On 24 July 2026, Celltrion announced that it has submitted an application for marketing approval to the European Medicines Agency (EMA) for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), seeking all approved reference indications.

The announcement follows Celltrion’s applications for CT-P55 in Canada in May 2026 and Korea in June 2026.  Celltrion is also planning a regulatory filing for CT-P55 in the US.

Celltrion presented results from its Phase 1 trial for CT-P55 in September 2025.  In February 2026, Celltrion received approval from the EMA to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55.  Celltrion expects this will shorten the overall clinical timeline and reduce development expenses for CT-P55.

Secukinumab biosimilars are under development by at least Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis).  In June 2026, CSPC Pharmaceutical announced that China’s National Medical Products Administration (NMPA) had accepted a marketing authorisation application for its Secukinumab Injection.

On 14 July 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety (MFDS) is implementing a revised notice on the Regulation on Approval and Review of Biological Products.  The revisions permit Phase 3 clinical trial data to be waived for biosimilar approval applications if equivalence with the reference drug is sufficiently demonstrated through quality, non-clinical, and pharmacokinetic studies.

The change is aimed at accelerating biosimilar development and aligning Korean regulations with global standards.  The European, US and Canadian regulatory agencies have adopted similarly reduced requirements for Phase 3 clinical trial data, as follows:

• At its meeting from 23-26 March 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a reflection paper which considers that, in certain circumstances, analytical comparability and pharmacokinetic data may be sufficient for approval of biosimilars, with Phase 3 trial data no longer required;
• On 9 March 2026, the FDA issued a new draft guidance on biosimilar development and the BPCIA aimed at reducing upfront research and development timelines and costs for biosimilar developers and lowering the cost of medicines for consumers.  In the new draft guidance, FDA “recommended streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified” stating that “this change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs.”
• On 19 May 2026, Health Canada published its revised Guidance on Information and Submission Requirements for Biosimilar Biologic Drugs, providing that comparative clinical efficacy studies are not typically required for a biosimilar to a Canadian reference biologic drug when the biosimilar has been compared and extensively characterised by analytical and clinical pharmacology studies.

Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Celltrion streamlining its US Phase 3 trial for biosimilar pembrolizumab and EU Phase 3 biosimilar secukinumab trial, Sandoz streamlining its nivolumab and ocrelizumab biosimilar trials and minimising its Phase 3 biosimilar pembrolizumab trial, and Formycon voluntarily terminating its Phase 3 clinical trial for biosimilar pembrolizumab.

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application (MAA) for Secukinumab Injection, biosimilar to Novartis’ Cosentyx®.

Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.  According to the announcement, In phase 1 and 3 studies, CSPC’s biosimilar demonstrated high similarity to Cosentyx® in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

This news follows Celltrion’s announcement earlier in June 2026 that it has filed an application for its secukinumab biosimilar (CT-P55) in Canada, seeking all approved reference indications.  Celltrion is planning additional regulatory filings for CT-P55 in the US, Europe and Korea.

Other secukinumab biosimilars are under development, including Bio-Thera’s BAT2306 (phase 1 trial completed in 2023, phase 3 clinical trial in plaque psoriasis completed in 2024, commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (phase 1 trial completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (phase 3 clinical trial in plaque psoriasis commenced).

On 1 June 2026, Celltrion announced that it has filed an application with Health Canada for marketing authorisation of CT-P55 (secukinumab), biosimilar to Novartis’ Cosentyx®, seeking all approved reference indications.  Celltrion is also planning regulatory filings for CT-P55 in the US, Europe and Korea.

According to Celltrion, its first biosimilar secukinumab application was filed in Canada on the basis that it is a “pro-biosimilar nation” and pursues “policies to promote the introduction of biosimilars and [improve] its regulatory environment”.

The Canadian application is based on Celltrion’s Phase 1 trials, results of which were presented in September 2025.  In February 2026, Celltrion received approval from the European Medicines Agency to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55.

Secukinumab biosimilars are under development by at least Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

On 13 March 2026, Novartis received FDA approval for Cosentyx® (secukinumab) for the treatment of moderate to severe Hidradenitis Suppurativa (HS) in paediatric patients aged 12 years and older.  According to Novartis, Cosentyx® is the only IL-17A inhibitor approved for this age group.

