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STADA and Xbrane's Xlucane (biosimilar- ranibizumab) Meet its Primary Endpoint in P-III Xplore Study

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STADA and Xbrane's Xlucane (biosimilar- ranibizumab) Meet its Primary Endpoint in P-III Xplore Study

STADA and Xbrane's Xlucane (biosimilar- ranibizumab) Meet its Primary Endpoint in P-III Xplore Study

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

  | Ref: STADA | Image: Pharmaceutical Technology

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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