Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

January 14, 2019
2 min read

Reverse switch from biosimilar to Remicade produces similar IBD outcomes

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Patients with inflammatory bowel disease who switched from biosimilar infliximab to Remicade experienced similar results regarding remission, trough levels and antibody levels, according to research published in Clinical Gastroenterology and Hepatology.

Peter L. Lakatos, MD, DsC, FEBG, AGAF, of the division of gastroenterology at McGill University Health Center in Canada, and colleagues wrote that the practice of switching from an originator biologic to a biosimilar has produced similar outcomes despite some resistance from physicians.

“Physicians may need to also consider reverse switching (switch back to the originator product) or cross-switching, multiple switching among biosimilars in the near future,” they wrote. “Evidence is currently lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars in IBD patients.”

Researchers performed a prospective observational study of patients with IBD who received maintenance therapy with infliximab biosimilar CT-P13 in Hungary (n = 174). In September 2017, patients switched to Remicade (infliximab, Janssen) because of reimbursement policies. Investigators assessed clinical remission — defined as Crohn’s disease activity index less than 150 or no fistulas drainage, or a partial Mayo score of less than 3 for patients with ulcerative colitis — at baseline, weeks 16 and 24. They also tested serum drug levels and anti-drug antibodies at baseline and week 16.

Lakatos and colleagues found no significant difference between clinical remission rates at week 8 before the reverse switch (82.5%, CD; 82.9%, UC), at baseline (80.6%, CD; 81.6%, UC), at week 16 (77.5%, CD; 83.7%, UC) or at week 24 (76.3%, CD; 84.9% UC).

Patients also had similar mean serum trough levels at baseline (5.33±4.7 µg/ml) and at week 16 (5.69±4.94 µg/ml), and researchers found no significant differences in the prevalence of anti-drug antibodies.

Lakatos and colleagues wrote that immunogenicity is one of the primary concerns remaining with biosimilars.

“Biosimilar antibodies are not structurally identical to the originator molecule, raising the concern that substitution in patients whose immune system has developed tolerance to the originator may become sensitized and produce drug neutralizing antibodies,” they wrote. “Results from the present study show no evidence of change in clinical efficacy, safety and immunogenicity after reverse switching from a biosimilar to the originator [infliximab].” - by Alex Young

Disclosures: Lakatos reports he has been a speaker and/or advisory board member for AbbVie, Falk Pharma GmbH, Ferring, Genentech, Janssen, Kyowa Hakko Kirin Pharma, Mitsubishi Tanabe Pharma Corporation, MSD, Pfizer, Roche, Shire and Takeda and had received unrestricted grant support from AbbVie, MSD and Pfizer. Please see the full study for all other authors’ relevant financial disclosures.