This approval enables earlier intervention for adolescents with HS, who currently have fewer treatment options compared to adults.  HS often emerges during adolescence and can cause irreversible damage if left untreated, so this expanded indication is expected to improve patient access and outcomes.

In October 2023, the FDA approved Cosentyx® to treat moderate to severe HS in adults.  In the same month, the National Institute for Health and Care Excellence (NICE) in England and Wales recommended Cosentyx® for moderate to severe HS.

There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 1 trial completed in 2023 and phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).

On 26 February 2026, Celltrion reported that it plans to expand its biosimilar lineup to 18 products by 2030 with seven candidates that have either entered clinical development or for which investigational new drug applications are being prepared.  Celltrion’s disclosed programmes include CT-P53 biosimilar to Ocrevus (ocrelizumab), CT-P55 biosimilar to Cosentyx (secukinumab) and CT-P52 biosimilar to Taltz (ixekizumab) in autoimmune diseases, as well as cancer therapies CT-P51 biosimilar to Keytruda (pembrolizumab) and CT-P44 biosimilar to Darzalex (daratumumab).

This announcement adds further detail to Celltrion’s commercialisation plans reported in January 2026.

On 11 February 2026, Celltrion announced that it received approval from the European Medicines Agency (EMA) to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).  Celltrion expects this approval to shorten the overall clinical timeline and to reduce development expenses for CT-P55.

The Phase 3 trial is designed to evaluate the efficacy, safety and equivalence of CT-P55 in comparison to Consentyx® in patients with plaque psoriasis.  The FDA approved the global Phase 3 trial in August 2024.  Celltrion presented results from its Phase 1 trial for CT-P55 in September 2025.

Other secukinumab biosimilars in development include Bio-Thera’s BAT2306 (Phase 1 trial completed in 2023, Phase 3 clinical trial completed in 2024; commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (Phase 1 completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (Phase 3 clinical trial, status unknown).

On 28 November 2025, Korea Biomedical Review reported that Novartis’ Cosentyx® (secukinumab) will be reimbursed in Korea from 1 December 2025 for adult patients with severe hidradenitis suppurativa who show an inadequate response to standard systemic therapy.

According to Korea Biomedical Review, reimbursement applies to adults who received an initial diagnosis of hidradenitis suppurativa at least one year earlier, have lesions in two or more distinct anatomical areas with a combined total of at least three abscesses or inflammatory nodules, and have undergone antibiotic therapy for three months or longer without meaningful improvement or were forced to discontinue due to adverse events.

In September 2025, Novartis announced plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from November 2025, offering cash-paying patients access to the drug at 55% off the list price.

There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024, and phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis).

On 10 November 2025, Bio-Thera announced that it has entered into an exclusive commercialisation and licence agreement with Dr Reddy’s in relation to BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).  Under the agreement, Bio-Thera will have responsibility for developing, manufacturing and supplying BAT2306, while Dr Reddy’s will be responsible for regulatory approvals and commercialisation in Southeast Asian countries, including Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Thailand and Vietnam.

Bio-Thera completed a phase 3 clinical trial of BAT2306 in plaque psoriasis in 2024, and a phase 1 trial in 2023.  Secukinumab biosimilars are also under development by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis, status unknown).

Bio-Thera & Dr Reddy’s have previously partnered on biosimilars in SE Asia.  In March 2025, Bio-Thera and Dr Reddy’s announced exclusive commercialisation agreements for BAT2206 and BAT2306, biosimilars to J&J/Janssen’s Stelara® (ustekinumab) and Simponi® (golimumab), respectively, in SE Asia.

On 29 September 2025, Novartis announced that it plans to launch a US direct-to-patient (DTP) platform for Cosentyx® (secukinumab) from 1 November 2025, offering cash-paying patients access to the drug at 55% off the list price.

According to Novartis, Cosentyx® is its top selling product in the US, and the DTP platform will offer the biologic to American patients “at a price that reflects the average savings that insurers and pharmacy benefit managers receive”.

There are a number of secukinumab biosimilars currently under development, including by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024, and phase 1 trial completed in 2023), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).