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Infographic
Weight by therapeutic area of new biosimilars
According to the German Association for Biosimilars (AG Pro Biosimilars) there are 300 pending approval studies that may lead to the arrival of new biosimilars.
The number of diseases they are used against is increasing, for example in oncology, immunology, ophthalmology and dermatology, which means decreasing costs and more access for patients. According to their data, 30% are for biosimilars indicated in immunology, 22% in oncology, 17% in ophthalmology, 9% in metabolic diseases and 23% in other diseases.
AG Pro biosimilars
https://probiosimilars.de/grafik-des-monats/april-2022/
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meeting report
WHO informal consultation on the revision of the guidelines for the evaluation of biosimilar products
This document reflects the reflections and agreements of a group of international regulation experts (European Union, China, Japan, USA, Canada, South Korea, Ghana and Argentina) that were consulted by the World Health Organization (WHO) to promote the review of its guidelines on the evaluation of biosimilars adopted in 2009. Some conclusions on aspects of clinical development are worth highlighting. Regarding the need for a phase 3 comparative clinical trial, if sufficient evidence of biosimilarity can be drawn from other parts of the comparability exercise, this was considered inappropriate and the use of an adequately powered efficacy trial was preferred, as that this is terminology often used in regulatory guidance on biosimilars. Another point of great concern was whether the safety data from the limited clinical evaluation will be adequate as the importance of safety, including immunogenicity, should not be underestimated.
Wadhwa, M. et al. April 2022. Biologicals
https://pubmed.ncbi.nlm.nih.gov/35466023/
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Infographics
Biosimilar Case Studies
In a further step after the publication of informative infographics from the US Food and Drug Administration (FDA) on biosimilars, these new materials are intended to illustrate examples that can happen in daily practice.
The “Case Study — Level 1. Foundational Concepts” exemplifies how a recently graduated nurse maintains a dialogue with a rheumatology nurse about biosimilar medicines. Thus, the latter explains the differences between generic and biosimilar, the differences between batches of biological medicines, or the economic advantages for the health system, among other issues.
The “Case Study — Level 2: Regulatory and Scientific Concepts” illustrates how a prescribing physician is faced with the position of prescribing a biosimilar for the first time. To resolve some doubts, he goes to the FDA website and makes use of the resources on biosimilars for this purpose. In addition, the document includes a brief doctor-patient conversation that reflects shared decision-making in which the doctor's trust is key to patient acceptance.
FDA
https://www.fda.gov/media/154918/download
https://www.fda.gov/media/154919/download
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Scientific article
Real-life effectiveness of adalimumab biosimilars in patients with chronic plaque psoriasis
The main objective of this study was to analyze the survival of the drug adalimumab in patients with chronic plaque psoriasis and the factors associated with its discontinuation. The 1-year survival of the drug and the independent factors associated with its discontinuation were analyzed in a total of 410 patients. Adalimumab one-year survival was 81,5% in the overall study population. Obesity was associated with a higher risk of adalimumab discontinuation, while psoriatic arthritis and receiving adalimumab as first systemic treatment were associated with a lower risk. They conclude that the real-life efficacy of biosimilars is consistent with that previously reported for the original. It is expected that the favorable cost-effectiveness profile of biosimilars will not only allow greater access to those for psoriasis, but also redefine the standard of psoriasis. Given rising healthcare costs, starting to treat patients with biosimilars can reduce the cost of treatment while maintaining high-quality care.
Bellinato, F et al. Dermatology and Therapy, April 2022
https://link.springer.com/article/10.1007/s13555-022-00732-y
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Webinar
Gain-sharing: new agreement strategy with biosimilars. SEFH
Webinar organized by the Spanish Society of Hospital Pharmacy (SEFH) within its second edition and moderated by Joaquín Borrás Blasco from the Pharmacy Service of the Hospital de Sagunto, Valencia. It has the participation of Joaquín Rodrigo, president of BioSim and Miguel Ángel Calleja, head of the Pharmacy Service of the Virgen de la Macarena Hospital, Seville.
BioSim's president gave an introduction to the gainsharing concept and a review of international success stories. Lastly, he reported on the advances in the implementation of this type of incentives in the CCAAs.
Dr. Calleja, for his part, valued the efficiency provided by biosimilars in biological therapy and his vision of profit-sharing agreements linked to these medicines from healthcare practice. For example, highlighting the role of the hospital pharmacist in the switch between original and biosimilar medication that is linked to this type of agreement.