European Commission approves Inflectra as biosimilar infliximab

The European Commission has approved the first biosimilar monoclonal antibody therapy of infliximab for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis, according to Hospira.

Inflectra is a biosimilar medicinal product to Remicade (infliximab, Janssen Biotech). It is a chimeric human-murine monoclonal antibody that binds to soluble and transmembrane forms of tumor necrosis factor-alpha (TNF-a), but not to lymphotoxin a (TNF-b), according to a press release.

Inflectra is the first monoclonal antibody (mAb) to receive approval through the European Medicines Agency (EMA) biosimilars regulatory agency as an alternative to an existing biologic. Biosimilar mAbs are expected to save €20.4 billion in health care costs in Europe by 2020, according to the release.

“The rigorous scientific review and approval process by the EMA and EC confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade,” Stan Bukofzer, MD, corporate vice president and chief medical officer of Hospira, said in the release.

Inflectra was approved based on results of a phase 3 randomized, double blind trial that met the primary endpoint of being a therapeutic equivalent to Remicade. During the study, 73.4% of patients assigned Inflectra achieved at least 20% improvement (ACR20 response) in rheumatoid arthritis symptoms after 30 weeks, compared with 69.7% of patients treated with Remicade.

Inflectra also showed equivalence to Remicade in safety and tolerability. Viral infection, sinusitis, nausea, abdominal pain, infusion-related reactions and pain were common side effects. Serious infections, including tuberculosis, sepsis and pneumonia, were reported in patients assigned Inflectra with some deaths reported, the release said.

Inflectra will be distributed throughout Europe as early as possible, honoring any relevant patent protection, according to Hospira.

Inflectra is indicated for:

adults with severe and active rheumatoid arthritis in combination with methotrexate for patients who have had inadequate response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate, and patients not previously treated with methotrexate or DMARDs
adults with moderately to severely active Crohn’s disease (CD) who are intolerant to or have not responded to corticosteroid and/or immunosuppressant therapy, as well as treatment of adults with CD and fistulizing who have not responded to conventional therapy
patients aged 6 to 17 years with CD who have not responded to traditional therapy
patients aged 6 to 17 years and adults with moderately to severely active ulcerative colitis who have had inadequate response to conventional therapy
adults with active and progressive psoriatic arthritis who have had inadequate response to previous DMARD therapy
adults with moderate to severe plaque psoriasis who failed to respond to or were intolerant to other therapies
adults with severe, active ankylosing spondylitis who have had inadequate response to conventional therapy