FDA Approved Biologics by Year: A Reference Guide

By Dr. Zubair Khalid, DVM, MS, PhD · 2026-08-11

Introduction to FDA Approved Biologics by Year

What Are Biologics?

Biologics are therapeutic products derived from living systems—mammalian cell lines, bacterial cultures, yeast, or transgenic organisms—rather than produced by chemical synthesis. The category encompasses monoclonal antibodies (mAbs), recombinant proteins, enzymes, cytokines, growth factors, vaccines, allergenic extracts, gene therapies, and cell-based therapies. Unlike small molecule drugs, which are typically 100–1000 Da and chemically well-defined, biologics are large (typically 10–1000 kDa), structurally heterogeneous, and highly sensitive to manufacturing conditions.

The regulatory distinction matters operationally. A biologic is regulated under Section 351 of the Public Health Service (PHS) Act, while a small molecule drug is regulated under the Federal Food, Drug, and Cosmetic Act. This difference drives the approval pathway, post-marketing requirements, and manufacturing change oversight. For a deeper treatment of the regulatory framework, see FDA Regulations for Biologics.

Why Track Approvals by Year?

Year-by-year approval data serves as a barometer for the state of biologic development. Approval counts reflect the maturity of platform technologies, the productivity of discovery pipelines, the efficiency of regulatory review, and the strategic priorities of the biopharmaceutical industry. For a working scientist, this data informs competitive intelligence, resource allocation, and portfolio benchmarking. If your organization is deciding whether to invest in an oncology bispecific or a gene therapy platform, understanding historical approval patterns—by therapeutic area, modality, and review pathway—provides a rational basis for that decision.

This article compiles the key trends, regulatory mechanisms, and data sources needed to interpret FDA biologic approvals by year. It is written for scientists who need applied, decision-useful reference material, not for regulatory historians.

Historical Trends in Biologic Approvals

Early Years (1980s-1990s)

The modern biologic era began in 1982 with the approval of recombinant human insulin (Humulin), the first recombinant DNA-derived therapeutic. Through the 1980s, approvals were sparse—typically one to three per year—and dominated by recombinant versions of endogenous proteins: growth hormone (Protropin, 1985), tissue plasminogen activator (Activase, 1987), erythropoietin (Epogen, 1989), and granulocyte colony-stimulating factor (Neupogen, 1991).

The 1990s saw the first therapeutic monoclonal antibodies enter the market. Muromonab-CD3 (Orthoclone OKT3, 1986) was an early outlier, but the field accelerated with rituximab (Rituxan, 1997), trastuzumab (Herceptin, 1998), infliximab (Remicade, 1998), and alemtuzumab (Campath, 2001). These approvals established the mAb platform as commercially viable and clinically transformative, particularly in oncology and immunology. Annual approval counts remained modest—typically 5–15 total biologics per year—reflecting the novelty of the manufacturing platforms and the caution of regulators.

Expansion in the 2000s

The 2000s marked a period of platform maturation. CHO (Chinese hamster ovary) cell expression systems became standardized, protein A chromatography for antibody purification became routine, and analytical methods—particularly surface plasmon resonance and cell-based potency assays—matured to the point where regulators could confidently assess batch-to-batch consistency.

Approval counts rose to roughly 20–30 biologics per year by the late 2000s. The therapeutic focus expanded beyond oncology and rheumatology into ophthalmology (ranibizumab, Lucentis, 2006), multiple sclerosis (natalizumab, Tysabri, 2004; fingolimod is a small molecule, but ocrelizumab followed in 2017), and metabolic disease. The 2006 approval of the human papillomavirus vaccine (Gardasil) demonstrated that complex virus-like particle vaccines could be manufactured at scale.

Recent Surge (2010s-Present)

The 2010s and early 2020s have seen an unprecedented acceleration. Annual biologic approvals now routinely exceed 40–50, with 2023 setting records. Several factors drive this surge:

• Immuno-oncology: PD-1/PD-L1 checkpoint inhibitors (pembrolizumab, 2014; nivolumab, 2014; atezolizumab, 2016) created a new therapeutic paradigm and a wave of follow-on combinations.
• Bispecific and multispecific antibodies: Blinatumomab (2014), emicizumab (2017), and faricimab (2022) demonstrated that engineered formats beyond the canonical IgG could be approved and commercialized.
• Gene and cell therapies: The 2017 approvals of tisagenlecleucel (Kymriah) and axicabtagene ciloleucel (Yescarta) opened the cell therapy era; adeno-associated virus (AAV) gene therapies followed (onasemnogene abeparvovec, Zolgensma, 2019).
• Biosimilar market entry: Beginning with filgrastim-sndz (Zarxio) in 2015, biosimilars have added to the total approval count, though they represent a distinct category.

