SCD Pharm’s Ophthalmic Drug Approved by FDA: U.S. Market Entry Imminent

Anticipated to Reach 70% of Third-Quarter Operating Profit Goal

SamChunDang (SCD) Pharm announced on the 18th that it had received product import approval from the U.S. Food and Drug Administration (FDA) on the evening of the 17th from its U.S. generic ophthalmic drug partner.

After signing a supply contract for ophthalmic drugs with its U.S. partner, SCD Pharm has been pursuing development and approval applications for several years. The import approval was confirmed to be for the ophthalmic drug for glaucoma treatment, the first product submitted for approval.

A company representative explained, “The import approval is a procedure called PLAIR (Pre-Launch Activities Importation Requests), which approves the import of products before issuing a permit from the FDA. We expect the product approval to be issued in the near future.”

The representative continued, “SCD Pharm has already completed production in response to pre-orders from partners anticipating product approval and will be able to export to the U.S. on May 10th after quality control (QC) testing is completed. This is the first time a Korean company is exporting generic ophthalmic drugs to the U.S. market, and we expect to achieve our initial operating profit target of 70% in the third quarter.”

The sterile ophthalmic drug market is known as a high-profit niche market with few competitors despite the complexity of development. SCD Pharm has reaped the benefits of years of development. Although the approval process was slightly delayed due to the unexpected variable of the COVID-19 pandemic, the approval process for ophthalmic drugs has accelerated after the sterile ophthalmic drug facility passed the FDA inspection. The company expects a steady stream of product approvals and exports to begin this year.

A company representative said, “We expect that this export will accelerate negotiations for additional ophthalmic drug contracts with our partners. Once contracts are signed, we will announce them through public disclosures and the media.”

SC” Pharm has signed supply contracts for 14 generic ophthalmic drug products with partners in the U.S. and is proceeding with the approval process with them. They recently applied for product approval for the world’s Eylea biosimilar PFS·Vial.