News

Biosimilar infliximab gains FDA Advisory Committee endorsement


 

References

CT-P13 has the potential to make a fairly widely used biologic significantly more affordable. In countries where it has come onto the market, it’s been priced at roughly 30% below the prevailing cost of Remicade prior to this competition.

“Infliximab is an extremely important tool in our armamentarium for treatment of both ulcerative colitis and Crohn’s disease,” commented Dr. Stephen B. Hanauer, professor of gastroenterology and hepatology at Northwestern University in Chicago. “Biologic therapies account for an increasing proportion of health care costs for chronic diseases such as inflammatory bowel disease and reducing these costs will be important as increasing numbers of patients are benefiting from long-term biologic therapies. Having reviewed the extensive preclinical and clinical data with CT-P13, I am comfortable with potential substitution or switching as long as physicians are aware of the change and can track any potential reactions to the administered product,” he said in an interview.

“Infliximab is currently used by U.S. rheumatologists to treat certain patients with rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis. It is not the most-widely used tumor necrosis factor inhibitor, which is adalimumab, but it is often used. After FDA approval, biosimilar infliximab is anticipated to be priced lower than Remicade and that would likely increase use of infliximab for rheumatologic conditions,” said Dr. Jonathan Kay, a rheumatologist and professor of medicine at the University of Massachusetts in Worcester. “The clinical experience with CT-P13 in trials and in routine use in other countries show no significant loss of efficacy or any other major problem when changing patients from Remicade to CT-P13. All the data suggest that CT-P13 is highly similar to the reference product. It’s almost akin to comparing one lot of Remicade to another lot of Remicade. I personally would not have a problem initiating a patient on CT-P13 if infliximab was the appropriate drug to use,” Dr. Kay said in an interview.

Dr. Hanauer has been a consultant to Celltrion. Dr. Kay has been a consultant to several drug companies.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

Pages

Recommended Reading

VIDEO: EULAR updates cardiovascular-disease risk recommendations
Psoriatic Arthritis ICYMI
EULAR: Panel targets six rheumatic disease comorbidities
Psoriatic Arthritis ICYMI
Methotrexate ups risk of liver abnormalities, but not serious hepatic events
Psoriatic Arthritis ICYMI
Shingles vaccine protection lasted 5-6 years in autoimmune disease patients
Psoriatic Arthritis ICYMI
Stroke risk rose in autoimmune disease patients after herpes zoster
Psoriatic Arthritis ICYMI
State laws, regulatory concerns complicate biosimilars landscape
Psoriatic Arthritis ICYMI
Steroid use down, biologic use rising in pregnancies of women with rheumatic disease
Psoriatic Arthritis ICYMI
ACR: Etanercept during pregnancy doubles the odds of major malformations
Psoriatic Arthritis ICYMI
Biologic treatment in pregnancy requires balancing risks
Psoriatic Arthritis ICYMI
Step therapy and biologics: An easier road ahead?
Psoriatic Arthritis ICYMI