hub enables quicker turnaround times and expedites customers ’ access to raw materials that are essential in AMEA ’ s drug discovery and development whilst upholding stringent quality standards .
Building onto Avantor ’ s 2022 investment , the integration of the current distribution hub with new manufacturing operations features cGMP suites , quality testing , warehousing of certified products , batch-to-batch traceability and customized palletization capabilities .
Biocon Biologics gets positive CHMP opinion for its biosimilar to treat macular degeneration & diabetic retinopathy
Biocon Biologics Limited ( BBL ), a subsidiary of Biocon has announced that the European Medicines Agency ’ s Committee for Medicinal Products for Human Use ( CHMP ) has issued a positive opinion recommending approval of YESAFILI ®, an aflibercept biosimilar . YESAFILI ®, an ophthalmology product , is intended for the treatment of neovascular ( wet AMD ) age-related macular degeneration , visual impairment due to macular oedema secondary to retinal vein occlusion ( branch RVO or central RVO ), visual impairment due to diabetic macular oedema ( DME ) and visual impairment due to myopic choroidal neovascularisation ( myopic CNV ).
The CHMP positive opinion will be considered by the European Commission whose decision on the approval is expected by the end of September 2023 . Shreehas Tambe , CEO & Managing Director , Biocon Biologics Ltd , said : “ We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy through YESAFILI ®.”
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