical trials, in order to speed these products to the market.

Concerned that an abbreviated approval pathway could pose a safety risk to patients, NHF submitted comments to the FDA urging that plasma protein therapies be excluded from the less rigorous process.  While NHF is aware of the need to create a new regulatory pathway for biosimilars, it wrote that this pathway should not short cut safety standards.  

Follow-on biologics are not identical. The complexity of large molecule biological therapies and the intricacies of the manufacturing process prevent exact replication of the product.  Even minute changes could have dramatic consequences for the patient. 

NHF argued that the FDA must provide assurance that the safety and efficacy of biosimilars have not been compromised.  Until a framework is established guaranteeing the safety and quality of biosimilars, the letter urged that follow-on plasma protein therapies, which include hemophilia factor therapies, be excluded from any abbreviated pathway. 

Read the letter.

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