US Welcomes Idacio, Hulio to the Adalimumab Biosimilar Market

The US biosimilar market gains 2 additional adalimumab products: Fresenius Kabi's Idacio (adalimumab-aacf) and Biocon Biologic's Hulio (adalimumab-fkjp).

Both Idacio and Hulio reference Humira (adalimumab), one of the most profitable drugs in the world. Throughout July 2023, 8 adalimumab biosimilars are projected to launch in the United States.

The launches of these 2 products come after 5 adalimumab biosimilars entered the US market over the Fourth of July weekend. On July 1, Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), Coherus Biosciences’ Yusimry (adalimumab-aqvh), Organon and Samsung Bioepis' Hadlima (adalimumab-bwwd), and Sandoz' Hyrimoz (adalimumab-adaz) launched. On July 2, Celltrion's Yuflyma (adalimumab-aaty) launched. Amjevita (adalimumab-atto), developed by Amgen, also launched in January 2023.

Adalimumab products are used to treat a range of rheumatic and immunology diseases.

The Launch of Idacio

Fresenius Kabi launched Idacio, its first immunology biosimilar. It is a low-concentration, citrate-free product. FDA approval of Idacio was granted in December 2022, and the biosimilar will be used for 7 of the 11 indications of the reference product, Humira (adalimumab). It will be offered in a self-administered prefilled syringe and a self-administered pre-filled pen (autojector).

“We are thrilled to launch Idacio, our first immunology biosimilar in the U.S.,” said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. “Our adalimumab biosimilar forms part of a dedicated pipeline of affordable and high-quality immunology biosimilars from Fresenius Kabi, aimed to improve the quality of life of patients with chronic diseases,” according to the press release.

The Idacio branded biosimilar is offered in over 35 countries. It is indicated for decreasing signs and symptoms of diseases such as rheumatoid (RA), juvenile idiopathic arthritis, psoriatic arthritis (PsA), ankylosing spondylitis, Crohn disease, adult ulcerative colitis, and plaque psoriasis.

Earlier in 2023, Fresnius Kabi launched its first US biosimilar Stimufend (pegfilgrastim-fgpk), a pegfilgrastim biosimilar.

Hulio and the Biocon Biologics/Viatris Portfolio Transfer

Hulio is a low-concentration adalimumab product that is citrate-free, allowing for less injection site pain during administration. It does not have an interchangeability designation and the Biocon Biologics has not indicated that it will try to obtain the label.

The biosimilar is available in a prefilled syringe and autoinjector pen.

"Biocon Biologics is pleased to make Hulio, a patient-friendly, 2-click, prefilled pen available in the United States for patients with certain inflammatory diseases” said Mathew Erick, chief commercial officer of advanced markets at Biocon Biologics, in a statement. "There are no buttons to push. Patients remove the cap and push the device against their skin to trigger their injection. Designed and built with patients in mind, healthcare professionals and patients don’t have to miss a beat with Hulio; they simply, ‘Click, Click, Go.'"

The biosimilar was approved in July 2020. Hulio is indicated for RA, PsA, juvenile idopathic arthritis, ankyosing spondylitis, Crohn disease, and ulcerative colitis.

The wholesale acquisition cost of the branded product is 5% below the current list price for Humira. Biocon Biologics is also offering an unbranded option of the same drug that is priced 85% below Humira's list price, similar to Amgen's pricing strategy for Amjevita.

Biocon Biologics also offers HULIO360, the company's patient support program, which offers patients benefits verification and prior authorization support, copay assistance, a bridge program, and at-home nurse injection training.

The biologics license application for the product was submitted by Viatris but is now fully under the control of Biocon Biologics after the later company acquired the former's entire biosimilar portfolio.

Biocon Biologics’ acquisition of Viatris’ biosimilars was announced in March 2022, and the deal closed in November 2022. As of July 1, Biocon Biologics has completed the integration of the acquired biosimilars business in over 70 countries.

Viatris and Biocon Biologics have stated continue to work together over the next few years to ensure a smooth transition. As part of the agreement, Viatris will receive up-front payments of $2.3 billion and compulsorily convertible preference shares in Biocon Biologics, which are valued at $1 billion.

"This will allow Biocon Biologics to meaningfully expand the geographic reach of the existing biosimilars portfolio and future pipeline into growth markets where Viatris has existing sales infrastructure and local market expertise," commented Susheel Umesh, chief commercial officer of emerging markets at Biocon Biologics, in a statement on the completed integration. "Working closely with key stakeholders in these markets will allow us to ensure reliable supplies of our biosimilars for those who need them the most, while enabling us to capitalize on the rapidly expanding global biosimilars opportunity."

Abridlada (adalimumab-afzb) by Pfizer is the last biosimilar anticipated to launch in July 2023.