FDA approves Hadlima and Otulfi as interchangeable biosimilars

In May 2025, the US Food and Drug Administration (FDA) has designated Samsung Bioepis and Organon’s Hadlima (adalimumab-bwwd) autoinjectors and prefilled syringes as the fifth interchangeable Humira biosimilar. Separately, Formycon’s Otulfi (ustekinumab-aauz) became the fourth interchangeable Stelara biosimilar.

Hadlima (adalimumab-bwwd) biosimilar injection
On 27 May 2025, Samsung Bioepis and Organon announced that the FDA designated Hadlima (adalimumab-bwwd) autoinjectors (high/low-concentration: 40 mg/0.4 mL, 40 mg/0.8 mL) and a high-concentration prefilled syringe as interchangeable biosimilars to Humira (adalimumab).

This follows the June 2024 interchangeability designation for Hadlima’s low-concentration prefilled syringe and vial.

With these approvals, Hadlima is now interchangeable with all Humira presentations.

The designation was supported by a pharmacokinetic (PK), efficacy, safety, and immunogenicity study comparing SB5 (adalimumab biosimilar) to Humira in moderate-to-severe chronic plaque psoriasis patients. A randomized, double-blind trial assessed patients switching between EU-sourced Humira and high-concentration SB5 versus continuous Humira treatment. Results showed comparable PK endpoints, efficacy, safety, and immunogenicity. Additional studies further supported interchangeability for both low- and high-concentration autoinjectors.

Hadlima was first FDA-approved in 2019 as a low-concentration (40 mg/0.8 mL) prefilled syringe and autoinjector [1]. The high-concentration (40 mg/0.4 mL) formulation was approved in 2022. Both have been commercially available in the US since 2023.

Currently, there are 11 adalimumab biosimilars approved in the US, five of which have received interchangeability designation: Cyltezo, Abrilada, Hadlima, Simlandi, and Hyrimoz.

Otulfi(ustekinumab-aauz) biosimilar
On 19 May 2025, Formycon and its commercialization partner Fresenius Kabi announced that their Stelara biosimilar, Otulfi(ustekinumab-aauz), was granted interchangeability status by the US Food and Drug Administration (FDA). This comes just two months after the product launched in the US and Europe.

In the US, Otulfi/FYB202 is indicated for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. In the EU, Otulfi has been launched to treat moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis and active psoriatic arthritis.

Following approval, Fresenius Kabi launched the 45 mg and 90 mg single-dose prefilled syringe for injection as well as the 130 mg single dose vial presentations for IV infusion in the US and Europe.

As of 30 April 2025, Otulfi/FYB202 is interchangeable in all presentations matching the reference product.

The originator product is Johnson & Johnson’s (J&J) Stelara and the first interchangeable ustekinumab biosimilar product approved in the US was Wezlana [2].

To date, seven ustekinumab biosimilars have been approved in the US. Two of these—Otulfi (ustekinumab-aauz) and Wezlana (ustekinumab-auub)—have received interchangeability designation, while two others—Selarsdi (ustekinumab-aekn) and Pyzchiva (ustekinumab-ttwe)—have received provisional interchangeability determination.

An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws [3].

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Hadlima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 30]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-adalimumab-biosimilar-Hadlima
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable ustekinumab biosimilar Wezlana [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 30]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-ustekinumab-biosimilar-wezlana
3. GaBI Online - Generics and Biosimilars Initiative. FDA releases new information on interchangeable biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Jun 30]. Available from: www.gabionline.net/biosimilars/general/FDA-releases-new-information-on-interchangeable-biologicals

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