1
Scientific article
Regulatory framework for non-biotechnological biological medicines in Spain
Scientific advances have made it possible to obtain biological medicines obtained by non-biotechnological processes, particularly those that have chondroitin sodium sulfate, sodium enoxaparin and teriparatide as active ingredients. This paper examines the Spanish regulatory framework regarding these drugs. From the study it can be deduced that different authorizations were requested for these active principles: biosimilar, generic and hybrid procedure. Due to the differences between biosimilars and generics, the attribution of such categories to the same drug is inconsistent, so the author recommends a reform of the regulatory framework in Spain, as well as the introduction of a legal concept of biosimilar drug in the Union European.
Noguera Peña A. Cuban Journal of Pharmacy. 2022;55(1):e705
http://www.revfarmacia.sld.cu/index.php/far/article/download/705/459
2
Infographic
KEYPOINTS Profit Sharing Agreements
This infographic, the result of the session for health managers organized by the Consorci de Salut i Social de Catalunya and BioSim and held on March 15, includes the key points of profit-sharing agreements. It includes everything from the definition of this particular type of incentive to the areas in which it can be applied, including the elements required to put this model into practice in the area of health management.
Health and Social Consortium of Catalonia and BioSim
https://www.biosim.es/documentos/ganancias-compartidas-15M-infografiaV2.pdf
3
Scientific article
Biosimilar, it looks alike, but what does it mean?' A qualitative study of Danish patients' perceptions of biosimilars
This work tries to delve into the perception of Danish patients about biosimilar medicines. In the study, 12 participants were interviewed and expressed the need to be adequately informed about the switch to a biosimilar and considered that it is positive to explain the social benefits of the savings from the use of biosimilars for a better understanding of them. According to them, all this would improve the acceptance and trust of patients and the possibility of taking advantage of the full potential that biosimilars provide.
Varma, M et al. March 2022. Basic Clin Pharmacol Toxicol
https://onlinelibrary.wiley.com/doi/epdf/10.1111/bcpt.13719
4
Report
Biosimilars: consumption trends in Italy
The Italian Drug Agency continues its transparency and benchmarking exercise by updating the complete report on the consumption of biosimilars in Italy and its regions. You can check the evolution of consumption in DDD and packaging by active principle and region.
AIFA, April 2022
https://www.aifa.gov.it/documents/20142/878552/1_TrendConsumiBiosimilari_gen2020-nov2021.pdf
5
Press article
Biosimilars in psoriasis: accessibility and safety, above all
The arrival of biologics in the area of dermatology has been an important milestone in the treatment of psoriasis. Thus, this article in Gaceta Médica reflects it where dermatologists specialized in biological therapy (Dr. Puig, head of the Dermatology Service at H. Santa Creu i Sant Pau and Dr. Carrascosa, head of the Dermatology Service at H. Germans Trias i Pujol) argue that the advent of biological drugs has been considered a true revolution in terms of therapeutic expectations. Thus, the advent of biosimilars for various anti-TNFs has modified the accessibility of patients to these treatments. It has been shown that access is faster when they allow two or three patients to start treatment every day in a specialized clinic and there is, according to the specialists, room to improve the training of biosimilars.