With FDA nod, Samsung Bioepis joins Celltrion in unbranded Humira biosimilar push against AbbVie

Samsung Bioepis is tightening its grip on the U.S. biosimilar market with FDA approval to sell an unbranded version of Hadlima (adalimumab), its biosimilar to AbbVie's blockbuster Humira. 

The move signals a shift in its commercialization strategy as the Korean biosimilar giant ramps up price-driven competition while advancing a parallel bid in the PD-1 race with a Keytruda (pembrolizumab) biosimilar.

The FDA cleared the label change on Monday (U.S. time) through a supplemental biologics license application, allowing Samsung Bioepis to market adalimumab-bwwd -- the same formulation as Hadlima -- under a non-branded name. 

The company did not disclose the price but confirmed the unbranded product would be sold at a lower cost.

This is Samsung Bioepis’ first time offering both branded and unbranded versions of the same biosimilar in the U.S., a move lifted straight from Celltrion’s playbook.

In November 2023, Celltrion received FDA approval to market its Humira biosimilar Yuflyma with unbranded biological product labeling under the name adalimumab-aaty.

That version has since secured full interchangeability with Humira across all presentations, including syringes and autoinjectors.

Now, Bioepis is following suit.

Unbranded biosimilars, often deployed as pricing levers in negotiations with PBMs and institutional buyers, are especially attractive in Medicaid and hospital tenders, where formulary status frequently hinges on cost. 

In the U.S. prescribing system, where many prescriptions are written by drug substance rather than brand, dropping the name can offer a strategic advantage.

“Pharmacies can substitute Hadlima for the reference product Humira without consulting prescribers,” said Jon Martin, U.S. commercial lead for biosimilars at partner company Organon, when the branded version received its own interchangeability designation last month. 

The move, he added, could “facilitate increased access for patients to receive the medications they need,” noting that out-of-pocket costs for Humira were more than "four times" higher than those for Hadlima on average.

According to Organon, Hadlima -- priced around $1,038 -- is 85 percent cheaper than Humira, which remains listed at roughly $6,922.62 as of October 2023. 

That mirrors Celltrion’s bifurcated pricing model for Yuflyma, which offers an 85 percent discount on the unbranded version and a more modest 5 percent cut on the branded option. The FDA has now designated Hadlima as fully interchangeable with Humira across both low- and high-concentration formulations and all delivery devices.

The milestone came after Bioepis and Organon expanded Hadlima’s label in May this year to include high-concentration autoinjectors and prefilled syringes, capping off a stepwise rollout that began with low-concentration vials in June 2024.

Hadlima entered the U.S. market in July 2023 following a long-delayed launch tied to patent settlements with Humira’s originator, AbbVie. Amgen’s Amjevita, the first Humira biosimilar to launch, preceded it by six months.

While Samsung Bioepis accelerates a global dual-track clinical strategy for its Keytruda biosimilar by conducting phase 1 and phase 3 studies in parallel, it is now applying a similar dual-track commercial playbook to Humira by targeting both price-sensitive institutional channels and brand-loyal retail markets.