US welcomes Idacio and Hulio to Adalimumab biosimilars market

The US biosimilars market gains 2 more adalimumab products: Idacio by Fresenius Kabi (adalimumab-aacf) and Hulio by Biocon Biologic (adalimumab-fkjp).

Both Idacio and Hulio refer to Humira (adalimumab), one of the most profitable drugs in the world. Throughout July 2023, 8 biosimilars of adalimumab are planned to be launched in the United States.

The launches of these 2 products come after 5 adalimumab biosimilars entered the US market over the 4th of July weekend. Boehringer Ingelheims Cyltezo (adalimumab-adbm), Coherus Biosciences Yusimry (adalimumab-aqvh), Samsung Bioepis’ Organon and Hadlima (adalimumab-bwwd), and Sandoz’ Hyrimoz (adalimumab-adaz) were launched on July 1. Celltrion’s Yuflyma (adalimumab-aaty) was launched on July 2. Amjevita (adalimumab-act), developed by Amgen, also launched in January 2023.

Adalimumab products are used to treat a number of rheumatic and immunological diseases.

This is the Idacio adalimumab biosimilar autojector and the packaging it comes in.

The launch of Idacio

Fresenius Kabi has launched Idacio, its first immunological biosimilar. It is a low concentration product, without citrate. FDA approval for 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 pre-filled syringe and a self-administered pre-filled pen (auto-injector).

We are excited to launch Idacio, our first immunology biosimilar in the United States, said Ali Ahmed, senior vice president, Biosimilars at Fresenius Kabi USA. Our biosimilar adalimumab is part of a dedicated pipeline of high-quality, affordable immunological biosimilars from Fresenius Kabi aimed at improving 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’s disease, adult ulcerative colitis and plaque psoriasis.

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

Hulio and the transfer of the Biocon Biologics/Viatris portfolio

This is the Hulio adalimumab biosimilar autojector pen.

Hulio is a low-strength adalimumab product that is citrate-free and helps reduce pain at the injection site during administration. It does not have an interchangeability designation and Biocon Biologics has not indicated that it will seek the label.

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

“Biocon Biologics is pleased to make Hulio, an easy-to-use, 2-click prefilled pen available in the United States for patients with select inflammatory diseases,” said Mathew Erick, chief commercial officer of advanced markets at Biocon Biologics, in a declaration. “There are no buttons to push. Patients remove the cap and push the device against their skin to trigger the injection. Designed and built with patients in mind, healthcare professionals and patients shouldn’t miss a beat with Hulio; Click, Go .'”

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

The bulk purchase cost of the branded product is 5% less than Humira’s current list price. Biocon Biologics also offers an unbranded option of the same drug that’s priced 85 percent 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 benefit verification and prior authorization support, copay assistance, a bridging program, and home nursing injection training.

The biologics license application for the product was filed by Viatris but is now fully under the control of Biocon Biologics after the successor company acquired the former’s entire biosimilars 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 its acquired biosimilars business in more than 70 villages.

Viatris and Biocon Biologics said they will continue to work together over the next few years to ensure a smooth transition. As part of the agreement, Viatris will receive upfront payments of $2.3 billion and mandatorily convertible preferred stock in Biocon Biologics, valued at $1 billion.

“This will enable Biocon Biologics to significantly expand the geographic reach of the current biosimilars portfolio and future pipeline in growth markets where Viatris has existing sales infrastructure and local market expertise,” commented Susheel Umesh, director Biocon Biologics’ emerging markets business, in a statement on the completed integration. “Working closely with key stakeholders in these markets will enable us to ensure reliable supplies of our biosimilars to those who need them most, while enabling us to tap into the rapidly expanding global biosimilars opportunity.”

Pfizer’s Abridlada (adalimumab-afzb) is the latest biosimilar scheduled for launch in July 2023.

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