Daewoong Pharmaceutical announced on Tuesday that it has inked a deal with Chime Biologics, a global biopharmaceutical contract development and manufacturing organization (CDMO), for the development and production of a Dupixent® biosimilar.

This partnership aims to lay the groundwork for developing, manufacturing, and commercializing a biosimilar version of the blockbuster immunotherapy drug Dupixent. Through this agreement, Daewoong Pharmaceutical is targeting the biosimilar market for high-value biopharmaceuticals and ramping up its global biosimilar business expansion.

The two companies have entered into a contract for the development and production of the Dupixent biosimilar. They plan to leverage Chime Biologics' expertise in biopharmaceutical development and manufacturing to enhance development stability and production efficiency.

Additionally, they've signed a separate collaboration agreement for the commercialization phase. This partnership extends beyond a typical contract development and manufacturing relationship, creating a business structure that allows both companies to jointly expand future product commercialization outcomes. With this agreement, Daewoong Pharmaceutical strengthens its biosimilar business capabilities, linking development, production, and global commercialization.

Dupixent is a biologic medication used to treat various immunological conditions, including atopic dermatitis and asthma. It works by inhibiting the signaling pathways of interleukin (IL)-4 and IL-13. The drug has expanded its approved uses to include chronic rhinosinusitis with nasal polyps, nodular prurigo, eosinophilic esophagitis, and chronic obstructive pulmonary disease (COPD).

Dupixent is projected to reach global sales of approximately 17.8 billion USD in 2025, solidifying its status as a major blockbuster drug. As it continues to grow by expanding its prescription base in immunotherapy, it's expected to generate significant interest in the biosimilar market following its patent expiration in 2029.

This contract allows Daewoong Pharmaceutical to further diversify its global biopharmaceutical portfolio. Following the success of Nabota, which has grown into a global product with annual sales of 228.9 billion KRW (about 150.8 million USD), the company aims to develop the Dupixent biosimilar as its next-generation global biopharmaceutical and establish a new growth driver.

Daewoong Pharmaceutical's Chief Executive Officer (CEO), Park Sung-soo, stated that this agreement marks a significant milestone for Daewoong Pharmaceutical in expanding the global biosimilar business. It will strengthen our capabilities across the entire value chain - from development to production and commercialization of biosimilars for major blockbuster biologics - ensuring it consistently brings competitive products to the global market.

In related news, Daewoong Pharmaceutical's type 2 diabetes treatment recently received regulatory approval in Mexico, a key market in Latin America.

The company emphasized the significance of this approval as their first product registration in a major Latin American country. Daewoong Pharmaceutical is actively pursuing global expansion. Among the 12 Latin American countries where it has sought product approval, the company has secured approvals in seven, including Mexico, Ecuador, El Salvador, Guatemala, Honduras, the Dominican Republic, and Panama.

Daewoong Pharmaceutical has been steadily expanding its collaboration on the Envlo project with Arcera, its local partner with a strong distribution network across Latin America. The company has signed supply contracts for Envlo with key markets including Brazil and Mexico, accelerating its penetration into local markets.

Daewoong Pharmaceutical announced on Tuesday that it has inked a deal with Chime Biologics …

Daewoong Pharmaceutical Expands Biosimilar Push With Dupixent Copy Deal and Global CDMO Partnership