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Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receive the Health Canada Approval for the Treatment of Retinal Vascular Disorders

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Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receive the Health Canada Approval for the Treatment of Retinal Vascular Disorders

Samsung Bioepis and Biogen’s Byooviz (biosimilar, ranibizumab) Receive the Health Canada Approval for the Treatment of Retinal Vascular Disorders

Shots:

  • Health Canada has approved Byooviz biosimilar referencing Lucentis for wet AMD, visual impairment due to DME, macular edema secondary to RVO, CNV secondary to PM,  CNV secondary to ocular conditions
  • The approval was based on a totality of evidence including quality, non-clinical/clinical data from the P-III study to evaluate the efficacy, safety, PK & immunogenicity of ranibizumab vs Lucentis in patients with wet AMD. The results were found to be similar
  • Byooviz marks 1st Lucentis biosimilar to be approved in Canada & 1st ophthalmology biosimilar approved in the US. In Nov’19, Samsung Bioepis & Biogen had entered into a commercialization agreement for 2 ophthalmology biosimilar i.e., SB11 & SB15

Ref: Globe Newswire | Image:Biogen

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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