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
Click here to read full press release/ article | Ref: STADA | Image: Pharmaceutical Technology
The post STADA and Xbrane’s Xlucane (biosimilar, ranibizumab) Meet its Primary Endpoint in P-III Xplore Study first appeared on PharmaShots.
