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Biosimilars/Research

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How the WHO is expanding access to biosimilars

Biosimilars/Research | Posted 11/04/2025

The World Health Organization (WHO) has highlighted its role in expanding global access to biosimilars in a February 2025 feature article, ‘Biosimilars: expanding access to essential biologic therapies’ [1].

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Optimizing costs with biosimilars: Brazil's case

Biosimilars/Research | Posted 21/03/2025

The adoption of biosimilars, biological drugs similar to reference medications, has emerged as a pivotal strategy for reducing healthcare costs while maintaining efficacy and safety. A review by Azevedo, VF, et al.examines how Unimed Maringá, a private healthcare provider in Brazil, implemented a biosimilar management programme, achieving significant cost savings and broader patient access to essential therapies [1].

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Biosimilars in low- and middle-income countries

Biosimilars/Research | Posted 05/03/2025

Biosimilars offer a viable route to treatment for those with non-communicable diseases (NCDs) living in low- and middle-income countries (LMICs). A review article published in GaBI Journal titled ‘Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries,’ offers insights into the benefits of biosimilars for better access to biologics in LMICs, focusing on data from selected emerging markets (Brazil, Colombia, Malaysia, Mexico, Nigeria, Taiwan, and Turkey).

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Positive safety and efficacy primary endpoint results for AVT05 (golimumab proposed biosimilar)

Biosimilars/Research | Posted 28/01/2025

In November 2024, at the American College of Rheumatology (ACR) Convergence 2024, Alvotech shared the positive results of the primary endpoint of their comparable safety and efficacy study for their golimumab proposed biosimilar, AVT05 [1]. This is a biosimilar candidate to Janssen Biotech’s anti-inflammatory drug product, Simponi.

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Are interchangeable biosimilars at risk?

Biosimilars/Research | Posted 21/01/2025

In the US, the interchangeability designation earned by some biosimilars, now allows them to be substituted at pharmacy level, without physician approval. This has bolstered patient and physician confidence in these products, boosting their uptake. However, study published in GaBI Journal now examines how misinformation about interchangeable biosimilars undermines US health policy, physician confidence, and patient health [1].

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Comparative efficacy studies: where are we now?

Biosimilars/Research | Posted 08/01/2025

In an article published in GaBI Journal titled ‘Comparative efficacy studies of biosimilars: data versus theoretical risks, beliefs, and comfort’ [1], Professor Pekka Kurki, a Clinical Immunology Professor at University of Helsinki, Finland and a member of the Finnish Medicines Agency (Fimea), explores the current position on biosimilar efficacy studies held by medicines agencies across the globe.

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Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study

Biosimilars/Research | Posted 03/12/2024

Shanghai Henlius Biotech and Organon announced on 30 September 2024 that their phase III comparative clinical trial for HLX11, an investigational biosimilar to Perjeta (pertuzumab), met its primary endpoint. 

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Uzpruvo/AVT04 biosimilar in profile

Biosimilars/Research | Posted 26/11/2024

Alvotech and STADA’s Uzpruvo/AVT04 is an ustekinumab biosimilar with similar efficacy, tolerability, safety and physicochemical and biological characteristics to Stelara, the reference product, as has been summarized in a recent study published in Clinical Drug Investigation [1].

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Long-term real-world safety experience of biosimilars confirms concept of biosimilarity

Biosimilars/Research | Posted 24/09/2024

A review by Sagi S, et al. highlighted that biological medicines are well established in clinical practice for the treatment of many serious and chronic conditions [1]. 

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Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma

Biosimilars/Research | Posted 04/09/2024

Non-Hodgkin lymphoma (NHL) is a significant global health concern, with diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) being the most prevalent subtypes. In Chile, treatment for DLBCL and FL is covered by the public healthcare system, primarily using rituximab-based therapies. The recent introduction of rituximab biosimilars, such as Rixathon, presents a potential for cost savings in the healthcare system.