Tagged as: AMD

CHMP Adopts Positive Opinion for Ranibizumab Biosimilars VISLYFA and REXATILUX

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two ranibizumab biosimilars, VISLYFA and REXATILUX, recommending granting of a marketing authorization.  Ranibizumab is a VEGF-A inhibitor, and can be used to treat macular degeneration via an intravitreal injection; the reference product, LUCENTIS, was…

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Biosimilar Regulatory Approval Updates

Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD).  Teva entered into a strategic partnership with Bioeq AG for the exclusive commercialization of ranibizumab.  According to the press release, RANIVISIO (ranibizumab) will be the first…

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