Non-biotechnologically manufactured biosimilars

Can non-biotechnologically manufactured biosimilars be approved under Art. 13 TPA?

Biological medicinal products which are non-biotechnologically manufactured and which do not therefore fall under Art. 12, Para. 5 and 6 TPLO,may be approved as biosimilars pursuant to Art. 13 TPA in conjunction with Art. 17, Para. 1, Para. 1, Letter b TPO. This only applies, however, if they have been previously approved by the EMA or FDA. According to Art. 17, Para. 1, Letter b TPO, in the case of biosimilar applications pursuant to Art. 4, Para. 1, Letter anovies TPA – and thus specifically biological medicinal products as per Art. 2, Para. 1, Letter d TPLO – Swissmedic does not conduct its own scientific review if the EMA or FDA has already granted an approval. Biological medicinal products developed as biosimilars and not biotechnologically manufactured may therefore be approved in Switzerland under Art. 17 TPO.

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Dr. Katharina Oehler
Scientific and Managing Director
T +41 44 787 70 20
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