The recent surge is not merely a counting artifact. The modalities themselves have diversified: antibody-drug conjugates (ADCs), bispecific T-cell engagers (BiTEs), and mRNA-based therapeutics (notably COVID-19 vaccines in 2021) have all received approvals within the last decade.

Regulatory Pathways for Biologic Approval

Biologics License Application (BLA)

The Biologics License Application (BLA) is the primary submission pathway for a new biologic. A BLA must demonstrate safety, purity, and potency—the statutory standard for biologics—through nonclinical studies, clinical trials, and extensive manufacturing information. The BLA includes chemistry, manufacturing, and controls (CMC) data that must establish product consistency, stability, and absence of adventitious agents.

The BLA pathway differs from the New Drug Application (NDA) used for small molecules in several critical respects. The NDA standard is safety and effectiveness; the BLA standard is safety, purity, and potency. More practically, the BLA requires a full description of the manufacturing facility, cell bank systems, and viral clearance validation. Because biologics are defined by their manufacturing process, process changes after approval require careful regulatory management. The FDA Post Approval Changes Guidance Biologics provides the current framework for such changes. For a comprehensive overview of the BLA process, see Biologics License Application FDA.

Biosimilar and Interchangeable Products

A biosimilar is a biologic that is highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety, purity, or potency. Biosimilars are approved under the Biologics Price Competition and Innovation Act (BPCIA) of 2009, which created an abbreviated pathway (351(k)) that relies on analytical similarity, animal studies, and clinical immunogenicity/pharmacokinetic data rather than full efficacy trials.

An interchangeable product is a stricter designation: it can be substituted for the reference product without the prescriber's intervention, subject to state pharmacy laws. Interchangeability requires additional data demonstrating that switching between the biosimilar and reference product does not increase safety risks or diminish efficacy.

In approval-by-year data, biosimilars are counted separately from new biologics in most analyses. This distinction matters: a year with 15 biosimilar approvals and 5 new biologics is very different from one with 20 new biologics.

Accelerated Approval and Breakthrough Therapy

The FDA has several expedited programs that materially affect approval timelines:

1. Fast Track: Accelerates review for drugs treating serious conditions with unmet medical need.
2. Breakthrough Therapy: Provides intensive FDA guidance and rolling review for drugs showing substantial improvement over existing therapies in early clinical data.
3. Accelerated Approval: Allows approval based on a surrogate endpoint (e.g., tumor shrinkage) that is reasonably likely to predict clinical benefit, with a requirement for confirmatory post-marketing trials.
4. Priority Review: Shortens the review clock from 10 months to 6 months.

These programs have compressed development timelines substantially. Pembrolizumab received accelerated approval in 2014 based on tumor response rates, with confirmatory trials completed later. The practical effect is that the gap between first-in-human dosing and approval has narrowed from a historical 10–12 years to as little as 5–7 years for breakthrough-designated products. For a detailed treatment of these mechanisms, see FDA Approval Process for Biologics.

Key Therapeutic Areas and Notable Approvals

Oncology Biologics

Oncology has been the dominant therapeutic area for biologic approvals since the late 1990s. The table below summarizes landmark oncology biologics and their approval years:

The checkpoint inhibitor era fundamentally changed the oncology landscape. PD-1/PD-L1 inhibitors have received approvals across dozens of indications, from melanoma to non-small cell lung cancer to microsatellite instability-high (MSI-H) tumors regardless of tissue of origin—the latter being a landmark tissue-agnostic approval (pembrolizumab, 2017).

Immunology and Inflammation

Biologics for autoimmune and inflammatory diseases represent the second-largest therapeutic category. Tumor necrosis factor (TNF) inhibitors dominated the early era: infliximab (1998), etanercept (1998), adalimumab (2002), certolizumab pegol (2008), and golimumab (2009). These were followed by agents targeting other pathways:

• IL-6 receptor: Tocilizumab (2010)
• IL-17/IL-17R: Secukinumab (2015), ixekizumab (2016)
• IL-23/IL-12: Ustekinumab (2009), guselkumab (2017), risankizumab (2019)
• Integrins: Natalizumab (2004), vedolizumab (2014)
• BAFF/BLyS: Belimumab (2011)

The dermatology space has been particularly active. For a condition-specific overview, see FDA Approved Biologics for Atopic Dermatitis. Dupilumab (2017), an IL-4Rα antagonist, has become a blockbuster across atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps.

