Health · Pharma & Biotech · 19 mins ago
Celltrion seeks Australian approval for autoimmune biosimilar
Celltrion has applied for Australian approval of Bisequma, a medicine it is developing for autoimmune diseases.
Bisequma is a biosimilar of Novartis’s Cosentyx, which contains the active ingredient secukinumab and blocks a protein involved in inflammation.
The application covers plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis, the same conditions for which the original medicine is approved in Australia.
In a trial involving 172 healthy adults, Celltrion said Bisequma showed similar drug behavior, safety and immune response to Cosentyx.
The company has also applied for approval in Canada, South Korea, the United States and Europe, expanding its applications across several regions.
If approved, Bisequma would add an IL-17A-blocking medicine to Celltrion’s autoimmune treatment range; Australia’s regulator has not yet made a decision.
Celltrion has applied to Australia’s Therapeutic Goods Administration for approval of its autoimmune disease biosimilar, Bysqema.
Bysqema is a biosimilar of Novartis’s Cosentyx and contains secukinumab.
The application covers the same indications approved for Cosentyx in Australia, including plaque psoriasis and psoriatic arthritis.
Celltrion said a clinical study in 172 people found pharmacokinetic equivalence and similar safety and immunogenicity.
Celltrion has also filed for Bysqema approval in Canada, South Korea, the United States and Europe.
- Who
- Celltrion, a South Korean pharmaceutical company.
- What
- It applied to Australia’s Therapeutic Goods Administration for approval of Bysqema, a Cosentyx biosimilar.
- When
- Celltrion announced the application on November 12, 2026.
- Where
- Australia.
- Why
- The application seeks approval to market Bysqema for autoimmune disease indications; Celltrion said it aims to expand its biosimilar business and supply medicines to patients.
This story does not have two clearly opposing sides.
Celltrion filed for Bysqema approval in Canada.
Celltrion filed for Bysqema approval in South Korea.
Celltrion filed for Bysqema approval in the United States and Europe.
Celltrion announced that it had applied to Australia’s TGA for approval.
- Product
- Bysqema (secukinumab)
- Reference medicine
- Cosentyx, a biosimilar of Novartis’s medicine
- Trial
- 172 people; pharmacokinetic equivalence and similar safety and immunogenicity reported
- Australian indications
- Plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and juvenile idiopathic arthritis
- Application date
- November 12, 2026
- Cosentyx sales
- Articles report differing figures for last year: about US$6.668 billion; the reported won equivalent differs.
What people are saying
Australia has policies and a prescribing environment favorable to biosimilars, and our existing products are performing well in the country.
Bysqema is moving ahead with its global market entry by filing for approval in Australia, following the United States, Europe and South Korea.