Shots:

• The P-III Xplore study involves assessing ranibizumab biosimilar vs Lucentis in 583 patients. The study met its 1EPs demonstrating the equivalent efficacy in BCVA @ 8wks. treatment
• Additionally- the interim analysis of 6mos. data demonstrated that the biosimilar has a similar PK- safety- and immunogenicity profile compared to Lucentis. The companies plan to submit MAA to EMA and BLA to FDA in H2’21
• In July’18- the companies have entered a co-development agreement for a biosimilar of Lucentis and share equal development expenses and profits from commercialization. The companies are currently evaluating commercialization options for other countries globally

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