- The European Medicines Agency (EMA) approved Hospira/Celltrion's Inflectra, which is a bisomilar version of Johnson & Johnson's blockbuster Remicade (infliximab), last year. The drug was approved for the same indications as Remicade, including Crohn's disease, ulcerative colitis, rheumatoid arthritis, and other inflammatory conditions.
- Inflectra was the first biosimilar monoclonal antibody approved in Europe.
- But physicians still remain skeptical of Inflectra's various extrapolated indications—i.e., a biosimilar may be approved in multiple indications, even if the manufacturer only conducted trials in one or two of those indications.
Approval of biosimilar antibodies is categorically different from approval of biosimilar small molecules, because biosimilar antibody-based drugs are never identical to the original drugs due to their complex structure and manufacturing processes.
Hospira's approach to marketing since Inflectra's approval in 2013 has been to conduct educational forums for physicians, pharmacists, and payers, while focusing on price advantages. Not surprisingly, J&J has countered by emphasizing its long post-marketing surveillance record and well-established safety and efficacy profile.
The educational campaigns have started slowly to budge the market, with physicians in eligible markets—Inflectra is currently only available in central and eastern European countries thanks J&J's patents—beginning to prescribe Inflectra to new patients while resisting switching patients who are already being treated with Remicade over to the biosimilar.