Competition in full swing for the ₩100 bil Humira mkt

with introduction of biosimilars in Korea

Celltrion’s ‘Yuflyma’ reimbursed form March… the second biosimilar to be approved after Samsung-Yuhan’s ‘Adalloce’

Insurance price cap set at ₩244,877, same as Adalloce… Will Humira be able to defend the market with its 30% discounted price?

Competition in the domestic Humira biosimilar market is expected to unfold with Celltrion's entry into the market.

 

On how the market that was once dominated by its only biosimilar option, Samsung Bioepis’ Adalloce, will change with the entry of Celltrion in the market, remains the focus of attention.

 

Humira, which is mainly used to treat rheumatoid arthritis, has formed a market worth ₩100 billion in Korea.

 

Celltrion’s Humira (Abbvie, adalimumab) biosimilar ‘Yuflyma pen injection 40mg/0.4mL)’ will be reimbursed from March 1st.

 

Its insurance price cap was set at ₩244,877, identical to Samsung Bioepis’s ‘Adalloce.’ As the price ceiling for the original drug, Abbvie’s ‘Humira,’ was set at ₩288,091, the price difference between the three products is not large.

 

Humira recorded $20.69 billion (₩24 .8 trillion) in global sales in 2021 and has maintained the lead in pharmaceutical sales for 10 consecutive years since 2012.

 

According to IQVIA, the drug also boasted much use in Korea, recording ₩91.2 billion in sales in 2021.

 

This is a drop from the ₩104 billion sold in 2020, but the decrease was inevitable as Humira’s price cap was reduced by 30% with the approval of Adalloce.

 

Humira is a monoclonal antibody drug that is used to treat various conditions.

 

In addition to rheumatoid arthritis, Humira is indicated for the treatment of psoriasis arthritis, axial spondyloarthritis, adult and pediatric Crohn's disease, psoriasis, ulcerative colitis, Behcet’s disease, hidradenitis suppurativa, uveitis, pediatric idiopathic arthritis, and pediatric plaque psoriasis.

 

With the rapid entry of Humira biosimilars, the industry expects Humira to encounter a crisis within the next two years.

 

In particular, K-biosimilars are emerging as a vanguard that may break down the stronghold held by Humira.

 

Samsung Bioepis launched a Humira biosimilar in the European market in 2018 and has been competing for the first and second place in the biosimilar market ever since.

 

Celltrion is also busy tackling the European market based on the approval it received last year.

 

In 2023, K-biosimilars’ entry into the Humira market is expected to increase further with Humira’s patent expiry in 2023.

 

Pic of Humira and Adalloce

In Korea, Samsung Bioepis received reimbursement approval for its ‘Adalloce’ in April last year and released the product.

 

Yuhan Corp, which has a large distribution network, is in charge of its marketing and sales of Adalloce.

 

With the introduction of Adalloce, Humira’s drug price had also been discounted 30%, and therefore may not be able to guarantee its annual sales of ₩100 billion this year.

 

In the meantime, competition between AbbVie, which wishes to maintain its market share, and the biosimilar companies Samsung Bioepis and Celltrion is expected to further accelerate with the reimbursement approval granted for Celltrion.

 

Due to the conservative characteristic of the Korean market, generics or biosimilars generally have difficulty penetrating the Korean market.

 

In particular, latecomers of injections that are administered in general hospitals like Humira have more difficulty entering the market.

 

However, as Celltrion’s Remicade biosimilar ‘Remsima’ successfully penetrated the market and earned ₩20 billion in Korea, attention is focused on whether Humira’s biosimilar may also perform this ‘K-magic.’