Celltrion Applies for Australian Approval of "Bisequma," Accelerating Commercialization
Covers all approved indications for Cosentyx in Australia
Celltrion has applied to Australia's Therapeutic Goods Administration (TGA) for marketing authorization of Bisequma (active ingredient: secukinumab), a treatment for autoimmune diseases. After applying for approval in Canada, South Korea, the United States and Europe, the company is expanding its applications to Oceania as it prepares for commercialization.
According to Celltrion on November 12, the application covers plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis, which are all indications for which the original drug is approved in Australia. In a clinical trial involving 172 healthy adults, Celltrion confirmed that Bisequma was pharmacokinetically equivalent to the original drug, with similar safety and immunogenicity.
Bisequma is a biosimilar of Cosentyx, an interleukin (IL)-17A inhibitor. Cosentyx generated global sales of approximately $6.668 billion last year, equivalent to about KRW 9.3 trillion. Celltrion has successively applied for approval in Canada in May, South Korea in June, and the United States and Europe in July.
Celltrion expects Bisequma to have favorable prospects for entering the Australian market, given the country's policies and prescribing environment that are supportive of biosimilars, as well as the strong performance of the company's existing autoimmune disease products there. With the addition of Bisequma, Celltrion's autoimmune disease portfolio will expand further, spanning tumor necrosis factor (TNF-alpha) inhibitors such as Remsima and Yuflyma, and interleukin inhibitors such as Steqeyma and Aptozma. Celltrion aims to increase its biosimilar lineup from 11 products currently to 18 by 2030.
Hot Picks Today
"Two Spend 500,000 Won in a Flash, Yet Wait Two Hours?" ... 'Dreamland' Shunned by Kids and Foreign Tourists
- The Era of Getting 200 Million Won After 30 Years Is Over... A Japanese Bank's "Perpetual Department Head" Who Just Clocked In Cries Out
- Spain Hit by Its Worst Tragedy... Lee Kangin, Moreno and Real Madrid Join Soccer World in Mourning
- They Said, “Make It Your Home for Life” - Then Suddenly Kicked 200 Passengers Off... What Happened to the Around-the-World Cruise?
- "130 Rice Bowls Sold Out in a Day"... 'Unfiltered Face' Adds 8 Million Won to Night Market Sales: China's Bungeunwoo
A Celltrion representative said, "Bisequma is gaining momentum in expanding its global reach, with marketing authorization applications filed in Australia following the United States, Europe and South Korea. We will continue to expand the regions where we seek approval, strengthen the growth drivers of our biosimilar business, and rapidly supply high-quality medicines to patients around the world."
© The Asia Business Daily. All rights reserved. Unauthorized AI training and use prohibited.
