Table 2 Biopharmaceuticals approved in the US and/or EU January 2014–July 2018 by category

From: Biopharmaceutical benchmarks 2018

CategoryProducts (by trade name)
Genuinely new biopharmaceuticalsAdynovi/Adynovate, Vonvendi, Obizur, Elocta/Eloctate, Andexxa, Rebinyn/Refixia, Alprolix, Idelvion, Suliqua/Soliqua, Xultophy, Myalepta/Myalept, Ozempic, Eperzan/Tanzeum, Trulicity, Oxervate, Plegridy, Shingrix, Trumenba, pandemic influenza vaccine H5N1, Mosquirix, Aimovig, Crysvita, Fasenra, Hemlibra, Ilumya, Trogarzo, Bavencio, Besponsa, dinutuximab beta Apeiron/Qarziba, Dupixent, Imfinzi, Kevzara, Kyntheum/Siliq, Rituxan Hycela, Tecentriq, Tremfya, Zinplava, Anthim, Cinqair/Cinqaero, Darzalex, Empliciti, Lartruvo, Taltz, Blincyto, Cosentyx, Keytruda, Nivolumab BMSa/Opdivo, Nucala, Praluent, Praxbind, Repatha, Unituxina, Cyramza, Entyvio, Sylvant, Palynziq, Lamzede, Brineura, Mepsevii, Kanuma, Strensiq, Vimizim, Tegsedi, Luxturna, Spinraza, Exondys 51, Imlygic, Alofisel, Kymriah, Yescarta, Strimvelis, Zalmoxis
BiosimilarsSemglee, insulin lispro Sanofi, Lusduna, Abasaglar/Basaglar, Bemfola, Movymia/Terrosa, Retacritb, Fulphila, Nivestym/Nivestimb, Zarxiob, Accofil, Halimatoz/Hefiya/Hyrimoz, Herzuma, Kanjinti, Mvasi, Trazimera, Zessly, Amgevita/Amjevita/Solymbic, Blitzima/Truxima/Ritemvia/Rituzena, Cyltezo, Imraldi, Ixifi, Ogivri, Ontruzant, Renflexis/Flixabi, Rixathon/Riximyo, Inflectra/Remsimab, Erelzi, Benepali
Reformulated, me-too, different indication, and relatedAfstyla, Vihuma/Nuwiq, Iblias/Kovaltry, Ixinity, Admelog, Fiasp, Toujeo, Afrezza, Rekovelle, Natpara, Natpar, Saxenda, Ristempaa, Heplisav-b, Gardasil 9, Ocrevus, Portrazza, Zinbrytaa, Oncaspar, Lifmior, Spectrila
Previously approved elsewhereRixubis, Ruconest, Ryzodeg 70-30/Ryzodeg, Tresiba, Bexsero, Mylotarg, Gazyva/Gazyvaro
  1. aProducts were both approved and subsequently withdrawn from one or both regions within the survey timeframe.
  2. bBiosimilars approved in one region since 2014, but which were approved in the other region before 2014.