A biosimilar is a copy version of an approved original biological medicine whose data protection has expired.
Dr Peyrin-Biroulet and colleagues from France provided an overview of the development of biosimilars worldwide.
The research team performed a literature review of manufacturing processes of biosimilars, differences and similarities between biosimilars and the reference product, approval pathways for biosimilars, challenges in clinical trial study design, and of available data from clinical trials.
Biosimilars have the same amino acid sequence and highly similar glycosylation patterns that overlap with the originator product.
|2 monoclonal antibodies have been shown to be equivalent to infliximab in efficacy|
|Alimentary Pharmacology & Therapeutics|
Both efficacy and toxicity are difficult to predict due to subtle molecular changes that might have profound effects on clinical efficacy, safety and immunogenicity.
The team report that their main advantage is related to cost savings. Direct evidence of safety and benefit from clinical trials, post-marketing pharmacoviligance and unequivocal identification of the product as a biosimilar are requirements before approval.
Non-inferiority or equivalence trials are required by regulatory agencies.
Over the past years, the researchers observed that several biosimilars have been approved such as erythropoietin or growth factors.
Recently, 2 monoclonal antibodies, Remsima and Inflectra, have been shown to be equivalent to infliximab (INX) in safety and efficacy in rheumatologic conditions.
Interchangeability, automatic substitution and switching are key issues when treating patients with biosimilars in clinical practice.
Dr Peyrin-Biroulet's team concludes, "Biosimilars represent a new generation of drugs in liver and gastrointestinal diseases."
"In 2013, Hospira's Inflectra (INX) was the first biosimilar monoclonal antibody to receive positive opinion from European Medicines Agency's Committee for Medicinal Products for Human Use for rheumatoid arthritis, inflammatory bowel disease and plaque psoriasis."