[Edaily Reporter Shin Ha-yeon] #SunBio is seeing growing expectations for expanded raw material supply and increased royalty revenue after the biosimilar product for which it transferred technology received marketing approval from the U.S. Food and Drug Administration (FDA).

SunBio announced on the 18th that “Ennumo,” a biosimilar version of the neutropenia treatment PEG-filgrastim, which it licensed to global pharmaceutical company Intas Pharmaceuticals, has received final marketing approval from the U.S. FDA.

Ennumo is a biosimilar of “Neulasta,” a blockbuster treatment developed by U.S. pharmaceutical company Amgen. Neulasta is a leading biologic used to treat neutropenia—a condition that occurs during cancer treatment—and has generated substantial sales in the global market.

SunBio is the exclusive supplier of the high-quality PEG derivatives essential for the production of Ennumo. Accordingly, an increase in raw material supply volumes is expected to coincide with the launch of sales in the U.S. market. Under the technology transfer agreement, the company will also secure royalty income linked to U.S. sales performance and milestone payments following FDA approval.

Previously, this biosimilar has been sold in the European and Canadian markets through Intas and Accord Pharma, generating revenue from raw material supply and royalty income. With this entry into the U.S. market—the world’s largest pharmaceutical market—the company expects the scale of related revenue to grow significantly as its sales territory expands.

A SunBio official stated, “Our biosimilar development capabilities and PEGylation technology, which have been validated in the European and Canadian markets, have been proven once again through U.S. FDA approval,” adding, “With the U.S. launch, the expansion of active ingredient supply and increased royalty revenue will contribute to the company’s growth and improved profitability.”