European Regulators Back Biosimilar Antibodies

Yael Waknine


June 28, 2013

European regulators are supporting the approval of 2 infliximab biosimilars, according to a news release published today by the European Medicines Agency.

As such, the agency considers Remsima (Celltrion Healthcare Hungary Kft) and Inflectra (Hospira UK, Ltd) to have no meaningful differences from Remicade (Johnson & Johnson) in terms of quality, safety, and efficacy for treating a wide range of indicated autoimmune disorders.

This is notable because antibodies are inherently difficult to replicate and are subject to posttranslational modifications, such as glycosylation. They also may be heterogenous and often include subtle variants. Tight manufacturing controls, conformational structure, and immunogenicity are all hot topics on this point.

Previously approved biosimilars, as reported by Medscape Medical News, have consisted of simpler proteins, such as filgrastim and somatropin.

Product-specific guidelines for the development of monoclonal antibody biosimilars have only been available since December 2012. These include a risk-management plan to confirm long-term safety and efficacy and the detection of any "unexpected rare adverse effects" when the medicine is used in clinical practice.

According to Reuters, Celltrion executive Kim Hyoung-ki told reporters on June 28 that the company plans to seek approval in Japan later this year and that an application with the US Food and Drug Administration is possible in 2015.


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