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Biologics, biosimilars and biobetters: which IP protection?


Giulia Tagliafico
European and Italian Patent and Trademark Attorney
Rome, Italy

Simona Venturini
IP documentation specialist
Meda, Italy

Potentialities for development,  growth and IP protection


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Biosimilars are a great economic and legal challenge, being a sort of generics’ “problematic brothers”.
The comparison between a biosimilar and the reference original biological medicinal product is not easy at all and requires efforts, time and investment of money.
Despite these difficulties, the biosimilar market is attractive and has considerable potentiality. Considering only Italy, we can see that the current turnover of the biotech companies amounted to 7.9 billions/€ (+8%) and the 211 industries operating in our country invested 623 millions/€ in the R&D sector in the last year (about +11%). The number of patent applications filed by the Italian pharmaceutical industries increased by 54% in 2015 and, focusing on biotech-pharma, 324 biotechnology products are being developed, 60% of which are in an advanced stage ... ...

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