Biosimilar Matches Aflibercept for Diabetic Macular Edema

TOPLINE:

A biosimilar demonstrated comparable efficacy and safety to aflibercept in treating diabetic macular edema. The vascular endothelial growth factor (VEGF) inhibitor was one of two aflibercept biosimilars approved by the US Food and Drug Administration in May.

METHODOLOGY:

• Researchers conducted a double-masked, randomized trial with 355 participants at 77 centers in the United States, Europe, Japan, and India to compare the biosimilar MYL-1701P (Yesafili [aflibercept-jbvf], Biocon) with reference aflibercept (Eylea, Regeneron).
• Participants were aged ≥ 18 years with type 1 or type 2 diabetes and central diabetic macular edema, with a best-corrected visual acuity letter score of 7338.
• Participants received either 2 mg of MYL-1701P or reference aflibercept via intravitreal injection every 4 weeks for 16 weeks, then every 8 weeks through week 48.
• The primary outcome was the mean change in best-corrected visual acuity from baseline at week 8.

TAKEAWAY:

• MYL-1701P demonstrated clinical equivalence in efficacy to reference aflibercept, with an adjusted mean difference in best-corrected visual acuity of 0.04 letters at week 8 (90% CI, −1.16 to 1.24 letters).
• The mean change in central subfield thickness at week 8 was −112 μm for MYL-1701P and −124 μm for reference aflibercept, with an adjusted mean difference of 12 μm (90% CI, −3 to 26 μm).
• The incidence of treatment-emergent ocular adverse events was comparable with MYL-1701P (30.9%) and reference aflibercept (29.5%), with no new safety concerns identified.
• The incidence of treatment-induced or treatment-boosted antidrug antibodies was 2.8% in patients who received MYL-1701P and 5.7% in those who received the reference medication.

IN PRACTICE:

“To our knowledge, this phase 3, 52-week, randomized clinical trial was the first to assess biosimilarity of an aflibercept biosimilar, MYL-1701P, to reference aflibercept in the [diabetic macular edema] population,” the authors of the study wrote. “Despite an abbreviated development pathway for biosimilars, thus far, there appears to be sufficient checks and balances to protect patient safety. Postmarketing pharmacovigilance will add data, which will hopefully bolster the confidence of treating physicians in using these products.”

SOURCE:

Susan B. Bressler, MD, with the Wilmer Institute at Johns Hopkins University School of Medicine in Baltimore was the corresponding author of the study, which was published online on September 12 in JAMA Ophthalmology.

LIMITATIONS:

Most participants were Asian or White individuals. Some patients had delayed or missed doses because of the COVID-19 pandemic.

DISCLOSURES:

Viatris, a developer of the biosimilar, funded the study. Coauthors included employees of Viatris and Biocon. Other authors disclosed ties to those companies as well as other pharmaceutical companies.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.