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 currently recruiting).

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).

On 15 September 2025, Bio-Thera and Saudi Arabia-headquartered Jamjoom Pharmaceuticals Factory Company announced they have entered a strategic commercialisation agreement for BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).

Under the agreement, Bio-Thera will be responsible for product development and global manufacturing, while Jamjoom will have the exclusive rights to commercialise BAT2306 across the MENA region.

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 currently recruiting).

On 10 September 2025, Celltrion announced that it will present its global Phase 1 clinical trial results for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab), at the upcoming 2025 European Academy of Dermatology and Venereology Congress (EADV) to be held 17-20 September 2025.

A global phase 3 trial for Celltrion’s CT-P55 in patients with plaque psoriasis was approved by the FDA in August 2024.

Secukinumab biosimilars are also under development by Bio-Thera (phase 3 clinical trial of BAT2306 in plaque psoriasis completed in 2024; 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).

On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales.  Its quarterly sales are the highest it has ever reported, up 31.2% year on year.

Celltrion attributes its sales growth to the expansion of global prescriptions for its subcutaneous infliximab, Remsima SC® (EU, launched in 2020)/Zymfentra™ (US, launched in March 2024), biosimilar adalimumab.  Yuflyma® (80mg dose US launch January 2024, 40mg dose first approved by the FDA in May 2023, launched 2023, paediatric form US launch March 2024), and biosimilar bevacizumab, Vegzelma® (US launch April 2023).  It has also experienced steady growth in its anticancer products, Truxima® (rituximab, US launch May 2020) and  Herzuma® (trastuzumab, US launch March 2020).

During 2024, Zymfentra™ secured all six public and private insurance contracts operated by the three major prescription drug managers (PBMs) in the US.  Celltrion estimates that it has now secured more than 90% coverage in the US insurance market by completing contracts with 30 mid- to large-sized and regional PBMs and insurance companies.

Celltrion also notes the expansion of its biosimilar portfolio during 2024 with the launch of SteQeyma® (ustekinumab) in major European countries on 1 November.  Celltrion is planning for the 2025 launch of Eydenzelt® (CT-P42, aflibercept).

Celltrion has a number of biosimilars under development, including CT-P41 (denosumab, US aBLA filed December 2023),  CT-P47 (tocilizumab), CT-P55 (secukinumab), CT-P53 (ocrelizumab) and CT-P51 (pembrolizumab).

On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22^nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”.

Celltrion has 8 biosimilars approved in various jurisdictions, namely omalizumab, ustekinumab, adalimumab, aflibercept, rituximab, trastuzumab, bevacizumab, and SC infliximab, and has biosimilar pembrolizumab, secukinumab and denosumab in clinical trials.

According to a report by Korea Economic Daily on 12 September 2024, Celltrion also has plans to establish and build a wholly owned contract development and manufacturing organisation (CDMO) plant with a capacity of 180,000 litres and production lines for antibody-drug conjugates, including Zymfentra^™/Remsima SC® (SC infliximab).

On 29 August 2024, Drug Design, Development and Therapy published the results of a Mabpharm-sponsored phase 1 study regarding CMAB015, biosimilar to Novartis’ Cosentyx® (secukinumab).  The study demonstrated that Mabpharm’s CMAB015 showed equivalent pharmacokinetics and comparable safety and immunogenicity to Cosentyx®.

This news follows FDA approval of Celltrion’s global phase 3 trial of its secukinumab biosimilar, CT-P55, in August 2024.  Bio-Thera is also developing a biosimilar to Cosentyx®, BAT2306, and commenced a phase 3 clinical trial in November 2022, which is estimated to be completed in the second half of 2024.

On 16 August 2024, Bio-Thera announced that it has entered into a licensing and supply agreement with Pharmapark for BAT2306, biosimilar to Cosentyx® (secukinumab).  Under the agreement, Pharmapark will have exclusive rights to distribute and market BAT2306 in Russia and other CIS countries.  This expands upon existing agreements between the two companies in relation to biosimilar golimumab, BAT2506, and BAT2206, an ustekinumab biosimilar.

Bio-Thera commenced a phase 3 clinical trial of BAT2306 in November 2022, which is estimated to be completed in the second half of 2024.

Earlier this week Celltrion announced that it had received FDA approval for its global phase 3 clinical trial of its own Cosentyx® biosimilar, CT-P55. The FDA approved Novartis’ Cosentyx® in October 2023 for moderate to severe hidradenitis suppurativa.  Cosentyx® was also approved in June 2023 by EMA for the same indication.

On 14 August 2024, Celltrion received FDA approval for its global phase 3 clinical trial of CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).

Celltrion reports that global market sales for Cosentyx® reached US $4.98 billion in 2023, and that Novartis’ “material patent” to secukinumab will expire in January 2029 in the US and July 2030 in Europe.

The FDA approved Novartis’ Cosentyx® in October 2023 for moderate to severe hidradenitis suppurativa.  Cosentyx® was also approved in June 2023 by EMA for the same indication.

Bio-Thera is also developing a biosimilar to Cosentyx®, BAT2306, and commenced a phase 3 clinical trial in November 2022, which is estimated to be completed in the second half of 2024.