BioPlan Associates Notes Another Record Year For Drug Approvals From U.S. FDA; 35 Approvals In 2019

The US Food and Drug Administration (FDA) set an all-time record, again, for new drug approvals in 2019 with BioPlan Associates, Inc., reporting 35 biopharmaceuticals receiving full (vs. supplemental) approvals in 2019 by the agency's Center for Drug Evaluation and Research (CDER). But the majority of these (64%) were biosimilars or biobetters. Despite this record year for follow-on biologics, this could point to a trend for US innovative biologics. The Biosimilars/Biobetters Pipeline Database, includes follow-ons pipeline data, and reports over 1,050 biosimilars and 550 biobetters in various stages of development worldwide. Biosimilars, and to a lesser extent biobetter approvals will increasingly bring new players, including from developing countries, into the U.S. biopharmaceutical market, with this further increasing competition. However, very few of the now dozens of FDA-approved biosimilars have yet to be launched in the U.S.

The record number of biosimilar and biobetter approvals can also be viewed as a negative trend, with these products involving less innovation, which is particularly highly valued in the U.S. where there tends to be a bias for new(er) vs. old(er) products. The 2019 biologics approvals clearly do not yet reflect the big bio/pharmaceutical industry’s shift in its R&D and development pipelines to biopharmaceuticals vs. small molecule drugs. But this shift in R&D has clearly not yet resulted in a significant increase in the number and percentage of innovative biopharmaceutical approvals.

Although 2019 findings show a lower percentage of innovative product approvals, we consider it too early to make conclusions regarding the extent, if any, of decreasing numbers and percentages of fully innovative biopharmaceutical products entering the U.S. market. Rather, we expect a coming wave of novel product approvals, much as seen this year with biosimilars, including:

• Cellular and gene therapies,
• Live microbes as therapeutics, and
• Other novel product classes,
• More novel recombinant antibodies and other proteins.

Approvals in these classes of biologics will substantially increase the number and percentage of innovative products in coming years.

The 2019 US FDA Approvals article, published by BioPlan Associates, Inc., can be viewed on the company's website.

About BioPlan Associates, Inc.
BioPlan Associates, Inc. has been providing custom market analysis for the biotechnology industry for 30 years. We deliver the actionable information you need to make smart, aggressive decisions. Our clients take self-assured, positive marketing actions, and they get more rapid, positive results. Our technology clients get the decision-making tools they need to make decisions today. For more information, visit https://bioplanassociates.com.