Madrid, March 6, 2026.

• BioSim has presented a practical guide for clinical teams that seeks to strengthen trust and shared decision-making.
• Patients, clinicians, and bioethicists have agreed on the key steps to address the sharing of biologic medicines.

The Spanish Association of Biosimilar Medicines, BioSim, held a press breakfast entitled “Understanding Biosimilars: How to Approach Switching with Patients?”, at which a guide support aimed at clinical teams to facilitate therapeutic exchange under normal clinical practice conditions.

The document originated from the work of a focus group that included patient associations and was subsequently reviewed by clinicians representing their respective scientific societies on the BioSim Advisory Board, as well as by the organization's Ethics Committee. The result is a text that reflects broad consensus and incorporates the various perspectives involved in the process of switching between a reference biologic and its biosimilar.

During the welcome address, BioSim's CEO, Encarna Cruz, noted that in a context where biosimilar medicines continue to expand their presence in the National Health System, BioSim considers it essential to "support their use with tools that facilitate implementation based on scientific evidence, transparency, and trust." Thus, Cruz emphasized, "this guide is a document born from actively listening to what patients need when discussing medication during consultations." The positive feedback from clinicians—the guide's intended audience—"demonstrates their agreement with the approach taken, which is based on trust, rigorous information, and respect for shared decision-making."

A practical tool for professionals

Arantxa Vallés, coordinator of the document, began her presentation by emphasizing that “the exchange of information is not only a clinical act, but also a communicative process. Having structured tools helps reduce uncertainties and standardize best practices.” Therefore, the objective of this work—Vallés stressed—is “to offer clear guidance on how to communicate and manage the exchange with patients, reinforcing aspects such as providing understandable information and addressing doubts about efficacy and safety.” The Guide aims to become a reference resource for clinical teams, “promoting a consistent, ethical, and patient-centered approach” to therapeutic exchange processes.

A necessary consensus in a context of increasing use

The meeting included the colloquium “The value of different perspectives in therapeutic exchange”, moderated by Santiago Cervera, CEO of Healthy Numbers, in which the importance of integrating the clinical vision, the patient's experience and ethical reflection was highlighted.

Yamile Zabana, president of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU), has pointed out that "scientific evidence supports the use of biosimilars, but the success of the switch depends largely on how the process is explained and supported to the patient."

For his part, Pedro Rascón, president of the Macula Retina Association, stressed that “for patients, clear information and the possibility of asking questions are fundamental to building trust.”

From an ethical perspective, Javier Sánchez Caro, president of the Bioethics Committee of Castilla-La Mancha and member of the BioSim Ethics Committee, emphasized that “the exchange of information in clinical practice must always integrate the ethical dimension: that is, guaranteeing autonomy and sufficient information.” This guide achieves the “complex balance between the principle of autonomy and that of justice, understood as the responsible and equitable use of healthcare resources to maximize collective benefit without undermining the patient’s freedom of informed decision-making.”

Document download link: http://www.biosim.es/documentos/Guia-Switch-web.pdf