Capture the 6 trillion won market… ‘Cosentyx’ similar competition is on fire

(Health Korea News / Lee Chung-man) The competition to develop biosimilars targeting the market for Swiss Novartis’ autoimmune disease treatment drug ‘Cosentyx’ (ingredient name: secukinumab) is becoming increasingly fierce.

According to Health Korea News, there are a total of 8 biosimilars of ‘Cosentyx’ currently under development. Of these, 2 drugs are currently undergoing phase 3 clinical trials, and 1 drug is about to enter phase 3. The rest are being evaluated in phase 1 clinical trials or preclinical trials. (See chart below)

Among domestic companies, Celltrion is the only one developing a ‘Cosentyx’ biosimilar. Last month, Celltrion received approval for the global phase 3 clinical trial plan (IND) for ‘CT-P55’, a ‘Cosentyx’ biosimilar, from the U.S. Food and Drug Administration (FDA). In this global clinical trial, Celltrion plans to conduct a comparative study to prove the equivalence of efficacy and safety between the original drug and ‘CT-P55’ on a total of 375 patients with plaque psoriasis. (See related article below)

The development of ‘Cosentyx’ biosimilars is largely led by Chinese companies. Of the eight drugs in total, five, or 62.5%, are being developed by Chinese companies.

The most recent company to receive clinical trial approval is also from China. On the 18th (local time), China’s Gan & Lee Pharmaceuticals confirmed that it had received approval for a phase 1 clinical trial plan (IND) to evaluate its Cosentyx biosimilar, GLR-1023. The trial will evaluate the bioequivalence of GLR-1023 and Cosentyx on 160 healthy adult males in China.

The initial indications for the Cosentyx biosimilars currently in development are all geared toward the treatment of plaque psoriasis, but the companies are expected to gradually expand the indications once they receive approval.

(Current status of development of ‘Cosentyx’ biosimilar)

‘Cosentyx’, the original of ‘GLR-1023’, is an antibody drug that suppresses interleukin-17A (IL-17A), a cytokine that is a signaling substance that regulates immunity in the body. It selectively acts on IL-17A to suppress excessive immune responses and treat autoimmune diseases.

The U.S. Food and Drug Administration (FDA) first approved Cosentyx as a treatment for plaque psoriasis in January 2015, and the Korean Ministry of Food and Drug Safety also approved the drug for the same indication in September of the same year. Cosentyx has since expanded its indications to include psoriatic arthritis, axial spondyloarthritis, hidradenitis suppurativa, juvenile plaque psoriasis, juvenile idiopathic arthritis, and active ankylosing spondylitis.

Prior to Cosentyx, treatment for plaque psoriasis and active ankylosing spondylitis mainly used antibody drugs that block the tumor necrosis factor (TNF) cytokine. However, up to 40% of patients did not respond well to TNF antibody drugs, necessitating new treatment options.

After its launch, ‘Cosentyx’ met this unmet medical need and quickly became a blockbuster drug. Last year, ‘Cosentyx’ sales reached 4.9 billion dollars, or about 6.5 trillion won in our currency. It ranked first in sales of Novartis products in 2023 and accounted for about 10% of total sales (50.5 billion dollars).

Pharmaceutical and bio companies around the world are accelerating the development of similar drugs to share the Cosentyx market. When similar drugs are released, the related market is bound to grow even larger as competing drugs emerge.

However, Novartis is not going to give up its core product market to biosimilars so easily. Novartis has already set up a strong patent barrier. The substance patent that guarantees exclusive sales rights for Cosentyx in the US is scheduled to expire in 2026, but some of the usage patents are scheduled to expire in 2032.

Novartis could use these remaining patents as a weapon in a legal battle that could delay the launch of its biosimilar in the US for a significant period of time. There may be other split patents that other companies are unaware of, so it is still too early to predict when a Cosentyx biosimilar could be launched in the US.

As a result, the industry generally estimates that the Cosentyx biosimilar could be launched in the United States in 2028-2030. This is taking into account legal disputes over patent rights and agreements with original manufacturers.

An industry insider said in a phone call with Health Korea News on the 22nd, “Even if ‘Cosentyx’ biosimilars receive FDA approval, a legal battle over patent rights will be inevitable,” adding, “In most of these cases, the dispute will be resolved through agreement between the parties, so the launch of similar products will not be delayed indefinitely.”

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