We are pleased to share last week’s news on the approval of the marketing authorization application of BIOEQ’s Lucentis®1 biosimilar (FYB201 - ranibizumab) granted by the United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA). It is an important milestone for Switzerland based BIOEQ, the joint venture company of Polpharma Biologics and Formycon, which out-licensed the drug to Teva Pharmaceuticals to be commercialized in Europe.
“The decision of the MHRA initiates the beginning of the commercial phase for Polpharma Biologics
as a partner for development and manufacturing and brings our biosimilar ranibizumab to the patients in UK” says Michael Soldan, CEO of Polpharma Biologics Group.
”It’s been close to 8 years of building our competencies integrating all phases of biosimilars development and commercial-scale manufacturing. Being part of bringing this important medicine
to patients with wet age-related macular degeneration, amongst other ophthalmic conditions,
we are happy to dedicate our manufacturing capabilities to deliver drugs meeting the highest quality requirements.”
1. Lucentis® is a registered trademark of Genentech Inc.