The blockbuster drug Stelara, which generated over 15 trillion won in sales last year, has officially opened the market for its biosimilars. Seven types of biosimilars, including products from domestic corporations such as Samsung Bioepis, Celltrion, and Dong-A ST, are expected to engage in fierce competition in the U.S., the world's largest market, starting this year.
Stelara is an anti-inflammatory autoimmune disease treatment developed by Johnson & Johnson's subsidiary Janssen. It is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. The annual global sales scale reaches $10.361 billion (15 trillion won). U.S. sales amount to $6.72 billion (10 trillion won), accounting for about 70% of the global market.
So far, a total of seven products have received sales approval as Stelara biosimilars in the U.S. Amgen from the U.S., Alvotech from Iceland, and Samsung Bioepis from Korea have launched products, with an additional four expected to hit the market within the first half of the year.
The first company to enter the market is Amgen from the U.S. In November 2023, it was the first to receive approval from the U.S. Food and Drug Administration (FDA) for the Stelara biosimilar "Wezlana" and began sales in the U.S. on January 1. On the 21st, Alvotech launched its second Stelara biosimilar, "Selarsdi."
Samsung Bioepis announced on the 24th (local time) that it launched the Stelara biosimilar "PYZCHIVA" in the U.S. through its local partner Sandoz. Samsung Bioepis received FDA approval for PYZCHIVA in June last year and was authorized to launch it in Europe in April, with a launch in July.
Celltrion and Dong-A ST also plan to launch Stelara biosimilars in the U.S. this year. Celltrion received FDA approval for "Steqeyma" in December last year and is preparing for a launch this month. In Europe, it received approval in August last year and launched in November.
Dong-A ST is expected to launch "IMULDOSA" in the U.S. in May. Earlier, it received approval from the U.S. FDA in October last year and a recommendation for product approval from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
As multiple products are released around the same time, the earlier a product is launched, the better the opportunity to secure market share. However, in the U.S. market, which is influenced by private insurers, even latecomers can secure market share by aggressive marketing to get their products listed on insurer prescription lists and through low-price strategies.
Samsung Bioepis and Dong-A ST have entrusted sales and marketing to local partners familiar with the market conditions. Samsung Bioepis signed a North America and Europe sales contract for PYZCHIVA last year with the Swiss pharmaceutical company Sandoz. Sandoz has contracted with major pharmacy benefit managers (PBMs) in the U.S. to sell PYZCHIVA. PBMs play a key role in the distribution of prescription drugs in the U.S. healthcare system.
Dong-A ST transferred the global rights for IMULDOSA to Indian pharmaceutical company Intas in 2021. Intas has entrusted the U.S. sales of IMULDOSA to its subsidiary Accord Healthcare. In contrast, Celltrion has built its own sales network without local partners. This direct sales system has the advantage of reducing the expenses associated with consignment sales, thereby lowering wholesale prices.
A representative from the domestic pharmaceutical industry noted, "In the U.S. market, having a local partner with extensive experience in dealing with private health insurers is advantageous," but added, "Even a domestic company can establish price competitiveness by building its own direct sales network, so quick responses are needed according to each company's circumstances."