The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade.
The FDA has approved Amgen’s infliximab biosimilar, Avsola (infliximab-axxq), referencing Remicade. The biosimilar was approved to treat Crohn disease (CD), pediatric CD, ulcerative colitis (UC), pediatric UC, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
The biosimilar was studied in a phase 3 clinical trial in patients with RA.
In the multicenter, randomized, double-blind, active-controlled, multiple-dose study, 556 patients were treated with the biosimilar (n = 278) or the reference (n = 278) at a dose of 3 mg/kg on day 1 and at weeks 2 and 6, then every 8 weeks until week 22. The primary end point of the study was response difference in terms of the ACR criteria for 20% improvement (ACR20) at week 22.
Patients who completed the 22 weeks who were initially given the reference drug were randomized to continue treatment with the reference (n = 121) or switch to the biosimilar (n = 119) and receive treatment until week 46; patients randomized to the biosimilar continued their therapy (n = 244) until week 46.
The response difference in terms of ACR20 at week 22 was 9.37 (90% CI, 2.67-15.96), and, write the authors, results of the ACR20, ACR50, and ACR70 response rates across groups were similar, with overlapping 95% CIs of ACR response rates between groups at all and with narrow response differences at all time points.
Additionally, a phase 1 clinical trial, reported this October, demonstrated the pharmacokinetic (PK) similarity between the biosimilar and its US and EU references.2
The randomized, single-blind, single-dose, 3-arm, parallel-group study was conducted among healthy volunteers at 2 centers in Australia. In total, 49 individuals were dosed at 5 mg/kg with the biosimilar (ABP 710), 50 with US-licensed reference infliximab, and 49 with EU-licensed reference infliximab. The primary end point was area under the serum concentration—time curve from time 0 extrapolated to infinity (AUCinf).
The geometric mean ratio of AUCinf was 0.89 between ABP 710 and the US-licensed reference, 1.00 between ABP 710 and the EU-licensed reference, and 1.11 between the US-licensed reference and the EU-licensed reference. The 90% CIs of the geometric mean ratios were fully contained within the prespecified PK equivalence margin of 0.80 to 1.25. Additionally, the 90% CIs for the ratio of least squares geometric means for peak serum concentration and AUC to the last measurable concentration were fully contained within the same margin, confirming PK similarity.
FDA approval of the biosimilar comes not long after the drug maker withdrew its application for the biosimilar from the European Medicines Agency. Amgen said in a letter to the regulator that its withdrawal was due to a change in product strategy.
Avsola joins 3 other FDA-approved infliximab biosimilars in the United States: Inflectra, Renflexis, and Ixifi. Only Inflectra and Renflexis are commercially available in the United States; Pfizer, developer of Ixifi, said when its product was approved that it had no plans to launch Ixifi in the United States, but would continue to focus its efforts on Inflectra.
No launch date for Avsola has been announced.
References
1. Genovese M, Sanchez-Burson J, Balázs É, Everding A, Oh MS, Fanjiang G, Cohen S. Efficacy of biosimilar candidate ABP 710 in a phase 3 study in subjects with moderate to severe RA: additional analysis focusing on the ACR individual components. Presented at: The American College of Rheumatology Annual Meeting, November 8-13, 2019; Atlanta, Georgia. Abstract 519.
2. Chow V, Oh M, Gesner MA, Fanjiang G. Pharmacokinetic similarity of ABP 710, a proposed biosimilar to infliximab: results from a randomized, single-blind, single-dose, parallel-group study in healthy subjects [published online October 19, 2019]. Clin Pharmacol Drug Dev. doi: 10.1002/cpdd.738.
Eye on Pharma: Bevacizumab Update; Samsung Bioepis, J&J Settlement; Another EU Trastuzumab
December 6th 2023Outlook Therapeutics provides an update on the development of its bevacizumab candidate for age-related macular degeneration; Samsung Bioepis settles with Johnson & Johnson (J&J) over its ustekinumab biosimilar candidate; and the European Union gains another trastuzumab biosimilar.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilars Regulatory Roundup for September 2023—Podcast Edition
October 1st 2023On this episode, we discuss several regulatory updates from around the globe, including some European and Japanese approvals, the FDA’s 2-day workshop on the present science behind clinical efficacy testing for biosimilars, and streamlining biosimilar development.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).