Ranibizumab biosimilar is under clinical development by Lupin and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.
According to GlobalData, the latest event to affect Ranibizumab biosimilar’s likelihood of approval (LoA) and phase transition for Wet (Neovascular / Exudative) Macular Degeneration took place on 16 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.
GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ranibizumab biosimilar Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.
Ranibizumab biosimilar overview
Ranibizumab biosimilar is under development for the treatment of wet macular degeneration. It is administered as intravitreal injection. It acts by targeting VEGFA. The drug candidate is produced using high performance clonal cell lines using proprietary vectors in conventional host systems. The cell lines aid in enhanced expression of therapeutic proteins.
Lupin develops and manufactures generic and branded formulations, biotechnology products, and active pharmaceutical ingredients (APIs). It has expertise in the areas of cardiovascular, asthma, diabetic management, pediatrics, central nervous system, gastro-intestinal, anti-infectives, nonsteroidal anti-inflammatory drugs (NSAIDs), anti-TB, and cephalosporins. The company undertakes extensive research and development activities of pharmaceuticals for the treatment of migraine, gastrointestinal, psoriasis, central nervous system, cardiovascular, tuberculosis, diabetes, inflammation and others. Lupin also develops value-added generic pharmaceuticals based on its platform technologies. The company along with its subsidiaries operates manufacturing facilities in India, the US, Mexico, and Brazil. Lupin is headquartered in Mumbai, Maharashtra, India.
Quick View Ranibizumab biosimilar LOA Data
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