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The Immune Deficiency Foundation (IDF) advocates that patients have access to safe and effective biologic and biosimilar medicines. The Food and Drug Administration (FDA) is authorized to approve biosimilar medicines, or biosimilars, to assure they are effective and safe. For those in the primary immunodeficiency (PI) community who have antibody deficiencies, the infusion of safe and effective biologic medicines, like immunoglobulin (Ig) replacement therapy, has been lifesaving.

Biologics are medicines made from living organisms and are far more complex and much more difficult to develop and manufacture than other drugs. Biosimilars are medicines that are highly similar but not identical to biological medicines. Because of the uniqueness and complexity of biologics, biosimilars are not generic copies of biologic medicines. While there are a small number of biosimilars approved in other countries, there are no approved biosimilars in the U.S. There are, however, some applications currently under review and others being developed.

Recommendations

IDF recommends the FDA take the following actions as it finalizes its standards for oversight and approval of biosimilar medicines to ensure patient safety:

  • Require biosimilars to prove they are just as safe and effective as reference innovative biologic products.
  • Recognize that there are variations in the complexity of biologics and substantial differences in therapeutic responses to biologics from patient to patient, and therefore standards for the review and approval should not provide for a one-size-fits-all approach.
  • Require that manufacturers of both innovator biologics and biosimilars conduct rigorous clinical testing to demonstrate safety and effectiveness in every condition and distinct patient population for which it is approved for use.
  • Require strict standards for determining whether a biosimilar is interchangeable and can be expected to produce the same clinical result as the reference product in any given patient.
  • Prohibit any automatic substitution of biosimilars for biologics. The choice of products should be determined by a physician in consultation with his or her patient, not by a pharmacist, regulator, or insurer.
  • Ensure that each biologic, including biosimilars, have a distinguishable non-proprietary name. Given the variety of biologics and biosimilars, this will facilitate an expeditious process of determining the cause of an adverse event.
  • Implement a system for accurate tracking of adverse events for all biologics, including biosimilars to promptly and accurately identify safety concerns.

Plasma Safety

IDF advocates to ensure that the plasma supply is adequate and safe to be used in the production of lifesaving therapies including immunoglobulin (Ig) replacement therapy. As a member of the American Plasma Users Coalition (APLUS), a coalition of patient organizations created to address the unique needs of patients that use lifesaving plasma protein therapies, IDF is able jointly work to ensure that the patient voice is heard when relevant public policies, regulations and guidelines affecting access to safe and effective treatment are considered. Together, the coalition represents more than 125,000 Americans living with chronic disorders dependent upon plasma protein therapies for their daily lives. A-PLUS members work together leveraging their resources to monitor and advocate on behalf of all people who rely on plasma-based therapies in healthcare reform and other federal health policy issues.