Second US Biosimilar Approved by FDA

The FDA on Tuesday announced the approval of the biosimilar infliximab-dyyb (Inflectra) for multiple indications across a range of autoimmune diseases.

Inflectra the second biosimilar to be approved in the United States and is administered by intravenous infusion.

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

Several patients with varying diseases can be treated with Inflectra, which includes: adults and pediatric patients (6-years-old and up) with moderate-to-severe active Crohn’s disease and adults with severe ulcerative colitis who had an inadequate response to conventional therapy; those with moderate-to-severe active rheumatoid arthritis in combination with methotrexate; those who have ankylosing spondylitis; those with active psoriatic arthritis; and adults with chronic severe plaque psoriasis.

The approval was based on evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and efficacy data to prove that Inflectra is biosimilar to Remicade.

“Inflectra’s approval comes more than a year after the first biosimilar was approved in the US,” said David Lassen, chief clinical officer for Prime. “If approvals continue to be this slow, it will be many years for biosimilars to have an impact on high drug prices. Americans can’t afford to wait and more needs to be done to slow the unsustainable growth in drug costs.”

The most common adverse events were respiratory infections, sore throat, headache, stomach pain, and coughing. Serious adverse events include blood issues, lupus-like syndrome, liver injury, psoriasis, and in rare cases nervous system disorders.

The first biosimilar ever approved in the United States, filgrastim-sndz (Zarxio), became available in September 2015 following its initial approval on March 6, 2015. Zarxio, manufactured by Sandoz, Inc, is biosimilar to Amgen Inc’s Neupogen (filgrastim), which was originally approved in 1991.

A recent report by Express Scripts estimates more than $45 million was likely wasted for every month Zarxio was delayed from hitting the market.

“Biosimilars will do for the biotech market, primarily made up of very expensive injectable drugs, what generic drugs did for traditional oral solid pills a decade ago: lower the cost for safe, effective treatments that improve and save lives,” Express Scripts wrote in the report. “They will revolutionize the category of spending that is among the fastest-growing and most worrisome for payers who want to continue providing sustainable, high-quality benefits for their members.”