Year 2026
BioSim welcomes the reception of its main proposals in the new Medicines Act, but expresses caution regarding the practical application of dynamic pricing.
BioSim welcomes the inclusion of mandatory prescription by brand name for biologics, the express elimination of biosimilars as substitutable in the legal text and the exemption from the deductions of Royal Decree-Law 8/2010.
However, the employers' association warns of possible inconsistencies in the new Dynamic Pricing System, which seems to be based more on competition in the market of homogeneous groups than on the effective promotion of the biosimilar medicines quota.
The development of biosimilars is expanding and anticipates a new wave of launches.
> Panitumumab, ramucirumab and enfortumab vedotin, all with oncological indications, are being added to BioSim's Horizon Scanning after the development of their first biosimilar candidates began.
> Biosimilars in development continue to focus on oncology – with new developments in precision oncology – and on immune-mediated diseases.
Joint statement from Spanish associations in the pharmaceutical and cosmetics sectors regarding the European Directive on urban wastewater treatment
Aelmhu, Aeseg, Anefp, AseBio, BioSim, Farmaindustria and Stanpa share the environmental objective of the regulations, but we believe that the proposed extended producer responsibility regime violates the polluter pays principle and is contrary to the principles of proportionality and non-discrimination
Read moreThe biosimilars sector extends a hand to the Ministry of Health to advance the Biosimilars Plan
> In the context of the VII National Biosimilars Conference, the president of BioSim highlighted the Pharmaceutical Industry Strategy of the Ministry of Health as a roadmap to move towards a more competitive, resilient and patient-oriented healthcare ecosystem.
BioSim has put forward a proposal aimed at implementing a Biosimilars Plan in Spain that seeks a rapid adoption of these drugs.
Industry representatives meet at the Senate: 20 years of biosimilars, a success story.
The Spanish Senate hosted the VII National Biosimilars Conference, which commemorates the twentieth anniversary of the arrival of biosimilars in Europe.
> Mónica García, Minister of Health, opened the event by highlighting "the success story of biosimilars as a tool for access and equity."
The Navarre Health Service, in collaboration with BioSim, promotes biosimilars training among its healthcare professionals.
The session “Biosimilar medicines: regulatory guarantees, clinical experience and management strategies” was well attended by healthcare professionals from across the region.
> Jon Guajardo, managing director of Osasunbidea, opened the session in which the head of Medicines for Human Use of the Spanish Agency for Medicines and Health Products participated, among others.
Biosimilars could save the NHS up to 22.000 billion euros: semFYC and BioSim promote their training and use in Primary Care
> The training of professionals and value-based prescribing are key to ensuring efficacy, safety and equity in access to biological treatments
The increasing presence of biosimilars in Primary Care reinforces the need for training in this area.
“Nobody imagined anything like this”: Biosimilars celebrate two decades of exceeding expectations
Since the approval of the first biosimilar in 2006, these medicines have exceeded all initial expectations.
The campaign commemorates 20 years of progress that has facilitated and expedited access to biologics for thousands of patients, while freeing up 2.400 billion euros in 2025 alone that can be reinvested in the healthcare system.
Communicating effectively the switching of biological medicines is key to their clinical success
BioSim has presented a practical guide for clinical teams that seeks to strengthen trust and shared decision-making.
Patients, clinicians, and bioethics experts have agreed on the key steps to address the switching of biologic medicines.
Biosimilars will free up more than 2.800 billion euros for the NHS in 2026
The expected savings are equivalent to 10% of the public pharmaceutical bill.
> Immunology is experiencing the greatest impact, with adalimumab leading the way.
The virtuous circle: reinvesting savings from biosimilars to expedite the entry of disruptive innovative medicines.
The European Commission highlights BioSim's 'Horizon Scanning' as a benchmark for monitoring biosimilars in development
The European report 'Capacity building to support the uptake of biosimilars in a multistakeholder approach' indicates that BioSim is the only identified public source that provides detailed data by active ingredient on biosimilars in the pipeline.
The new report from January 2026 incorporates six new active ingredients, including trastuzumab deruxtecan, the first biosimilar candidate of an antibody conjugate.
BioSim launches “Biosimilars in figures – International”, a reference space for comparing data on the use of biosimilars in Europe
BioSim expands its "Biosimilars in figures" section with a new international scope
The new tool allows for comparison of biosimilar adoption in different European healthcare systems since 2020.