BIOCAD experts the results to support its product’s approval in other countries as well. It expects some overseas approvals by the end of 2018 or early 2019, it said.
The company completed a Phase 3 international clinical trial of its biosimilar in ankylosing spondylitis (NCT02762812). It terminated the main phase of its Phase 3 global study in rheumatoid arthritis (NCT02762838).
In the trials, BIOCAD compared its biosimilar directly with Remicade. The results showed that the biosimilar antibody had stability, therapeutic activity, and safety equivalent to Remicade, the company said.
Infliximab is an engineered antibody that was developed to block the activity of tumor necrosis factor alpha (TNF-alpha). It is used as a first-line therapy for several autoimmune, inflammatory diseases, including inflammatory bowel disease (IBD), rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis.
Infliximab biosimilars can significantly reduce treatment costs for people with severe autoimmune disorders. Several biosimilar formulations of Remicade have been approved and are available worldwide. They include Remsima, developed by Celltrion, and Ixifi, developed by Pfizer.
BIOCAD said it believes India will be the first country outside Russia to receive shipments of its biosimilar.
Infliximab is the fourth monoclonal antibody biosimilar for which BIOCAD has gained regulatory approval. Past approvals include biosimilars of bevacizumab, trastuzumab, and rituximab.
Dmitry Morozov, BIOCAD’s general director, said the company expects to obtain
European Union marketing authorization for some of its biosimilars in 2021.
The European Union requires clinical trials in its jurisdiction, he pointed out. “Taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021,” he said.