Rare Disease and Gene Therapies

Rare disease biologics have expanded dramatically, driven by the Orphan Drug Act (1983) and, more recently, by platform technologies for gene and cell therapy. Notable approvals include:

• Enzyme replacement therapies: Imiglucerase (Cerezyme, 1994) for Gaucher disease; agalsidase beta (Fabrazyme, 2003) for Fabry disease; alglucosidase alfa (Myozyme, 2006) for Pompe disease.
• Antisense oligonucleotides: Nusinersen (Spinraza, 2016) for spinal muscular atrophy (SMA)—technically an oligonucleotide, not a biologic, but often grouped with biologics in industry analyses.
• AAV gene therapies: Voretigene neparvovec (Luxturna, 2017) for RPE65-associated retinal dystrophy; onasemnogene abeparvovec (Zolgensma, 2019) for SMA; etranacogene dezaparvovec (Hemgenix, 2022) for hemophilia B.
• Cell therapies: Tisagenlecleucel and axicabtagene ciloleucel (2017) for hematologic malignancies; liso-cel (2021) and ide-cel (2021) expanding the CAR-T repertoire.

The rare disease space illustrates a critical point about approval-by-year data: a single approval can represent a therapeutic breakthrough for a small patient population, and counting approvals alone understates the clinical impact.

Factors Influencing Approval Rates

Scientific Advances

Approval rates track scientific platform maturity. The monoclonal antibody approval wave of the late 1990s followed the development of chimerization and humanization technologies (1980s–1990s) and phage display for fully human antibodies (1990s). The current wave of bispecifics and ADCs follows advances in protein engineering—knobs-into-holes technology for heterodimerization, site-specific conjugation chemistries, and stable linker design.

Similarly, gene therapy approvals followed decades of work on AAV capsid engineering, promoter design, and manufacturing scale-up. The approval of valoctocogene roxaparvovec (Roctavian, 2023) for hemophilia A, using a liver-tropic AAV5 capsid, reflects the maturation of these platforms.

Regulatory Reforms

The FDA has actively shaped approval rates through policy. Key reforms include:

• Prescription Drug User Fee Act (PDUFA) of 1992: Established user fees to fund faster review, reducing median review times from over 20 months to under 10 months.
• BPCIA (2009): Created the biosimilar pathway, adding a new category of approvals.
• 21st Century Cures Act (2016): Encouraged the use of real-world evidence and patient-reported outcomes in regulatory decision-making.
• Accelerated approval reforms (2022–2023): Tightened requirements for confirmatory trials after concerns about delayed or failed confirmations.

These reforms have made the FDA more predictable and faster, which in turn has encouraged more investment in biologic development.

Market and Economic Pressures

Commercial considerations influence which biologics reach the market and when. The patent cliff for blockbuster biologics (e.g., adalimumab, 2023 in the US) has created a biosimilar market that affects pricing and, consequently, development priorities. Reimbursement dynamics—particularly the shift toward value-based contracts and site-of-care payment reform—have made the FDA's expedited pathways more attractive, as faster approval translates to earlier revenue generation.

Conversely, market failures can suppress approval rates in specific categories. The 2004 withdrawal of natalizumab (Tysabri) due to progressive multifocal leukoencephalopathy (PML) cases temporarily chilled development of integrin-targeting agents. The 2021–2022 scrutiny of accelerated approvals in oncology, following confirmatory trial failures (e.g., bevacizumab in breast cancer), has made sponsors more cautious about surrogate endpoints.

Data Sources and Methods for Tracking Approvals

FDA Databases and Resources

The primary sources for FDA biologic approval data are:

1. The Purple Book: The FDA's official database of licensed biological products, including both reference products and biosimilars. It lists product name, licensure date, and whether the product is interchangeable. The Purple Book is searchable online and downloadable.

1. FDA Novel Drug Approvals page: Published annually, this lists new molecular entities (NMEs) and new biologics approved by CDER (Center for Drug Evaluation and Research). Note that therapeutic biologics are regulated by CDER, while vaccines, blood products, and gene therapies are regulated by CBER (Center for Biologics Evaluation and Research). The FDA's "Novel Drug Approvals" list covers CDER-regulated products only.

1. CBER Approved Products page: Lists vaccines, allergenic products, blood derivatives, and gene/cell therapies approved by CBER.

