Upcoming 'Humira Biosimilar Battle'... Concentration and Manufacturing Site Are Key

World's Highest-Grossing Mega Blockbuster
Market Dominance Keyword: 'Concentration'

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The US biosimilar (biopharmaceutical) market for Humira (active ingredient adalimumab), valued at 25 trillion won, is set to open this July, and developers are rushing to finalize preparations for its launch. Some are preparing to increase the concentration to strengthen market dominance, while others are making efforts to overcome the last hurdles before approval.

AbbVie's immunemediated disease treatment 'Humira (active ingredient Adalimumab)'

According to AbbVie, the developer, Humira, an immunemediated disease treatment, recorded sales of $21.237 billion (approximately 28 trillion won) last year. Although it lost its throne to Pfizer's COVID-19 vaccine Comirnaty during the COVID-19 pandemic, it had firmly held the world's top sales spot for over a decade as a blockbuster drug. It is used to treat immune-mediated diseases such as rheumatoid arthritis, Crohn's disease, and plaque psoriasis.

However, recent sales of Humira in Europe have plummeted. As biosimilars have been launched one after another, its market share has been halved, and last year's sales dropped by 22.2% year-on-year to $2.618 billion (approximately 3.4558 trillion won). On the other hand, US sales, where biosimilars have not yet been launched, grew by 7.4% year-on-year to $18.619 billion (approximately 24.5771 trillion won). However, since biosimilar developers who have reached patent agreements with AbbVie are expected to competitively launch products starting this year, US sales are also feared to decline sharply.

Most of the agreements are aligned with the July launch, marking the start of a full-scale battle, with drug concentration considered a key factor determining success. Humira is divided into a high-concentration formulation (HCF) of 100 mg/mL and a low-concentration formulation of 50 mg/mL. Although there is still demand for the low-concentration product, preference is higher for the HCF, which reduces the drug dosage by increasing concentration. It is known that over 80% of Humira prescriptions in the US are for the HCF.

This preference is analyzed as the reason why Amgen, which first launched Amjevita in January to capture the market, has yet to achieve significant results. According to Samsung Securities, Amjevita's market share in the US was only 0.2% as of last month. Amgen has only completed development of the low-concentration formulation. The HCF is undergoing Phase 3 clinical trials and is planned to be launched next year.

Currently, there are four developers who have either received approval for the HCF or are in the final stages of approval. Samsung Bioepis and Sandoz have already received US FDA approval for the HCF. Samsung Bioepis obtained FDA approval for the HCF of Hadlima, the first biosimilar to do so, in August last year. They plan to capture both markets by launching the previously approved low-concentration formulation as well. Sandoz, which plans to launch Hyrimoz, also succeeded in obtaining HCF approval last month following the low-concentration formulation, emerging as Samsung Bioepis's biggest competitor. Notably, they advanced their agreed launch date from September to July 1, intensifying their market push.

Unlike these two companies, Celltrion and Alvotech, which developed only the HCF from the start, have not yet received approval and are rushing through final procedures such as FDA inspections. However, while Alvotech is at risk of stumbling due to manufacturing site issues, Celltrion is quickly overcoming obstacles and approaching the starting line of the race.

Alvotech, developing Hukyndra (AVT-02), was expected to receive approval around the 13th but instead received a Complete Response Letter (CRL) from the FDA on that day. Defects were found at the production facility located in Reykjavik, Iceland. This is the second time Alvotech has encountered such a setback, having received a CRL during an FDA inspection last September. However, Alvotech plans to resolve this quickly and obtain approval for Hukyndra by the end of June to align with the July launch.

Celltrion's Uplyma (CT-P17) faced similar issues but has already overcome them. Uplyma, which is already sold in Europe and Korea but has not yet received FDA approval, was cited for issues with its overseas manufacturing site during an FDA inspection in February. However, Celltrion states that all these issues have been resolved. It has already received a Voluntary Action Indicated (VAI) rating from the FDA, which is given when violations are not considered serious, and is continuing discussions with the FDA aiming for approval next month.

This content was produced with the assistance of AI translation services.