Class Biological Medicines

The course unit Biological Medicines is part of the 4th year of the MICF and provides an in¿depth approach to biological medicines, one of the most innovative and expanding areas in drug development. It aims to enable students to understand the scientific, regulatory and clinical framework of these medicines, as well as the opportunities for pharmaceutical intervention in research, industry, hospital and community pharmacy settings. The CU is particularly relevant to prepare future pharmacists for the safe and effective use of biological and biosimilar therapies, supporting evidence¿based pharmacy practice and optimisation of health outcomes.

Not applicable

Introduction to biological medicines: definition, evolution, current therapeutic importance. Differences from synthetic drugs regarding structure, stability, routes of administration, storage, and variability. Production of innovative biologics and biosimilars: cellular platforms, expression, purification, and quality control. Concept of biosimilarity and comparability studies, including extrapolation of indications. Issues of substitution, interchangeability, and implications for prescribing and dispensing. Innate and acquired immunogenicity: mechanisms, risk factors, and clinical impact. Pharmacovigilance: traceability, adverse reaction reporting, risk management plans. Types of biopharmaceuticals: monoclonal antibodies, vaccines, hormones, cytokines, enzymes, blood factors, therapeutic proteins, and advanced therapy medicinal products. Quality, safety, and regulation (EMA). Clinical use across specialties and special populations. Role of the pharmacis.

The CU uses theoretical¿practical case resolution in real or simulated contexts, supervised by clinical pharmacists with expertise in the area, promoting the integration of clinical data, regulatory information and scientific evidence. Digital resources (Moodle platform, regulatory and scientific databases) are used to support autonomous study and classroom activities, including quizzes, forums and guided analysis of technical documents (SmPCs, guidelines). Small¿group work, structured discussion and critical reflection are emphasised as key strategies to develop clinical reasoning and decision¿making skills in biological therapeutics.

European Medicines Agency. (2025). Biological guidelines. EMA. Disponível em: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/biological-guideline Organizaçã¿o Mundial da Saúde. (2025, 12 fevereiro). Biosimilars: expanding access to essential biologic therapies. WHO. Disponível em: https://www.who.int/news/item/13-02-2025-biosimilars--expanding-access-to-essential-biologic-therapies Edwards, C. J., et al. (2017). Dosing down with biologic therapies: A systematic review and practical guidance. Rheumatology, 56(10), 1777-1787. https://doi.org/10.1093/rheumatology/kex534 Fiest, K. M., Brouwer, J., Roberts, D., et al. (2025). Systematic review and meta-analysis of the efficacy and safety of biologic therapies for inflammatory conditions. Thorax. https://doi.org/10.1136/thorax-2025-223014