Biosimilars/Research
Are interchangeable biosimilars at risk?
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].
Comparative efficacy studies: where are we now?
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.
Pertuzumab biosimilar HLX11 meets primary endpoint in phase III comparative clinical study
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.
Uzpruvo/AVT04 biosimilar in profile
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].
Long-term real-world safety experience of biosimilars confirms concept of biosimilarity
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].
Budget impact analysis of Rixathon introduction in Chile for non-Hodgkin lymphoma
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.
Biosimilars in inflammatory bowel disease: are we ready for multiple switches
A review by Teixeira FV et al. discusses whether scientific evidence is sufficient to support multiple switches between biologicals and biosimilars in patients with inflammatory bowel diseases (IBD) [1].
Topline results from clinical development programme for candidate biosimilar AVT05 golimumab
In April and June 2024, Icelandic biosimilar company Alvotech announced promising results from two clinical studies (AVT05-GL-P01, NCT05632211; AVT05-GL-C01, NCT05842213) for AVT05, their candidate golimumab biosimilar. Alvotech is the first company to announce topline results of clinical trials using a proposed biosimilar to Simponi (Janssen Biotech).
Efficacy and safety of the proposed P043 (Zerafil) vs reference omalizumab in allergic asthma
In June 2024, the results of a phase III clinical trial of P043/Zerafil (omalizumab), a proposed biosimilar of Novartis’ Xolair produced by CinnaGen in Iran, showed no significant difference in efficacy and safety parameters to the originator.
Tocilizumab and pembrolizumab biosimilar advances for Korean firms
In June 2024, Celltrion announced promising results from their phase III study for CT-P47, a biosimilar candidate of RoActemra (tocilizumab), in patients with rheumatoid arthritis (RA). Additionally, the company has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the phase III clinical trial of CT-P51, its Keytruda (pembrolizumab) biosimilar. This announcement follows the news that in April 2024, rival Korean biologicals company Samsung Bioepis initiated a phase III clinical trial for SB27, their pembrolizumab biosimilar.
