Drug Update · Pharmacology

FDA Lists Multiple 2025–2026 Biosimilar Approvals, Including Rituximab and Insulin Aspart

August 17, 2026

PMDA approved biosimilars (as of March 2024)

35 biosimilars across 18 active pharmaceutical ingredients

Zimrixby (rituximab-cdxx) FDA listing

July 2026

Garzulys (insulin aspart-fsan) FDA listing

July 2026

Wezlana (ustekinumab-auub) interchangeable approval

October 31, 2023

HADLIMA initial U.S. approval (per label)

2019

IDACIO FDA original approval date

2022-12-13

Clinical Perspective

Health care professionals and pharmacists caring for patients treated for inflammatory diseases, rheumatologic conditions, oncology-support indications, and diabetes/insulin-requiring patients should be aware of the expanding listing of FDA-approved biosimilars and related prescribing information ^[6]^[5]^[2]. The FDA product listings and labeling resources support clinicians in identifying approved biosimilars, their reference products, and labeled indications, and FDA guidance clarifies that interchangeability determinations can permit pharmacy-level substitution depending on state substitution laws ^[5]^[8]^[7]. How will pharmacy-level substitution laws and institution-level policies shape real-world interchangeability and substitution for newly listed biosimilars such as rituximab and insulin aspart biosimilars?

Dr. Pooja Sinha, MBBS, MD (General Medicine), MRCP · General Medicine

The FDA’s Biosimilar Product Information page lists multiple biosimilar approvals across 2024–2026, including Zimrixby (rituximab-cdxx) and Garzulys (insulin aspart-fsan) with July 2026 approval entries, and numerous pegfilgrastim, ranibizumab, denosumab, and other biosimilars ^[5]. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) created a biosimilars web page in FY 2023 and reported that as of March 2024, 35 biosimilars were approved in Japan across 18 active pharmaceutical ingredients, including adalimumab and rituximab ^[1]. These sources provide regulatory listings, product names, and prescribing information links for multiple marketed biosimilars ^[5]^[1].

Clinical Context

The FDA defines biosimilars as biological products that are highly similar to a reference product with no clinically meaningful differences in safety, purity, or potency, and describes that interchangeable biosimilars meet additional statutory requirements that may permit pharmacy-level substitution depending on state laws ^[8]. FDA’s Biosimilar Product Information page lists individual biosimilar approvals with the biosimilar name, approval date, and reference product (for example, Zimrixby — rituximab — July 2026; Garzulys — insulin aspart — July 2026) ^[5]. FDA also provides guidance and resources for industry and labeling recommendations for biosimilar and interchangeable products ^[7]. National regulatory bodies have worked to centralize biosimilar information: the PMDA launched a biosimilars web page in FY 2023 and summarized approvals and educational materials to support healthcare providers and patients ^[1]. Multiple adalimumab biosimilars have full prescribing information accessible via DailyMed, listing indications and dosing that mirror reference-product labeling across immunologic and gastroenterologic indications ^[2]^[3]^[4]^[9]^[10]^[11].

Key Findings

The FDA Biosimilar Product Information page lists Zimrixby (rituximab-cdxx) with an approval entry of July 2026 and Garzulys (insulin aspart-fsan) with an approval entry of July 2026, among other approvals spanning 2024–2026 ^[5].
The FDA has previously approved at least one biosimilar determined to be interchangeable (Wezlana [ustekinumab-auub] was approved as biosimilar and interchangeable with Stelara on October 31, 2023) and describes the data types used to support interchangeability determinations, including analytical comparisons, human pharmacokinetic data, and comparative clinical immunogenicity and safety data ^[6].
Product-specific prescribing information for multiple adalimumab biosimilars (examples: HADLIMA, HYRIMOZ, CYLTEZO, IDACIO, Adalimumab-adaz, Adalimumab-aacf) list the same categories of labeled indications — rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis — reflecting approved reference-product indications documented in DailyMed entries ^[2]^[4]^[9]^[10]^[11].
Japan’s PMDA reported that, as of March 2024, 35 biosimilars were approved in Japan covering 18 active pharmaceutical ingredients spanning nine disease-area patterns including rheumatology and oncology, and the PMDA site provides definitions, approved products, and related guidelines ^[1].

