Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

Disclosures: Hanauer reports consulting fees from AbbVie, Allergan, Amgen, Arena, Boehringer, Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Genentech, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Progenity, Prometheus, Protangonist, Receptos, Salix, Samsung Bioepis, Seres Therapeutics, Takeda, UCB and VHsquared; clinical research for AbbVie, Allergan, Amgen, Celgene, Genentech, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, Pfizer, Prometheus, Receptos, Seres Therapeutics, Takeda and UCB; speaking fees from AbbVie, Janssen, Pfizer and Takeda; and DSMB from Arena, Boehringer Ingelheim, Bristol Myers Squibb and Protangonist.
August 19, 2021
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Adalimumab biosimilar is safe, effective in patients with Crohn’s

Disclosures: Hanauer reports consulting fees from AbbVie, Allergan, Amgen, Arena, Boehringer, Ingelheim, Bristol Myers Squibb, Celgene, Celltrion, Genentech, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Merck, Novartis, Pfizer, Progenity, Prometheus, Protangonist, Receptos, Salix, Samsung Bioepis, Seres Therapeutics, Takeda, UCB and VHsquared; clinical research for AbbVie, Allergan, Amgen, Celgene, Genentech, Gilead, GlaxoSmithKline, Janssen, Eli Lilly, Novartis, Pfizer, Prometheus, Receptos, Seres Therapeutics, Takeda and UCB; speaking fees from AbbVie, Janssen, Pfizer and Takeda; and DSMB from Arena, Boehringer Ingelheim, Bristol Myers Squibb and Protangonist.
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Adalimumab biosimilar BI 695501 demonstrated similar safety and efficacy compared with adalimumab reference product among patients with Crohn’s disease, according to research published in the Lancet Gastroenterology and Hepatology.

“Biologics that target TNF, such as the monoclonal antibodies infliximab and adalimumab, have had a major impact on the management of CD, greatly improving treatment outcomes,” Stephen Hanauer, MD, Feinberg School of Medicine at Northwestern University, and colleagues wrote. “However, anti-TNF monoclonal antibodies are complex molecules and, for reasons such as high development and marketing costs, patients’ access to them can be limited. Biosimilars have the potential to increase the number of patients able to benefit from biologics, primarily by decreasing treatment costs.”

Clinical response

In a phase 3, randomized, double-blind study, researchers compared the safety and efficacy of biosimilar BI 695501 with an adalimumab reference product among 147 patients aged 18 years to 80 years with moderate to severe CD. Patients received either BI 695501 (74) or adalimumab reference (75) dosed via subcutaneous injection at 160 mg on day 1 and 80 mg on day 15 followed by 40 mg dosage every 2 weeks thereafter. Responders continued treatment until week 46 and those assigned to adalimumab reference switched to BI 695501 at week 24. The primary endpoint was the proportion of patients with a clinical response defined as a 70-point or more decrease in CD Activity Index score.

At week 4, 90% of patients in the biosimilar group and 94% of patients in the adalimumab reference group had a clinical response (adjusted RR = 0.945; 90% CI, 0.87-1.028). Adverse events occurred in 63% of patients and 56% of patients, respectively, during study initiation to week 24 and 43% of patients and 34% of patients, respectively, during week 24 to week 56; researchers noted few serious adverse events throughout the study duration. BI 695501 demonstrated similar safety and efficacy among patients who switched from adalimumab reference at week 24.

“BI 695501 and adalimumab reference product showed similar rates of efficacy in this study and exploratory analysis suggested that BI 695501 is noninferior to adalimumab reference product. The safety profiles of the two drugs also appeared similar,” Hanauer and colleagues concluded. “The findings of this study support existing licensure of the biosimilar BI 695501 as an alternative to adalimumab reference product for patients with CD.”