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Plasma-derived medicines are unique

Treatments for patients with rare diseases in Europe

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.

The unique value chain for producing plasma-derived medicines

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 donation & collection

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.

Plasma-derived medicines are not interchangeable

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.