Ocumension Therapeutics (HKG: 1477) and Shandong Boan Biotechnology Co., Ltd (HKG: 6955) have jointly announced the submission of a market approval filing to the National Medical Products Administration (NMPA) for their co-developed biosimilar version of Bayer’s Eylea (aflibercept). This biosimilar has the potential to be the latest entry in the competitive biosimilars market in China, offering an alternative for the treatment of various eye conditions, including wet age-related macular degeneration and diabetes macular edema .
Eylea, since its approval in China in 2018, has been indicated for a range of eye diseases, and the biosimilar version developed by Ocumension and Boan is eligible for approval of all Eylea’s indications, as per the “Biosimilar similarity evaluation and indication extrapolation technical guidelines” released by the Center for Drug Evaluation (CDE) in February 2021. This regulatory framework allows biosimilars to be approved for all the indications of the original product, streamlining the process and potentially accelerating the time to market .
The biosimilar, if approved, would be the ninth indication for the drug, which has already proven its efficacy in treating non-small cell lung cancer and various other cancers. The market for biosimilars is expected to grow as patents for biologic drugs expire, and more biosimilars gain regulatory approval. This filing is a significant step forward in the biosimilar space, reflecting the ongoing commitment of Chinese biopharmaceutical companies to develop and market innovative treatments that can improve patient outcomes and potentially reduce healthcare costs .
The partnership between Ocumension Therapeutics and Shandong Boan Biotechnology is a testament to the collaborative efforts within the Chinese biopharmaceutical industry to bring biosimilars to market. As the biosimilars market continues to evolve, such collaborations will play a crucial role in shaping the future of healthcare in China and globally .- Flcube.com
