Aflibercept Reaches Blockbuster Status as Biosimilars Advance

Yesterday, Regeneron posted positive third quarter earnings results for 2018 that show a steady increase in sales for aflibercept (Eylea), a treatment for wet age-related macular degeneration (AMD).

According to the earnings report, aflibercept sales in the United States increased 7% to $1.02 billion versus third quarter 2017 results. Comparatively, in the second quarter in 2018, the drug earned $992 million in the United States. Aflibercept, now deemed a “blockbuster eye therapy,” earned developer Regeneron $1.68 billion globally, an 11% increase compared with third quarter 2017 results.

“Regeneron continues to grow and diversify our business, while continuing to deliver very strong financial results. In addition to Eylea reaching over $1 billion in quarterly US net sales, we also made significant progress with Dupixent, a key driver of future growth,” said Leonard Schleifer, MD, PhD, president and CEO of Regeneron.

Notably, however, the success of aflibercept comes before biosimilars of the drug make their way to market. Momenta Pharmaceuticals, together with Mylan, has been in the process of developing M710, a proposed biosimilar referencing Eylea. In January 2018, it was announced that the proposed biosimilar would enter a pivotal clinical trial in patients with diabetic macular edema.

Similarly, South Korea-based drug maker Altogen announced intentions earlier this year to file an Investigational New Drug application for its proposed biosimilar aflibercept, ALT-L9, in 2018 after data were released from a study that demonstrated similarity between the potential biosimilar and the reference in preclinical studies.

Biosimilars are not the only potential competitor to Eylea, however, as there are also 2 new reference products being developed for overlapping treatments. Novartis’ phase 3 brolucizumab for the treatment of AMD, and Roche’s phase 2 faricimab for the treatment of diabetic macular edema are both expected to enter the market soon, and bevacizumab, used off-label, is also widely used in treating eye disorders.

Regeneron is preparing for increased competition in the space by seeking further indications and updated dosing schedules. Currently, the FDA is scheduled to reach a decision on the drug’s use in diabetic retinopathy by May 13, 2019.