Polpharma Biologics Group BV, Formycon AG and Bioeq AG, have announced that the U.S. Food and Drug Administration (FDA) has approved Cimerli (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis (ranibizumab injection).
Earlier this week, Teva Pharmaceutical Industries Ltd. (Teva) announced that the UK Medicines & Healthcare Regulatory Agency (MHRA) approved ONGAVIA, a ranibizumab biosimilar referencing Genentech’s LUCENTIS. Ranibizumab inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina.
WARSAW, Poland--(BUSINESS WIRE)--Polpharma Biologics Group announces that its joint venture company with Santo Holding (Strüngmann Group), Bioeq, has received notification by the U.S. Food and Drug Administration (FDA) that the biologics license application (BLA) for its proposed biosimilar (formally also known as BQ201, FYB201, CHS-201) to Lucentis®, a blockbuster ophthalmological drug containing ranibizumab as active drug substance, has been accepted for review.
WARSAW, Poland - ( BUSINESS WIRE ) - Polpharma Biologics Group announces that its joint venture company Bioeq, founded with Santo Holding (Strüngmann Group), has submitted a biologics license application for the biosimilar candidate of the ophthalmic drug ranibizumab (Lucentis ® ) (BLA) has filed with the US Food and Drug Administration.
WARSAW, Poland - ( BUSINESS WIRE ) - The Polpharma Biologics group announces that Bioeq, its joint venture with Santo Holding (Strüngmann Group), has submitted an application for a biological license (BLA) to the Food and Drug Administration (FDA) of United States for its biosimilar candidate of the ophthalmic drug Ranibizumab (Lucentis ® ).
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG (“Bioeq”) announce that the biologics license application (BLA) for FYB201, Formycon’s biosimilar candidate to Lucentis(R), has been recently submitted to the U.S. Food and Drug Administration (FDA).
Munich – Formycon AG (ISIN: DE000A1EWVY8/ WKN: A1EWVY) and its license partner Bioeq AG announce that the marketing authorization application (MAA) for FYB201, Formycon’s biosimilar candidate to Lucentis(R) (ranibizumab), has been submitted to the European Medicines Agency (EMA).
Bioeq Announces Coherus as Marketing and Distribution Partner for Its Biosimilar to Lucentis® (ranibizumab) in the U.S.