US vs Germany and Switzerland: US biosimilars market lags with higher prices

Biosimilars/Research | Posted 27/01/2023

In Germany and Switzerland, more biosimilars were marketed and at lower prices than in the US between 2011 and 2020, finds a JAMA Network Open article [1].

Drug survival of adalimumab biosimilars in psoriasis treatment in Spain

Biosimilars/Research | Posted 20/01/2023

A review by López-Ferrer A et al. entitled ‘Drug survival of adalimumab biosimilars in real-world treatment of psoriasis: A Spanish multicenter study’ provided perspective of the factors associated with biosimilar adalimumab survival in Spain [1].

Pegfilgrastim biosimilars in US supportive oncology

Biosimilars/Research | Posted 13/01/2023

Humphreys et al. published a narrative review article concerning the administration options and the economic considerations of biosimilar pegfilgrastim in supportive cancer treatment in the US to maximize patient benefit[1].

Investigating cell, tissue and gene therapy products and their regulation

Biosimilars/Research | Posted 12/12/2022

Cell, tissue and gene therapy products or (CTGTPs) are often breakthrough therapies with immense potential in treating diseases with no cure or rare diseases with high treatment burdens. However, few of such therapies have been approved and some have been recalled due to safety issues. Now, a study published in GaBI Journal [1] has investigated these therapies and the manufacturing and regulatory challenges they pose.

AVT02 biosimilarity with Humira proved in chronic plaque psoriasis treatment

Biosimilars/Research | Posted 01/12/2022

Results of clinical patient trials of Alvotech’s high concentration formulation biosimilar of adalimumab, AVT02, demonstrate comparable efficacy, safety and immunogenicity to the reference product Humira, according to a study published in Biodrugs [1].

Investigating biosimilar product drift and divergence

Biosimilars/Research | Posted 25/11/2022

Following the establishment of biosimilarity, there are no regulations that require manufacturers to perform quality or clinical studies to compare biosimilar versus originator products post-approval. In an investigation published in GaBI Journal [1], Dr Pablo Matar examined the concept of biosimilar manufacturing ‘drift’ and product divergence [2].

Biosimilars, are they comparable to their reference counterparts?

Biosimilars/Research | Posted 18/11/2022

Biologicals such as rituximab and trastuzumab have improved treatment outcomes for many cancers. However, due to their high economic burden, ‘highly similar’ products known as biosimilars have been developed and used. Yet, there is still concern surrounding comparability of efficacy and safety between the biosimilar and its reference biological, especially regarding patients switching from the reference to the biosimilar.

The cost savings of non-medical switching in dermatology

Biosimilars/Research | Posted 04/11/2022

Non-medical switching is when a patients' therapy is changed due to reasons not linked to their health and can involve non-interchangeable drugs, potentially affecting the treatment outcomes.

Switching from adalimumab originator and ABP501 to SB5 in arthritis patients

Biosimilars/Research | Posted 28/10/2022

The introduction and availability of biosimilars entails a considerable increase in the patient access as well as a decrease in the patient cost. Thus, biosimilars could be the answer to the economic impact of the reference biological.

Updates for European Pharmacopoeia monographs for biotherapeutic products

Biosimilars/Research | Posted 21/10/2022

The European Pharmacopoeia produces monographs for biotherapeutic products that are publicly available and considered the standard for defining the quality of these medicines. A recent study published in GaBI Journal [1] examines whether the challenges posed by complex products such as the introduction of biosimilars, have been met by new elements that have been added to the monographs.