Remicade Biosimilar Set for US Launch Next Month

Inflectra is the first biosimilar monoclonal antibody approved by the FDA.

Pfizer recently announced that its biosimilar drug, Inflectra, will be available in the United States by the end of November.

Inflectra is a biosimilar of Janssen Biotech’s Remicade, and is the first biosimilar monoclonal antibody to receive FDA approval. It is also the second biosimilar to become available in the United States, according to a press release from Pfizer.

The previous 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.

The biosimilar has been indicated for the treatment of:

  • adult and pediatric patients with moderate-to-severe Crohn’s disease who do not respond to standard treatment
  • adult patients with moderate-to-severe ulcerative colitis who do not respond to standard treatment
  • moderate-to-severe rheumatoid arthritis combined with methotrexate
  • active ankylosing spondylitis
  • active psoriatic arthritis
  • chronic severe plaque psoriasis

The biosimilar has already been introduced into worldwide markets, according to Pfizer. This drug will cost 15% less than the wholesaler acquisition cost of the reference product.

The wholesale acquisition cost for Inflectra will be approximately $946 per vial compared with $1113 per vial for the reference product.

Serious adverse effects include heart failure, reactivation, of hepatitis B virus, liver injury, cancers, and other sometimes fatal conditions. Common adverse effects include respiratory infections, headache, rash, coughing, and stomach pain.

“Biologics have revolutionized the treatment of many life-threatening and chronic diseases. By introducing Inflectra to the US marketplace, Pfizer is helping customers access an additional high quality treatment option that promises greater savings for the healthcare system,” said Diem Nguyen, regional president North America, Pfizer Essential Health Business. “We are proud of our global leadership in biosimilars, and will continue our efforts to advance a sustainable, competitive marketplace for these therapies to deliver a high quality, consistent supply of product and long-term savings and value for patients and physicians.”