Biosimilars/Research
US vs Germany and Switzerland: US biosimilars market lags with higher prices
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
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].
Investigating cell, tissue and gene therapy products and their regulation
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
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
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?
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
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
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
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.
Recommendations for improving biosimilar regulations in Latin America
The biosimilar regulatory scenario is very diverse and varies widely in the large group of Latin American countries. Authors Teran et al. presented some recommendations for making biosimilar regulations in Latin America more homogeneous and comprehensive [1].
