Eye on Pharma: Biocad Forges Ahead With Biosimilar Infliximab

Biocad, a Russia-based drug manufacturer, received approval for an infliximab biosimilar (referencing Remicade) from Russia’s Federal Drug Control Service last month. The company anticipates expanding to other markets as soon as later this year, or early 2019.

In order to receive regulatory approval, Biocad completed international clinical studies of the infliximab biosimilar in direct comparison with the reference product. The infliximab biosimilar was investigated in treating indications of its reference, specifically ankylosing spondylitis and rheumatoid arthritis (RA).

The studies found that the therapeutic effects of the biosimilar were shown to be equivalent to the reference. In addition, the safety profiles of the 2 drugs were also similar in the long-term.

Biocad reportedly believes that India will be the first country to receive shipments of the biosimilar, where the infliximab market is valued at around $50 million for 2018.

Infliximab is the fourth monoclonal antibody biosimilar for which Biocad has gained regulatory approval. Past approvals include biosimilars of bevacizumab, trastuzumab, and rituximab. The drug maker won its patent dispute over rituximab with the reference manufacturer, Roche, last October.

Around the same time this legal win was announced, Biocad revealed intentions to enter the European market with oncological and autoimmune therapies. The company has both innovative and biosimilar products currently for sale in Europe, spanning treatments for melanoma; breast, stomach, kidney, and lung cancer; RA; psoriasis; and multiple sclerosis.

“As for the European Union countries, where the approval of biological product goes under centralized procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021,” said Dmitry Morozov, general director of Biocad.

According to a press release, the company estimates that, in 2021, its generics of oncology drugs docetaxel, paclitaxel, pemetrexed, and irinotecan will also enter the European market.