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 large molecule modalities continued with year with 12 novel large molecules, 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 12 large molecules approved in 2019 along with two peptides.1
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2019 Novel Large Molecule and Peptide Drug Approvals
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- This doesn’t include biologic agents like vaccines or gene therapies like Zolgensma, covered under the FDA’s Biologic License Application Approvals.