1. Drugs@FDA: The comprehensive database of all approved drug and biologic products, including labels, review documents, and approval letters.

1. FDA's Biological License Application (BLA) Approvals by Month: A monthly summary table that is useful for tracking approvals in near-real-time.

For a practical guide to the BLA process and data, see Biologics Development.

Analyzing Approval Trends

When analyzing approval-by-year data, a rigorous approach involves several steps:

1. Define the scope: Decide whether you are counting new BLAs, supplemental BLAs (sBLAs) for new indications, biosimilars, or all of the above. These are very different numbers.

1. Normalize by regulatory center: Separate CDER-regulated therapeutic biologics from CBER-regulated vaccines and gene therapies. Mixing them conflates different development timelines and regulatory standards.

1. Account for review timeline: The approval year reflects the date of FDA decision, not the date of submission. A surge in approvals in a given year may reflect a backlog of submissions from prior years.

1. Track withdrawals: Products can be withdrawn for safety or commercial reasons. A year with 50 approvals and 5 withdrawals has a different net effect than one with 50 approvals and no withdrawals.

1. Use rolling averages: Year-to-year fluctuations are noisy. A 3-year or 5-year rolling average provides a more stable trend line for strategic planning.

Common Pitfalls in Interpreting Approval Data

Distinguishing New Biologics from Biosimilars

The most common error in analyzing approval-by-year data is conflating biosimilars with new biologics. A biosimilar approval represents a market entry for an existing molecule, not a new therapeutic entity. The scientific and commercial implications are entirely different: a new biologic expands the therapeutic armamentarium, while a biosimilar increases competition and lowers price.

When reading industry reports, check whether the count includes biosimilars. The FDA's "novel drug approvals" list excludes them; the Purple Book includes them. If you are benchmarking your pipeline against historical approval rates, use new biologic counts only.

Accounting for Withdrawals and Indication Changes

Approval data is a snapshot at a point in time. Products approved in year X may be withdrawn in year Y, either voluntarily (commercial reasons) or at FDA request (safety reasons). Notable examples include:

• Bevacizumab in breast cancer: Accelerated approval was withdrawn in 2011 after confirmatory trials failed to show benefit.
• Alosetron (Lotronex): Withdrawn in 2000, then re-approved with restricted distribution in 2002.
• Daclizumab (Zinbryta): Withdrawn globally in 2018 due to inflammatory brain disease risk.

Additionally, a single biologic may receive multiple supplemental approvals for new indications in different years. Counting sBLAs as "approvals" inflates the number of new products. For example, pembrolizumab has received dozens of sBLA approvals across different cancer types; counting these as separate approvals would suggest far more new biologics than actually exist.

Ignoring the Modality Mix

A year with 40 approvals that are all monoclonal antibodies is scientifically different from a year with 20 mAbs, 10 gene therapies, and 10 cell therapies. The modality mix matters for competitive intelligence. If you are evaluating whether to invest in cell therapy manufacturing capacity, the relevant data point is not total biologic approvals but the trend in cell therapy approvals specifically.

Practical Summary and Strategic Implications

Key Takeaways

• Biologic approvals have grown from single digits per year in the 1980s to 40–50+ per year in the 2020s, driven by platform maturation, regulatory reform, and expanded therapeutic targets.
• Monoclonal antibodies remain the dominant modality, but the portfolio is diversifying into bispecifics, ADCs, gene therapies, and cell therapies.
• Oncology and immunology account for the majority of approvals, but rare disease and gene therapy approvals are growing fastest.
• Biosimilars are a separate category and should not be conflated with new biologics in trend analysis.
• The FDA's expedited programs materially accelerate approval timelines, making year-by-year counts sensitive to regulatory policy changes.
• Approval data must be interpreted with attention to withdrawals, indication expansions, and regulatory center (CDER vs. CBER).

Applying the Data in Industry

For a working scientist, the practical applications of approval-by-year data include:

• Portfolio benchmarking: Compare your organization's approval rate (by year and therapeutic area) against the industry average. If your company approved 2 biologics in 2023 while the industry approved 50, your yield is below average—prompting questions about pipeline quality or regulatory strategy.

• Resource planning: Approval trends inform hiring and capacity decisions. If gene therapy approvals are accelerating, investing in AAV manufacturing expertise may be prudent. See Biologics Regulatory Affairs Course for training options.

• Competitive intelligence: Tracking approvals by year and modality reveals which competitors are succeeding in which spaces. A competitor with three approved bispecifics in two years has a validated platform; one with zero approvals despite heavy investment may be struggling.

