2019 Large Molecule Drug Approvals

2019 was another big year for novel drug approvals (48 in total) though it wasn’t the record year of 2018 (with 59). The overall explosion in biologic drugs / non-small molecule modalities continued with year with 14 novel biologic drugs, including 3 monoclonal antibodies, a recombinant fusion protein (Reblozyl), 3 ADCs, an siRNA drug (Givlaari), an antisense oligonucleotide (Vyondys 53), a nanobody (Cablivi) and a single-chain antibody (Beovu). Here’s a visual summary of the 14 biologics approved in 2019. This doesn’t include biologic agents like vaccines or gene therapies like Zolgensma, covered under the FDA’s Biologic License Application Approvals.

Skyrizi
Polivy
Givlaari
Padcev
Vyodys 53
Evenity
Beovu
Adakveo
Cablivi
Enhertu
Jeuveau
Reblozyl
Vyleesi
Scenesse
2019 Large Molecule + Peptide Drug Approvals

For a graphic of 2019 small molecule drugs, see this previous article. To compare these statistics to last year, see this previous article.

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