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Study of impact of change in market economics of Biosimilars due to SPC waiver on EU 469/2009
(2023)
This research was conducted to understand and investigate the impact of SPC waiver EU 933/2019 made as an amendment to EU 469/2019. The research was conducted for analysis and extraction of the data to compile the exact number of biological products impacted with the SPC waiver. The highest sale top-5 products were identified according to the expert’s opinion. The sales revenue opportunity valuable to the top-5 products in the top-5 non-EU markets for early exports is investigated. Additionally, a survey was conducted to assess the readiness of the industry for these changes. The information from this study will be very useful to students of the biopharmaceutical market research and to the stakeholders from the biopharmaceutical industry.