Credit: NPG

The European Medicines Agency (EMA) recommended the granting of marketing authorizations for two biosimilar versions of the blockbuster monoclonal antibody (mAb) infliximab (Remicade; Johnson & Johnson).

The lowdown: In recent years, regulatory frameworks in Europe, the United States and elsewhere have been established for the approval of biosimilars (or follow-on versions) of biologics. Biosimilars present much greater regulatory challenges than generic versions of small-molecule drugs owing to their structural complexity. Consequently, biosimilars approved in major markets so far have been peptides and relatively simple proteins, rather than highly complex products such as mAbs. The recommendation of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to approve two biosimilar versions of a mAb therapy is therefore an important indicator of the feasibility of developing such products.

In order for a biosimilar to be approved in Europe, applicants need to show that its quality, safety and efficacy profile does not differ meaningfully from the pioneer biologic, and are required to implement a pharmacovigilance plan. Two biosimilar versions of infliximab, a mAb that is specific for tumour necrosis factor, were evaluated by the CHMP: Remsima (developed by Celltrion) and Inflectra (developed by Hospira). The recommendation for marketing authorization in Europe is for the same indications as Remicade, which include rheumatoid arthritis, Crohn's disease and psoriasis.

The immediate implications for future sales of Remicade (which were more than $US6 billion in 2012) of the EMA's recommendation are unclear, given the uncertainty over the extent of patent protection for Remicade in some European countries.