Plasma-derived medicines are unique biologic medicines that treat people with plasma protein deficiencies and dysfunctions. These disorders occur in a very small patient population and belong to a group of rare diseases. In the European Union, a disease is considered rare if it affects 1 individual per 2,000.
It always starts with a person’s donation of plasma. The process of making specialized plasma-derived medicines takes 7-12 months from the time of plasma donation until the medicine is ready for use by patients. In contrast, it takes one month to produce a small molecule pharmaceutical medicine.
Plasma-derived medicines are unique. The source material for manufacturing these medicines comes only from human donations. For most of the conditions that plasma-derived medicines treat, patients have no alternative treatment.
Plasma is collected from healthy donors through a process called plasmapheresis which removes only the plasma and returns the remaining blood components to the donor. Therefore, a plasma donation can be made more frequently than a blood donation. Today, PPTA members operate around 160 plasma donation centres in the European Union. After collection, the plasma donation is frozen and shipped to state-of-the-art facilities for manufacture into lifesaving plasma-derived medicines.
Each plasma-derived medicine is unique, due to the pharmacological and manufacturing differences across different brands and to each patient’s unique response to the treatments. As different brands of plasma-derived medicines are not bioequivalent, these therapies are non-interchangeable, sole-source biologics, so it is essential that patients have continued access to their specific therapy. One-size-fits-all policies are not suitable for plasma-derived medicines and endanger patient health.
“[...] Take into account that human normal immunoglobulin therapeutic products differ from one another in terms of production processes, which might have an impact on specifications
and clinical performance.”
“It is important to realize that there is no single immunoglobulin (Ig) product or method of administration that is suitable for all PID patients. [...] All countries and immunodeficiency centres should have access to a wide spectrum of Ig products, to provide optimal treatment for all immunodeficient patients.”
“Although the active ingredient in IVIg — purified immunoglobulin — is the same from brand to brand, there are considerable differences in the manufacturing processes used. This results in individual products that cannot be used interchangeably.”