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SEO
Statement on the scientific foundations supporting the interchangeability of biosimilar medicines in the EU
On September 19, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued a joint statement confirming that biosimilar medicines approved in the European Union are interchangeable with their reference medicine or with a biosimilar. equivalent. Switching between biologics manufactured and marketed by different companies has become commonplace in clinical practice, demonstrating that EMA-approved biosimilars can be used with the same safety and efficacy in all their approved indications as other biologics. The statement on interchangeability is based on the accumulated experience of 15 years. Approved biosimilars have demonstrated efficacy, safety, and immunogenicity comparable to their reference products. Therefore, no additional systematic switch studies are required to support interchangeability at the prescriber level for the EU-approved biosimilar. Member States will continue to decide whether to allow automatic substitution at the pharmacy level. It is hoped that more patients will have access to biologics.
EMA-HMA
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Scientific article
Biologics and Heart Disease: Challenges and Opportunities
Biological drugs, true protagonists in changing the course of oncological, immunological and genetic diseases, have difficulties entering the cardiovascular area (where small molecules are mainly used) despite the fact that these cardiovascular diseases are the main cause of death in the world. They include the few biological products that have been developed in the cardiovascular field in the last 4 years, which have entered the clinical field or are in the preclinical phase and, therefore, are expected to reach human application soon. These are recombinant proteins (including G-CSF) and mAbs (canakinumab and also rituximab) as well as gene and cell therapy products (in this case the enormous efforts made in the last 20 years, with little success, to develop gene therapies targeting the myocardium).
The specific characteristics of heart disease can present challenges for the application of biologic drugs in the clinical setting, and overcoming these challenges may offer unprecedented opportunities to radically change the drug mix for treating heart disease, with obvious social and social implications. economic. In this sense, in an illustrative figure on the main challenges facing biologics for heart disease and the opportunities to overcome them, the authors point to biosimilars as a solution to the challenge of high costs.
Ciucci, G et al. 2022 Trends in Pharmacological Sciences
https://www.cell.com/trends/pharmacological-sciences/fulltext/S0165-6147(22)00128-6
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Scientific article
Nurses' knowledge and attitudes towards biosimilar medicines as part of evidence-based nursing practice-International pilot study within the project Nurses Guide to Biosimilars version 2.0
Numerous works have already shown that nurses play a key role in the education, administration, pharmacovigilance and management of side effects of biosimilars. The objective of this international cross-sectional study (funded by the Biosimilars: Nursing Guide Version 2.0. project) was to assess the knowledge and attitudes of 866 nurses towards biosimilar medicines in 11 countries. The survey was conducted using a questionnaire published on the website of the European Organization of Specialized Nurses (ESNO). The results showed that nurses with a higher level of education felt more knowledgeable about biosimilars. A third of XNUMXnd degree RNs said biosimilars are used in their workplace, the majority of XNUMXnd degree RNs said they had never heard of biosimilars. In addition, given that in many countries nurses prescribe medications, a greater training effort on biosimilars is necessary. In fact, most would like to participate in training on biosimilars.
Friganovic A, et al. August, 2022 (International Journal of Environmental Research and Public Health)
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9408045/
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Scientific article
Applications of behavioral economics to pharmaceutical policy making: A scoping review with implications for higher-value biologics
Pharmaceutical policies aimed at influencing the behavior of health professionals must take behavioral economics into account, since issues such as social norms, the status quo, the framework, availability, current bias or loss aversion can influence the success of policies based or geared towards profit sharing, prescription fee, electronic prescribing software, patient communication, and health care provider education or information.
This review examined 45 scientific articles analyzing to what extent behavioral concepts have already been applied in the pharmaceutical domain and what evidence exists on their effectiveness, with the aim of formulating future applications and research hypotheses on policy-making for best value biologics. Regarding profit sharing, they take a novel approach by suggesting a possible way to improve prescriber incentives by presenting the incentive as a loss rather than a gain. An often-mentioned example of a tangible incentive is funding for a nurse to guide the switch process to a biosimilar. An alternative design could be that one already (partially) offers this support, but withdraws or reduces it after a certain period if a certain proportion of better value biosimilars or biologics are not prescribed within the hospital.
Vandenplas Y et al. Applied Health Economics and Health Policy
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9379236/
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video tip
How is the quality, safety and efficacy of biosimilar medicines ensured?
Video advice of the series of videos made by the General Council of Colleges of Pharmacists and MedicineTV and promoted by BioSim. In this case, the video focuses on explaining in an understandable way how to ensure the quality, safety and efficacy of biosimilar medicines. These videos focus on what biosimilar medicines are, how they differ from generic medicines, myths and hoaxes about these drugs, their evolution and their contribution to the health system are some of the topics that are addressed in this new channel. This is a health education initiative that has the joint participation of the national committees of Industry, Hospital Pharmacy and the Pharmacy Office of the General Council of Pharmacists.
General Council of Colleges of Pharmacists
https://www.youtube.com/watch?v=BGdniY3loqU&list=PL3n4WGtlmfBhg5630VMpIiFubzczv_11O&index=3