• Regulatory strategy: Understanding the FDA's current approval patterns—including the use of accelerated approval and breakthrough therapy designations—helps set realistic timelines for your own programs.

Frequently Asked Questions

How many biologics did the FDA approve in 2023?

In 2023, the FDA's Center for Drug Evaluation and Research (CDER) approved 55 novel drugs, of which approximately 20 were new biologics (the exact count depends on classification of novel modalities). The Center for Biologics Evaluation and Research (CBER) additionally approved several gene therapies and vaccines. The precise number varies by source because of differences in how "biologic" is defined and whether biosimilars are included.

What is the difference between a biologic and a small molecule drug?

A biologic is a therapeutic product derived from living systems—proteins, antibodies, nucleic acids, or cells—typically with molecular weights in the kilodalton range. A small molecule drug is a chemically synthesized compound, typically under 1000 Da. Biologics are regulated under the PHS Act (BLA pathway), while small molecules are regulated under the FD&C Act (NDA pathway). Biologics are generally administered by injection or infusion, are more immunogenic, and are more sensitive to manufacturing process changes.

Where can I find a list of FDA approved biologics by year?

The FDA's Purple Book is the authoritative database for licensed biological products, searchable by product name, licensure date, and biosimilar status. The FDA's "Novel Drug Approvals" annual summaries list new CDER-regulated biologics. CBER maintains a separate list of approved products, including vaccines and gene therapies. Drugs@FDA provides comprehensive approval history, including labels and review documents.

What is a BLA and how does it differ from an NDA?

A Biologics License Application (BLA) is the submission for approval of a biologic under Section 351 of the PHS Act. It must demonstrate safety, purity, and potency. A New Drug Application (NDA) is the submission for a small molecule drug under the FD&C Act, requiring demonstration of safety and effectiveness. The BLA places greater emphasis on manufacturing process characterization, facility inspection, and viral safety.

Why are there more biologic approvals now than in the past?

Multiple factors contribute: maturation of recombinant protein and antibody platforms, expansion into new therapeutic areas (oncology, rare disease, gene therapy), regulatory reforms that accelerated review timelines, and increased industry investment driven by the commercial success of biologics. The number of biologic approvals has grown from single digits per year in the 1980s to 40–50+ per year in the 2020s.

What are biosimilars and how are they counted in approval data?

Biosimilars are biological products highly similar to an approved reference biologic, with no clinically meaningful differences. They are approved under the abbreviated 351(k) pathway. In approval-by-year data, biosimilars are typically counted separately from new biologics. A year with many biosimilar approvals but few new biologics indicates market competition, not therapeutic innovation.

How does the FDA's expedited review process affect approval timelines?

The FDA's expedited programs—Fast Track, Breakthrough Therapy, Accelerated Approval, and Priority Review—can reduce development and review timelines substantially. Priority Review shortens the FDA review clock from 10 months to 6 months. Breakthrough Therapy designation provides intensive FDA guidance and rolling review. Accelerated Approval allows approval based on surrogate endpoints, with confirmatory trials required post-approval. These programs have compressed the overall timeline from first-in-human to approval from 10–12 years to as little as 5–7 years for qualifying products.

Key Takeaways

• Biologic approvals have grown from single digits per year in the 1980s to 40–50+ per year in the 2020s, driven by platform maturation, regulatory reform, and expanded therapeutic targets.
• Monoclonal antibodies remain the dominant modality, but the portfolio is diversifying into bispecifics, ADCs, gene therapies, and cell therapies.
• Oncology and immunology account for the majority of approvals, but rare disease and gene therapy approvals are growing fastest.
• Biosimilars are a separate category and should not be conflated with new biologics in trend analysis.
• The FDA's expedited programs materially accelerate approval timelines, making year-by-year counts sensitive to regulatory policy changes.
• Approval data must be interpreted with attention to withdrawals, indication expansions, and regulatory center (CDER vs. CBER).
• For industry scientists, approval-by-year data is a practical tool for portfolio benchmarking, resource planning, competitive intelligence, and regulatory strategy.

Further Reading

• Purpura CA et al. The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications. Clinical pharmacology and therapeutics. 2022. PubMed 34726771
• Papapetropoulos A et al. Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review. British journal of pharmacology. 2026. PubMed 41771767
• Kayki-Mutlu G et al. A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2022. Naunyn-Schmiedeberg's archives of pharmacology. 2023. PubMed 36951997

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