Aflibercept biosimilar is under clinical development by Qilu Pharmaceutical and currently in Phase III for Wet (Neovascular / Exudative) Macular Degeneration. According to GlobalData, Phase III drugs for Wet (Neovascular / Exudative) Macular Degeneration have a 73% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Aflibercept biosimilar’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.
Aflibercept biosimilar overview
Aflibercept biosimilar (QL-1207) is under development for the treatment of diabetic macular edema and wet age-related macular degeneration. The drug candidate is a recombinant vascular endothelial growth factor receptor fused with an antibody (fusion protein). It is administered through intravitreal route. QL-1207 acts by targeting vascular endothelial growth factor (VEGF).
Qilu Pharmaceutical overview
Qilu Pharmaceutical (Qilu) develops, manufactures and markets generic drugs and active pharmaceutical ingredients (API’s). It offers products for various therapies such as oncology, cerebrovascular and cardiovascular diseases, infectious diseases, psychological and neurological diseases, respiratory system and eye diseases. The company’s generic drugs include lyophilized powder for injection, powder for injection, small volume parenteral solution, tablets, capsules, granules, ophthalmic solutions, creams, ointments, inhalers and spray; and synthesized, lyophilized, sterile crystallized and fermented APIs. Qilu operates manufacturing facilities with various certifications of US FDA, European Medicines Agency (EMA), PMDA of Japan, Medicines and Healthcare products Regulatory Agency (MHRA) of UK, Therapeutic Goods Administration (TGA) of Australia and other national regulatory authorities. The company markets products across North and South America, Europe, Asia Pacific, and the Middle East and Africa. Qilu is headquartered in Jinan, Shandong, China.
For a complete picture of Aflibercept biosimilar’s drug-specific PTSR and LoA scores, buy the report here.