FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Chinese Regulators Approve Trials for Luye’s Eylea Biosimilar

April 12, 2019
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Chinese regulators have approved Luye Pharma’s request to open clinical trials for its new antibody drug  LY09004, a biosimilar to Regeneron’s blockbuster Eylea (aflibercept) injectable, indicated for a variety of eye problems, including age-related macular degeneration and diabetic retinopathy.

The approval comes less than three months after Luye announced an agreement with AstraZeneca to market lipid-busting Xeuzhikang capsules in China, the first time a global pharma company had been granted exclusive authorization to market a drug that had been developed by an independent Chinese company.

Eylea has been a top earner for Regeneron. The company reported $1.08 billion in sales in the fourth quarter of 2018, an increase of 11 percent over the previous year.

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