FDA Accepts Supplemental Biologics License Application for Hadlima for Interchangeability With Humira


The sBLA was based on data from a clinical study assessing the pharmacokinetics of switching between adalimumab and adalimumab-bwwd for patients with moderate to severe plaque psoriasis.

The FDA has accepted a supplemental Biologics License Application (sBLA) for review for adalimumab-bwwd (Hadlima; Samsung Bioepis Co Ltd, Organon & Co) injection 40 mg/0.4 mL as an interchangeability designation for adalimumab (Humira; AbbVie). In August 2023, Samsung Bioepis the sBLA was submitted to the FDA.1

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“Following our announcement on the interchangeability study’s topline results in August, we are excited to share the progress on this sBLA filing on interchangeability. This filing acceptance is a reinforcement of our commitment to provide better access to biologic medicines for patients in the United States,” Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, said in a press release.1

The sBLA was based on data from a phase 4 randomized, double-blinded clinical study (NCT05510063) designed to assess the pharmacokinetics between 2 treatment groups of patients with moderate to severe plaque psoriasis, switching between adalimumab and adalimumab-bwwd, and those receiving just adalimumab.1

The drug was first approved in July 2019 as a low-concentration formulation at 40 mg/0.8 mL in a prefilled syringe and prefilled autoinjector. The high concentration formulation at 40 mg/0.4 mL was also approved in August 2022, according to the press release. Adalimumab-bwwd was introduced into the commercial market in July 2023.1

Adalimumab-bwwd is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis.1

“An interchangeability designation may play a role beyond enabling pharmacy substitution. We believe that interchangeability could help increase physician confidence with prescribing biosimilars, especially in the high-concentration formulation which is used by the majority of patients [receiving adalimumab]. We remain committed to helping more patients access biosimilar alternatives,” Jon Martin, Head of US Biosimilars at Organon, said in the press release.1

Although there has been an increase in approved biosimilars reaching the market, there is still an ongoing debate about switching from a reference product to a biosimilar and vice versa.2

The interchangeability designation has been met with concern about the usage of biosimilars for pharmacy stakeholders being that the FDA is the only authority that can designate a biosimilar as interchangeable. In order for the designation to occur, the biosimilar has to have similar results for the same indication as the reference drug.2

In a session at the Academy of Managed Care Pharmacy Nexus 2023, presenter Jensen said that there is a need for further education on interchangeability for both patients and physicians. Many are hesitant to switch medications, but Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic said that switching does not have to do with the efficacy or safety of the biosimilar.2

Annie Schuster, PharmD, FAMCP, senior director of Clinical Pharmacy Programs at Cigna Healthcare added that there needs to be better conversations between prescribers and patients about the safety and efficacy of switching biosimilars, as well as any financial implications. She said that as prescribers gain more comfort with biosimilars, they will be able to assess and understand the cost of these drugs for patients.2


  1. Samsung Bioepis & Organon Announce FDA acceptance of supplemental biologics license application (sBLA) for interchangeability designation for Hadlima (adalimumab-bwwd), a Biosimilar to Humira. News release. Samsung Bioepis. November 7, 2023. Accessed November 8, 2023. https://finance.yahoo.com/news/samsung-bioepis-organon-announce-fda-211500723.html?guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAI7pbklXe1U1jv7mf7Okyi2fBhRPofXaWXydt2_PVmQd_GetClAwyG7UD4npvJ9PCNQHxo-4hx49at2xYUp8VfchRxlLl0ie96GuTyb6ch8qyBAYlcSd2sQPVF0EOROByDf0jDqotos2tH9qe3bOlVA2bF4sp8GNKKyqRm2u6o8S&guccounter=2
  2. Gallagher, A. Interchangeability designation still widely debated, prescribers hesitant about biosimilars. Pharmacy Times. October 19, 2023. Accessed November 8, 2023. https://www.pharmacytimes.com/view/interchangeability-designation-still-widely-debated-prescribers-hesitant-about-biosimilars
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