Samsung’s biotech duo on a roll with $1.1 bn CMO order

Samsung Group is on track to rise to the top of biosimilar companies in the world and become South Korea’s largest drug maker for contract manufacturing since its foray into the biotechnology market in 2011.

Samsung Biologics Co., a contract manufacturing organization (CMO), said on Tuesday it has bagged its largest-ever order worth $1.06 billion, under which it will deliver a drug product to a US pharmaceutical company by the end of 2030.

The deal represents 42% of the orders it received in the entire year of 2023. It did not disclose the name of the product or the US company, citing their confidentiality agreement.

Samsung Securities senior analyst Seo Keunhee assumes the product for the CMO order would be a blockbuster drug, given the size of the deal. She said the drug could be an Alzheimer’s treatment, a cancer immunotherapy drug, or an antibody-drug-conjugate.

The same day, Samsung Bioepis Co. said that Pyzchiva, its biosimilar to Johnson & Johnson’s autoimmune disease treatment Stelara, has won US Food and Drug Administration (FDA) approval, becoming its seventh biosimilar to get the nod from the FDA.

Pyzchiva will be commercialized by Sandoz, a Switzerland-based biosimilar manufacturing arm of Novartis AG, in the US.

SAMSUNG BIOLOGICS

With the latest CMO deal, Samsung Biologics has secured a total of 2.5 trillion won ($1.8 billion) worth of orders so far this year, bringing its cumulative orders received to $12.5 billion since its inception in 2011.

This year, its revenue is projected to surpass the 4-trillion-won ($2.9 billion) mark for the first time as a South Korean biosimilar maker.

Its sales growth is credited to its overwhelming production capacity, alongside manufacturing speed and quality. When its fifth plant is fully operational next year, its capacity will reach 784,000 liters a year.

Of the seven orders received this year, six were follow-up orders to increase the production volume of existing contracts.

Samsung counts 16 of the top 20 global pharmaceutical companies in terms of market capitalization as its customers.

SAMSUNG BIOEPIS

Pyzchiva has been approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. Sales of its original drug Stelara have reached around 14 trillion won annually.

As of June 2024, Samsung Bioepis has seven biosimilars approved in the US, the largest number of FDA-approved biosimilars for a company in the world. It has now matched that of Amgen Inc., a US biopharmaceutical company.

Pfizer Inc. and Sandoz have five and four biosimilars approved by the FDA, respectively.

Samsung also has four generic drugs commercially available. Additionally, it is expected to win FDA approval for its first hematology biosimilar to Soliris, Alexion Pharmaceuticals’s blockbuster disease, this month.

If the biosimilar, dubbed Epysqli, gets the greenlight from the US drug authorities as a rare blood disorder treatment, Samsung will leap to the top of biosimilar makers in the world with the largest number of FDA approvals.

Alexion Pharmaceuticals is a unit of the US-based AstraZeneca.

Write to Dae-Kyu Ahn at powerzanic@hankyung.com
Yeonhee Kim edited this article