Second Biosimilar Approved

The FDA has approved infliximab-dyyb (Inflectra), which is a biosimilar to Janssen Biotech Inc’s infliximab (Remicade).

Inflectra, which was approved for multiple indications, is administered by intravenous infusion. Inflectra is now the second biosimilar approved by the FDA; the first was Zarxio.

Inflectra may be used for:

· patients aged 6 years and older with moderately to severely active Crohn’s disease who have not responded adequately to other therapies

· adults with moderately to severely active ulcerative colitis who have had inadequate responses to conventional therapy

· patients with moderately to severely active rheumatoid arthritis in combination with methotrexate

· patients with active ankylosing spondylitis

· patients with active psoriatic arthritis

· adult patients with chronic severe plaque psoriasis

“Biosimilars can provide access to important treatment options for patients who need them,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press release. “Patients and the health care community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”

A biosimilar is a biological product that has shown to be extremely similar to an already approved drug. The biosimilar must also show no significant differences in safety or effectiveness.

The FDA’s approval is based on evidence from structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical information.

Inflectra has not been approved as an interchangeable product to Remicade.

The most common adverse effects associated with Inflectra include respiratory infections, such as sinus infection and sore throat; headache, coughing, and stomach pain.

Following infusion, individuals may also experience low or high blood pressure, fever, chills, shortness of breath, rash, itching, and chest pain.

Inflectra also carries a boxed warning about increased risks of serious infections, such as tuberculosis, bacterial sepsis, and invasive fungal infections. The boxed warning also states that lymphoma and other potentially fatal malignancies have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including infliximab products such as Inflectra.

Other potential adverse effects include liver injury, blood problems, lupus-like syndrome, psoriasis, and, in some rare cases, nervous system disorders.

Pharmacists must dispense a medication guide to the patient so he or she knows about Inflectra’s uses and risks.