You are here

FDA Approves Biosimilar Remicade

Renflexis gets the nod for all Remicade indications

The FDA has cleared Renflexis (infliximab-abda, Samsung Bioepis/Merck), a biosimilar product referencing Remicade (infliximab, Janssen), across all eligible indications. The product will be marketed in the United States by Merck.

Renflexis, a tumor necrosis factor (TNF) blocker, has the following indications:

  • Crohn’s disease in adults: For reducing signs and symptoms and for inducing and maintaining clinical remission in adults with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. It is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and for maintaining fistula closure in adults with fistulizing Crohn’s disease.
  • Pediatric Crohn’s disease: For reducing signs and symptoms and for inducing and maintaining clinical remission in pediatric patients six years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy.
  • Ulcerative colitis: For reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adults with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.
  • Rheumatoid arthritis: In combination with methotrexate, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.
  • Ankylosing spondylitis: For reducing signs and symptoms in patients with active ankylosing spondylitis.
  • Psoriatic arthritis: For reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.
  • Plaque psoriasis: For the treatment of adults with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

Patients treated with infliximab products are at increased risk of developing serious infections that may lead to hospitalization or death. Clinicians should carefully consider the risks and benefits of treatment with Renflexis before initiating therapy in patients with chronic or recurrent infections.

Lymphoma and other malignancies, some fatal, have been reported in children and adolescents treated with TNF blockers, including infliximab products. Melanoma and Merkel cell carcinoma have also been reported in patients receiving TNF-blocker therapy, including infliximab products.

 Source: Samsung Bioepis; April 24, 2017.

Recent Headlines

Drug resistance in HIV patients has nearly tripled since 2001
New drug addresses bacterial resistance to standard therapy
Hovering flights lower packages by cable and winch
Ziextenzo helps lower the incidence of febrile neutropenia
The answer may offer a potential treatment for the disease
Drug resistance in HIV patients has nearly tripled since 2001
The number of those with an annual drug spend of $250K or more has increased by 60%
Grading manufacturers would give high-quality, reliable makers a boost, says federal panel
Sharpless is heading back to NCI