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.
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