Trends and Insights in Biological Drug Approvals by the US Food and Drug Administration: 2013–2022
Year: 2025
Type: article
Abstract: Biopharmaceuticals are medications derived from biological sources such as bacteria, humans, and animals, as well as from nucleic acids, sugars, and proteins.[1] The category of biological drugs has rapidly grown over the past decade. Initially focused on insulin, the pharmaceutical and biotechnology industries now offer a wider range, including popular monoclonal antibodies (mAbs) and other therapies such as small interfering RNA, cytokines, and enzymes.[2] Biologics are effective treatments for conditions like diabetes, cancer, and rheumatoid arthritis, but they are expensive to produce.[3] This retrospective observational analysis was planned to analyze all US Food and Drug Administration (FDA)-approved biologicals for cancer, autoimmune, and other disorders, including rare ones, from 2013 to 2022. This was a retrospective, observational, record-based investigation. From 2013 to 2022, all innovative drugs and biologics approval data were sampled for analysis. US FDA biologics and biosimilar drug approval data were obtained from the FDA database website. All therapeutic proteins, antibodies, vaccines, small interfering RNA, cytokines, enzymes, and peptide medicines approved by the US FDA in a given year were deemed biologicals. PubMed, clinicaltrials.gov, and Cochrane databases were searched for drug-related information. Data were entered into MS Excel 2022 for tabulation and analysis. Analyses used descriptive statistics. The US FDA approved 428 pharmaceuticals from 2013 to 2022, averaging 43 innovative drugs per year. Most medications were approved (n = 59) in 2018, 53 in 2020, and 50 in 2021. The lowest number of medications approved was 22 in 2016, followed by 27 in 2013 and 37 in 2022, as shown in Tables 1 and 2. Between 2013 and 2022, 82 antibodies were approved. The highest approvals were 12 in 2018 and 2020, and the lowest was 2 in 2013. Thirty-four of these 82 antibodies are orphan medications, and 31 are first-in-class. Humanized antibodies were approved most often (n = 41; 50%), followed by human (n = 32; 39%) and chimeric (n = 9; 11%). Most administrations were intravenous (n = 55; 67%), followed by subcutaneous (n = 25; 30%) and intraocular (n = 2; 2%). Antibodies were most commonly provided for cancer treatment (n = 37; 45%), followed by autoimmune disorders, endocrine disorders, and blood medications. In the last decade, 27 antibodies – 33.7% of all licensed antibodies – have been designated orphan drugs. The US FDA authorized 22 biologic medications with Black Box Warnings throughout the same period. In 2017 and 2020, four Black Box Warning medications were approved. The US FDA has approved 427 medications in the past decade, including 40 biosimilars. Biosimilars make for 9.35% of authorized medications. The most biosimilars (n = 10) were approved in 2019. Only four interchangeable biological drugs were approved.Table 1: Summary of all biosimilar drugs approved from 2013 to 2022Table 2: Summary of all biologics except antibodies approved by the US Food and Drug Administration from 2013 to 2022The last decade (CY2013–CY2022) saw 57.8% (n = 82) of biologicals approved as antibodies. Therapeutic monoclonal antibody sales reached US$115.2 billion in 2018. It was expected to be valued $150 billion in 2019 and $300 billion in 2025.[4] Due to the rise in complicated diseases, including cancer and autoimmune disorders, and the need for more personalized treatment strategies, targeted treatments are in demand.[5] In the past decade, 72% (n = 102) of approved antibodies for cancer treatment target various tumors. Therapeutic mAbs focus on overexpressed growth factor receptors like epidermal growth factor receptor and HER2. By blocking these receptors, mAbs disrupt signaling, slow tumor growth, induce apoptosis, and increase chemotherapy sensitivity.[6] Cancer treatments obtained the most fast-track, accelerated, and priority approvals from 2000 to 2017.[7,8] The high demand for cancer treatments and their past success in expediting approval based on surrogate endpoints may have contributed to their latest approval rate.[9] A total of 27 antibodies, or 33.7%, received orphan medication classification, reflecting the commitment to treating rare diseases with limited therapies. “First-in-class” medications, which treat conditions through unique mechanisms, made up about 19% of biologics, indicating novel therapeutic approaches. Biosimilars, as cost-effective alternatives to reference biologics, accounted for 9.35% of US FDA-approved medications in the last decade, with approvals peaking at 10 in 2019. The COVID-19 pandemic impacted biosimilar approvals, with only 3 in 2020 and 4 in 2021. The recent approval of interchangeable biosimilars is a significant milestone. Biosimilars are affected by pricing strategies, patent expirations, and healthcare provider adoption.[10] Besides antibodies and biosimilars, biologics include therapeutic proteins, vaccines, small interfering RNA, cytokines, enzymes, and peptide medicines. In Table 2, biologic names, indications, and approval years are listed. Biologics, particularly antibodies, have driven US FDA approvals during the past decade. The rise of anticancer, autoimmune, and blood illnesses shows the growing treatment landscape. The rise of biosimilars and interchangeable biosimilars shows a shift towards cheaper alternatives. This report illuminates the changing drug approval landscape, enabling biologics research and development. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.
Source: Indian Journal of Public Health
Authors: Ajay Kumar Shukla, Saurav Misra
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $48
OpenAlex ID: W7117722155