Boan Biotech announced that its self-developed Denosumab Injection 60mg (BA6101) has officially received approval for market from the Bolivian National Agency of Medicines and Health Technologies (Agencia Estatal de Medicamentos y Tecnologías en Salud, AGEMED).

BA6101 is a biosimilar to the reference product Prolia® (denosumab), which is widely used globally for the treatment of osteoporosis. BA6101 shares the same indications as the reference product. Developed independently based on BioAnlagen's global development strategy, this product is planned for commercialization in multiple countries and regions worldwide. In 2022, BA6101 (Boyoubei®) became the first domestically developed Denosumab injection to be approved in China. Currently, the Marketing Authorisation Application (MAA) for this product is under review in the United Kingdom, and submissions are planned for the Europ, the United States, Japan, and other countries and regions.

The development of BA6101 strictly followed biosimilar-related guidelines from China, the US, the EU, and Japan. Through a stepwise series of studies encompassing pharmaceutical quality, non-clinical, human pharmacokinetic, and clinical efficacy assessments, it has been scientifically and comprehensively demonstrated that BA6101 is overall similar to the reference originator product. The two products are highly similar in quality, safety, and efficacy, with no clinically meaningful differences. Furthermore, the production and quality control of BA6101 adhere to the highest international standards, ensuring quality assurance for its global expansion.

Boan is committed to becoming a "globally leading biopharmaceutical company," developing high-quality biologic drugs for both the Chinese and overseas markets. The company will work with partners to advance the commercial sales of BA6101 in Bolivia, actively improving local access to denosumab and providing patients with more treatment options. Beyond Bolivia, the company has also reached strategic collaborations with business partners for the commercialization of BA6101 in other Latin American countries such as Brazil, the United States, Southeast Asia, Hong Kong (China), and Macau (China). Boan will accelerate the strategic advancement of multiple biologic products, including BA6101, into global markets. By providing high-quality domestically developed biologic drugs, it aims to address unmet therapeutic needs for patients worldwide.