Biosimilars and biopharmaceuticals: the ERA-EDTA position

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In a position paper by the European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) Council in Nephrology Dialysis Transplantation written by Adrian Covic of the Parhon University Hospital in Iasi, Romania – who received financial gratitude for congress participation, lectures and clinical trials from: Amgen, Affimax, F. Hoffmann-La Roche and Janssen-Cilag – and co-authors, it is stated that biosimilars may offer considerable advantages to hard-pressed healthcare economies, as the costs of providing effective therapies in a variety of new and existing disease areas increase progressively. However, a decision to permit their use clinically should be balanced by a clear mandate to ensure as with all biopharmaceutical agents, that patients, physicians and pharmacists truly understand the complex arguments and decisions which apply to this new and challenging area. In particular, pharmacovigilance is a responsibility that is shared between the pharmaceutical industry, pharmacists and physicians, with appropriately informed and educated patients. Ease of tracing and identification of new/substituted agents especially when dealing with patients who may be exposed to injected therapies for many years is a pivotal requirement and one where new input into nomenclature decisions and systems is now urgently needed. Any decision to employ biosimilar biopharmaceuticals should be taken with appropriate knowledge and understanding of this complex area by the primary responsible physician, after a careful appraisal of the advantages and disadvantages of taking this course of action, and with appropriate systems for pharmacovigilance in place.

According to them, the two chief issues with biosimilar agents include variable potency/response and immunogenicity, which are thought to be due to glycosylation, contamination and changes to 3D structure, but may also be due to the manufacturing process, modified side chains (carbamylation, GSH-adducts), other post-translational processing (methylation, acetylation) and the tertiary and quaternary structures of the protein product.

Concerns remain about comparability demonstrations and ensuring that pharmacovigilance programmes attain uniform excellence across Europe and apply to all new/biopharmaceutical products; that physicians, pharmacists and patients are clearly informed about the benefits, responsibilities for users and potential safety and efficacy issues around the use of any biosimilar agent (with special reference to pharmacovigilance) and that, to improve pharmacovigilance, the substitution of an existing established biological by a biosimilar agent should only be decided by the physician after receiving the informed consent from the patient. Given the difficulties with equivalence of biosimilar products, automatic substitution for biosimilars may have clinical consequences and affect pharmacovigilance efforts. It may be better to forbid automatic substitution for biosimilars and have different International Non-proprietary Names for them, as recommended by the European Biopharmaceutical Enterprises and European Federation of Pharmaceutical Industries and associations.

Source: Nephrol Dial Transplant. 2008;23:3053-5.

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