Ranibizumab biosimilar(Qilu Pharma)

Bayer announced Friday that the European Medicines Agency's (EMA) drug advisory committee has endorsed a higher dose version of Eylea (aflibercept) for wet age-related macular degeneration (AMD) and diabetic macular oedema (DME), stepping up competition with Roche's rival treatment Vabysmo (faricimab-svoa). An approval would mean that Eylea could be given in doses of 8mg instead of the usual 2mg, allowing for longer intervals between injections.In August, regulators in the US approved the higher dose version of Eylea, which is co-developed with Regeneron Pharmaceuticals, after clearance had initially been denied in June. Regeneron reported recently that the high-dose version generated in $43 million in the third-quarter quarter, ahead of analyst expectations, with the pace of switches from the regular-dose product described as "encouraging." For more, see Spotlight On: Early evidence that Eylea could strike back against Vabysmo.The endorsement by the EMA's Committee for Medicinal Products for Human Use (CHMP) was based on positive results from the Phase III PULSAR trial in wet AMD and the Phase II/III PHOTON trial in DME. Both met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes at week 48 with Eylea 8mg given as 12- or 16-week dosing regimens, compared to Eylea 2mg given as a fixed 8-week treatment interval."This positive CHMP opinion underscores the potential of [Eylea] 8mg to set a new benchmark for the treatment of these progressive blinding diseases," said Bayer's R&D head Christian Rommel.Vabysmo, a bispecific antibody that blocks pathways involving Ang-2 and VEGF-A, was authorised by the FDA early last year for both wet AMD and DME, and recently had retinal vein occlusion (RVO) added to its label.Separately, the CHMP also adopted a positive opinion for Qilu Pharma's Rimmyrah, a biosimilar referencing Lucentis (ranibizumab), for the treatment of wet AMD, visual impairment due to DME, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to RVO, and visual impairment due to choroidal neovascularisation.