Safety & Tolerability

Serious infections including tuberculosis (TB), bacterial sepsis, and invasive fungal infections have been reported with adalimumab products and are included in boxed warnings across multiple adalimumab biosimilar labels; clinicians are advised to discontinue therapy if a serious infection develops and to test for latent TB prior to initiation ^[2]^[3]^[4]^[9]^[10]^[11].
Malignancy risks, including reports of lymphoma and post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), are described in adalimumab biosimilar labeling ^[2]^[4]^[9]^[10]^[11].
Common adverse reactions reported (>10%) in adalimumab biosimilar labeling include infections (e.g., upper respiratory infections, sinusitis), injection site reactions, headache, and rash ^[2]^[4]^[9]^[10]^[11].
Additional labeled risks across adalimumab biosimilar prescribing information include anaphylaxis or serious hypersensitivity reactions, hepatitis B virus reactivation, demyelinating disease (exacerbation or new onset), cytopenias/pancytopenia, heart failure worsening or new onset, and lupus-like syndrome or autoimmune hepatitis ^[2]^[4]^[9]^[10]^[11].
For interchangeable ustekinumab biosimilar Wezlana, the most serious known side effect noted is infection; the label also lists common adverse reactions such as nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, and others ^[6].

Study Design

This is a regulatory and product-information update based on FDA’s Biosimilar Product Information listings and associated prescribing information and on national regulatory reporting from Japan’s PMDA. The FDA listings present product name, approval month/year, and reference product for each biosimilar entry (for example, Zimrixby — rituximab — July 2026; Garzulys — insulin aspart — July 2026) ^[5]. For clinical-trial evidence cited in product labeling, the IDACIO (adalimumab-aacf) prescribing information describes randomized, double-blind studies in rheumatoid arthritis including Study RA-II (monotherapy) and Study RA-III (methotrexate combination) with ACR response results reported at 24–52 weeks, as presented in the label ^[12]. Other DailyMed labels provide full prescribing information with study descriptions, and further design details are available within each product’s prescribing information ^[2]^[4]^[9]^[10]^[11].

FAQ

What is the drug approved for?

The recent FDA biosimilar product listings include named biosimilars and their reference products; examples in the FDA list include Zimrixby (rituximab-cdxx) and Garzulys (insulin aspart-fsan) with July 2026 entries. Multiple adalimumab biosimilars have U.S. prescribing information listing indications that align with the reference-product adalimumab across rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. The PMDA also reports approved biosimilars and educational materials on its biosimilars web page.

How does it work?

Each biosimilar is developed to be highly similar to its FDA-approved reference product; for example, adalimumab biosimilars bind to tumor necrosis factor-alpha (TNF‑alpha) consistent with adalimumab’s mechanism described in prescribing information. FDA guidance explains that biosimilars are expected to have no clinically meaningful differences in safety, purity, or potency compared to the reference product, and interchangeability determinations require additional evidence such as analytical similarity, pharmacokinetic comparisons, and clinical immunogenicity and safety data.

What is the dose?

Dosing is specified in each product’s prescribing information. For the class example of adalimumab products, recommended adult dosing listed in multiple DailyMed entries includes 40 mg subcutaneously every other week for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, with weight- and indication-specific induction and maintenance regimens for Crohn’s disease and ulcerative colitis as provided in the individual labels. Clinicians should consult current prescribing information for complete dosing guidance.

What are the side effects?

Product labeling for multiple biosimilars lists serious infections (including TB, bacterial sepsis, and invasive fungal infections) and malignancy risks such as lymphoma and, in post-marketing reports, hepatosplenic T-cell lymphoma. Common adverse reactions in adalimumab biosimilar labels include infections (upper respiratory, sinusitis), injection site reactions, headache, and rash. Additional labeled risks include anaphylaxis, hepatitis B reactivation, demyelinating disease, cytopenias, heart failure, and lupus-like syndromes. Clinicians should consult current prescribing information for complete dosing guidance.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Lists Multiple 2025–2026 Biosimilar Approvals, Including Rituximab and Insulin Aspart

Direct Clinical Takeaway & Evidence Summary

FDA Lists Multiple 2025–2026 Biosimilar Approvals, Including Rituximab and Insulin Aspart

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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