Pharmacovigilance systems should cope with biosimilar introduction
{"Image DocumentName": "Pharmacovigilance systems should cope with biosimilar introduction", "Image ImageDescription": "This is not an issue unique to biosimilars \u2026.. existing issue that is highlighted and exaggerated by their arrival. Eprex\u00ae \uf0ae Biosimilar EPO \uf061 (1) \uf0ae Biosimilar EPO \uf061 (2) \uf0ae Adverse Event. Ensure traceability. Company and Regulatory Agency AE reporting systems should distinguish one manufacturers product from another. Complex, if biosimilars have the same INN as the innovator. AE reports are often incomplete eg. lot number. Repeated, uncontrolled substitution will confound accurate pharmacovigilance. Occasional changes are inevitable or necessary in chronic therapy. Prevent repeated, uncontrolled substitution.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}