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Release of FDA Guidance for Biosimilars Pathway Marks Important Step Forward, Says BIO

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BIO President and CEO Jim Greenwood issued the following statement regarding the newly released U.S. Food and Drug Administration (FDA) guidance for the review and approval of biosimilars.</p>

Patient Safety Must Remain Top Priority

Washington, D.C. (February 9, 2012) — Biotechnology Industry Organization (BIO) President and CEO Jim Greenwood issued the following statement regarding the newly released U.S. Food and Drug Administration (FDA) guidance for the review and approval of biosimilars:

“Today the FDA announced specific guidance for the review and approval of biosimilars, medicines that are similar to, but not exact replicas of, innovator biologics.  Biologic therapies save, extend and improve the quality of life for patients living with debilitating diseases including cancer, HIV/AIDS, multiple sclerosis, and a host of rare and orphan diseases. 

“We are pleased that the FDA has developed these important guidances, marking another important step forward on the pathway to biosimilars.  We look forward to reviewing the drafts in detail to ensure that they comply with our key principles, particularly ensuring patient safety, recognizing scientific differences between drugs and biologics, maintaining the physician-patient relationship and preserving incentives for innovation.

“In addition, BIO believes that careful post-market monitoring of the safety of a biologic, whether an innovator or biosimilar, is critical and should be funded by user fees. BIO supports timely authorization of the biosimilars user fee agreement, which will provide FDA with the resources and capacity to evaluate biosimilars products and support biosimilar post-market safety activities, while continuing to prioritize the review of innovative new medicines for unmet medical needs.

“BIO encourages the FDA not to delay approval for new innovator biologics as it undertakes a pathway for approving biosimilars. The needs of patients awaiting innovative cures and therapies for unmet medical needs must remain paramount.

“BIO looks forward to continuing to work with the FDA on finalizing the pathway for biosimilars.”