LG Chem joins in the 3-way race in Humira biosimilar mkt

Biosimilars account for 15% of the Humira market

LG Chem’s Humira biosimilar, Xelenka, is approved...3rd company to receive approval after Samsung and Celltrion

Biosimilar’s share in Humira market in Q3 reaches 15%...original drug still exerts a strong influence over the market

Humira’s drug price was reduced with the release of biosimilars… contributed to NHI financial savings

LG Chem has joined in to compete for a share of the Humira biosimilar market.

 

Humira is an original autoimmune disease treatment.

 

With the introduction, a three-way competition will start between Samsung Bioepis, Celltrion, and LG Chem in the KRW 100 billion annual market.

 

It has been 2 years since biosimilars entered the Humira market, but the original product still has a stronghold and remains unrivaled in the market.

 

LG Chem announced on the 15th that it has received marketing authorization from the Ministry of Food and Drug Safety for its adalimumab Humira biosimilar Xelenka.

 

Two types of Xelenka - Xelenka Prefilled Syringe Inj and Xelenka Autoinjector Inj – were approved at the time.

 

Xelenka is approved for the following adult indications: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, adult Crohn's disease, psoriasis, ulcerative colitis, Behcet's enteritis, hidradenitis suppurativa, and uveitis.

 

It is also approved for 3 pediatric indications: pediatric Crohn's disease (6 to 17 years of age), pediatric idiopathic arthritis, and pediatric plaque psoriasis.

 

As a result, three domestic companies, with LG Chem following Samsung Bioepis and Celltrion, have released Humira biosimilars in the market.

 

In July 2020, Samsung Bioepis received approval for Adalloce, the first Humira biosimilar, followed by the approval of Celltrion’s Yuflyma in June 2021.

 

Humira posted sales of KRW 104 billion in 2019 and KRW 91.2 billion and 85.8 billion in 2021 and last year, respectively.

 

Quarterly saels of Humira (Unit: 100 million, Data: IQIVA).

Competition in the Humira biosimilar market started in earnest when Samsung Bioepis’s Adalloce was approved with reimbursement in May 2021.

 

Although 2 years have passed since domestic companies started selling Humira biosimilars, the pace of expansions made by the biosimilars has been deemed to be slow..

 

According to the market research institution IQVIA, the market for adalimumab reached KRW 25.3 billion in Q3.

 

This is a 3.7% YoY increase and a 17.6% rise 2 years from the KRW 21.5 billion in Q3 2021.

 

The original Humira has maintained a solid stronghold over the market despite the entry of its biosimilar.

 

Humira's Q3 sales decreased 2.3% YoY to KRW 21.5 billion.

 

This is still a 1.8% rise from the KRW 21.1 billion it had raised in Q3 2021.

 

Adalloce’s Q3 sales were KRW 3.4 billion.

 

This was a 54.5% increase from Q3 last year and a 13.3% share of the adalimumab market.

 

Yuflyma’s Q3 sales reached KRW 400 million.

 

The market share of the two domestic biosimilars combined was 14.9% in Q3.

 

The share of biosimilars in the Humira market has been gradually expanding after exceeding 10% in Q4 last year, but the sales gap with the original product remains large.

 

Experts have attributed the slow market penetration rate to the small gap in the prices of original products and biosimilars.

 

The insurance ceiling price of Adalloce Prefilled Syringe 40mg/0.4ml and Yuflyma Pen 40mg/0.4ml are KRW 248,877 each, which is only a 15.0% difference from the price of Humira Prefilled Syringe 40mg/0.4ml and Humira Pen 40mg/0.4ml, which are set at KRW 288,091.

 

In principle, under the Korean drug pricing system, biosimilars can receive insurance prices up to 70% of the original drug price that was set before patent expiry.

 

Since October 2016, the price of ‘items developed by innovative pharmaceutical companies, or are equivalent, or those developed by domestic pharmaceutical companies in partnership with foreign companies, or items for which Korea grants first approval, or items produced domestically’ are set up to 80% of the original drug’s price.

 

The price of original drugs whose patents have expired is automatically reduced to 70-80% of its previous level upon the introduction of its biosimilars.

 

Even if a biosimilar is listed at a price 30% or more lower than the original drug's pre-patent expiry price, as the original drug's price is reduced at the same time, it is difficult for the generic company to secure price competitiveness.

 

Some analysts believe that in the field of autoimmune diseases, as drugs are used to treat severe illnesses, doctors and patients may prefer new drugs from multinational pharmaceutical companies that have accumulated trust over time if there is not much difference in drug prices.

 

However, biosimilars are known to contribute to financial savings for national health insurance by lowering the price of original drugs.

 

As of June 7, 2021, the insurance ceiling price of Humira has been reduced by 30% from the previous price.

 

The price of 3 drugs, Humira Pen Inj 40mg/0.4mL, Humira Prefilled Syringe Inj 40mg/0.4mL, and Humira Inj 40mg Vial, were cut 30% from KRW 415,058 to KRW 280,891, and the price of Humira Prefilled Syringe Inj 20mg/0.2mL was cut from KRW 224,002 to KRW 156,801.

 

Humira recorded sales of 27.5 billion won in Q1 2021, but sales had fallen 24.9% the next quarter to 20.7 billion won due to price cuts.