Biosimilars/Research
Establishing mAb biosimilarity before reaching the clinic
Confirming the biosimilarity of monoclonal antibodies (mAbs) is fraught with challenges beyond those faced by currently approved biosimilars, warn Ebbers and co-authors at Utrecht University, The Netherlands [1]. The threat of unexpected immunogenicity has been well reported, but the problems do not start there. The first steps towards establishing the biosimilarity of an anticancer mAb, the preclinical stage, presents challenges of its own.
Challenges and opportunities for anticancer mAbs
Several best-selling monocloncal antibodies (mAbs) are due to lose patent protection; presenting regulatory authorities with a complex set of challenges as they prepare for the arrival of novel biosimilars, note Ebbers and co-authors at Utrecht University, The Netherlands [1].
Phase III QoL assessments show comparability of biosimilar infliximab
The results of phase III quality of life (QoL) assessments of a candidate biosimilar infliximab (CT-P13) have shown the comparability of the biosimilar (CT-P13) and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).
Phase I study shows equivalence of biosimilar rituximab and MabThera
The results of a randomized, controlled, multicentre, two-arm, parallel-group, double-blind study of CT-P10 (rituximab) in patients with rheumatoid arthritis has shown the equivalence, with respect to pharmacokinetics, efficacy and safety, of the biosimilar (CT-P10) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).
Non-clinical and phase I clinical assessments show similarity of biosimilar rituximab
The results of non-clinical and phase I clinical assessments of a candidate biosimilar rituximab (PF-05280586) have shown similarity, with respect to in vivo, functional characteristics and pharmacokinetic and pharmacodynamic properties, of the biosimilar (PF-05280586) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).
Open-label studies show similarity of biosimilar infliximab and Remicade
The results of two open-label extension studies of Inflectra (CT-P13; infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, have confirmed the similarity, with respect to efficacy and safety, of the biosimilar infliximab and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).
Etanercept biosimilar has comparable pharmacokinetics to Enbrel
An etanercept biosimilar (CHS-0214) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.
Use of similar biotherapeutic products to treat rheumatoid arthritis in Latin America
Latin America has a significantly lower gross domestic product (GDP) compared to Canada, Europe and the US. Despite this fact, the cost of biologicals is in general very similar to countries with higher GDP, causing problems for patients to gain access to these medications. This problem could possibly be solved by the introduction of lower-cost biosimilars to the region.
Clinical trials for follow-on biological products in Brazil
Unlike for generic drugs, authorizing biosimilars without conducting quality clinical trials represents a real threat to patients, according to Professor Valderílio Feijó Azevedo, Professor of Rheumatology at the Universidade Federal do Paraná in Brazil [1].
Extrapolation of biosimilar infliximab indications to inflammatory bowel disease
Gastroenterologists are wary of using biosimilars of infliximab in the treatment of inflammatory bowel disease. This fact is being evidenced by the publication of position statements from various professional groups.
