1
consultant report
Impact of biosimilar competition in Europe, 2022
The eighth edition of the report 'Impact of biosimilar competition in Europe', commissioned annually by the European Commission, analyzes 23 European markets. The biosimilar competition for the biologic medicines segment is of great relevance as biologics represent 35% of medicine spending in Europe and are growing at 11,3% in the last five years (five points above the total market). Some of the main conclusions of this edition are that the savings derived from competition due to the commercialization of biosimilars has reached an all-time high or that patient access is improving, but with great disparity between countries. It is expected that although patent loss will triple in the next 5 years compared to the previous 5, biosimilars will not be commercialized for all originator medicines.
IQVIA
2
Compendium
Compendium of real-life evidence summaries for biosimilars in Oncology
ASK is a training portal on biosimilars in Oncology, which has a teaching staff made up mainly of hospital and oncology pharmacists. After the biosimilars in oncology manual published about a year ago, ASK launches this compendium of real-life evidence for the use of these drugs in this therapeutic area. Specifically, it includes 6 papers on the use of trastuzumab, rituximab, and bevacizumab in European countries (Denmark, Germany, and Italy) and in the United States, which are retrospective observational studies or surveys. In a very visual way, it explains the characteristics of each study (all of them published between 2020 and 2022), their main findings and limitations.
ASK Biosimilars
3
Scientific article
Assessing the benefits of anti-TNF biosimilar competition in off-patent and on-patent medicines: a southern European review
This article discusses how the entry of biosimilars into the Italian, Portuguese, and Spanish markets has broadened general access to TNF-alpha inhibitor pharmaceuticals. In addition, they have generated savings within the class of TNF-alpha inhibitors even after the increased use of these molecules. However, the potential for the biosimilars infliximab, etanercept, and adalimumab to generate price competition outside of their own drug class appeared limited in the markets studied. Taking into account this limitation and that after the availability of biosimilars of TNF-alpha inhibitors there have been changes towards therapies that are still under patent and at a higher cost, the need for policies that not only seek greater use of biosimilars is highlighted. , but also support a sustainable market for these products. This is expected to encourage the future development of biosimilar medicines.
Barcina Lacosta T, et al. December 2022, Frontiers in Pharmacology
https://www.frontiersin.org/articles/10.3389/fphar.2022.1031910/full
4
Regulatory
WHO Biosimilar Assessment Guidelines
In 2022, WHO has updated its recommendations on the evaluation of biosimilars to provide globally acceptable principles for the licensing of biologics that are claimed to be similar to biologics of assured quality, safety, and efficacy that have been licensed on the basis of a complete license file. On the basis of demonstrated similarity, the authorization of a biosimilar would be based in part on the non-clinical and clinical data generated for an already authorized originator product. These Guidelines can be adopted by National Agencies around the world or used as the basis for establishing national regulatory frameworks for the authorization of such biosimilars. The key updates in the revised guideline from the previous one are a limited and exception-based approach to animal studies, a simplified approach to considering clinical comparability requirements, and a simplified approach to obtaining original product.
April 2022, WHO
https://www.who.int/publications/m/item/guidelines-on-evaluation-of-biosimilars
5
Institutional
What do biosimilar medicines contribute to the National Health System?
In this sixth video advice from the channel on biosimilar medicines, the opportunities that biosimilars offer the National Health System are addressed. Biosimilars are a tool to support sustainability by helping to promote competition in the market, maintaining the same guarantees of quality, safety and efficacy as original medicines. The savings they generate are used for other uses, for example, to treat more patients with biological treatments with the same budget or even to expand the use of biological medicines to treat patients earlier, which translates into better health outcomes.