Biofrontera

About Biofrontera

Biofrontera Inc. is a U.S.-based biopharmaceutical company focused on the commercialization of dermatological products. Incorporated on March 3, 2015, the company operates as a spin-off from the German-based Biofrontera AG, which was founded in 1997 by its current CEO, Prof. Hermann Lübbert. Prof. Lübbert, who holds a Ph.D. in Biology and has extensive experience in academic research and management at Sandoz and Novartis, now leads the U.S. entity, bringing deep industry knowledge to its operations. The company completed its initial public offering on the Nasdaq in October 2021.

The firm's business model centers on licensing and selling pharmaceutical products directly to dermatologists and other healthcare providers in the United States. Its revenue is generated through the sale of its portfolio of FDA-approved drugs. A significant strategic milestone occurred in June 2025 when Biofrontera Inc. acquired all U.S. rights for its flagship products, Ameluz® and RhodoLED®, from its former parent company. This restructuring shifted the company from a transfer pricing model to a more favorable royalty-based agreement, reducing royalty rates and giving it full control over manufacturing, regulatory, and commercial responsibilities in the U.S. market.

Biofrontera's core offering is the drug-device combination of Ameluz® and the BF-RhodoLED® lamp. This system provides photodynamic therapy (PDT) for the treatment of actinic keratoses, which are pre-cancerous skin lesions commonly caused by sun exposure. Ameluz® is a topical gel applied to the lesions, which is then activated by the red light from the BF-RhodoLED® device. The FDA first approved Ameluz® in May 2016. Subsequent FDA approvals have expanded its use, including an increase in the allowable dosage per treatment session in October 2024, allowing for the treatment of larger skin surface areas. The company is also conducting clinical trials to extend the approved indications for Ameluz® to include superficial basal cell carcinoma and moderate to severe acne. The company’s portfolio also includes Xepi®, a topical antibiotic for treating impetigo, although it has been designated as held for sale as of mid-2025.