At the J.P. Morgan Healthcare Conference on 14 January 2026, Samsung Epis Holdings announced the addition of six biosimilar candidates to Samsung Bioepis’ pipeline: dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.

The announcement confirms the November 2025 report that Samsung Bioepis had commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), with the biosimilar in the early development stage in preparation for preclinical trials.  The same report had also indicated that Samsung Bioepis is developing biosimilars to Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).

Samsung Bioepis has launched 11 biosimilars to 10 INNs on market around the world and has a biosimilar to MSD’s Keytruda® (pembrolizumab), (SB27) in phase 1 and 3 clinical trials (commenced April 2024).  The company is aiming to have 20 biosimilars in its portfolio by 2030.

At the J.P. Morgan Conference, Samsung Epis also announced that the FDA has approved Samsung Bioepis’ investigational new drug application (IND) for SBE303, an antibody-drug conjugate, which is expected to enter a Phase 1 first-in-human clinical trial in patients with advanced refractory solid tumours this year.

There are a number of companies with dupilumab biosimilars under development.  In August 2025, CSPC Pharmaceutical announced that it received approval from China’s National Medical Products Administration (NMPA) to conduct clinical trials of its dupilumab injection.  In June 2025, Bio-Thera Solutions and Costa Rican-based SteinCares announced an agreement to commercialise biosimilar dupilumab across Latin America, with Bio-Thera responsible for product development and supply, and SteinCares responsible for commercialisation.  Alvotech and Advanz entered into partnership agreements in February 2023, May 2023 and June 2024 for the commercialisation of various biosimilars, including dupilumab, in Europe and certain other countries.

Biosimilar development of guselkumab is also underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

Biosimilars to Takeda’s Entyvio® (vedolizumab) are in development by at least Alvotech (Phase 3 clinical trial for AVT16 commenced September 2024), Intas Pharmaceuticals (approval from India’s CDSCO for a Phase 1 bioequivalence study of INTP53 obtained in February 2025) and Polpharma Biologics (which entered into licensing agreements with Fresenius Kabi and MS Pharma for commercialisation of PB016 in August and September 2025).

Ocrelizumab biosimilars (referencing Roche’s Ocrevus®) are in clinical trials sponsored by Biocad (Phase III, enrolment commenced November 2025), Sandoz (comparative pharmacokinetic trial underway), Amgen (Phase III trial reported in January 2025) and Celltrion (Phase III IND for CT-P53 partially approved by the EMA in August 2023).

On 19 December 2025, Johnson & Johnson announced that the European Commission has approved an indication extension for Tremfya® (guselkumab) as a subcutaneous treatment for moderate to severe plaque psoriasis (Pso) in children and adolescents aged six and older who are candidates for systemic therapy.

Tremfya® is already approved in Europe for a number of indications, including moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients, adults with moderately to severely active ulcerative colitis (April 2025) and adults with moderately to severely active Crohn’s disease (May 2025).

The indication extension in Europe follows the FDA’s September 2025 approval of a Tremfya® paediatric indication extension for the treatment of severe plaque psoriasis and active psoriatic arthritis in children aged six years and older weighing at least 40 kg.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 21 November 2025, Korean news outlet, The Asia News Daily, reported that Samsung Bioepis has commenced development of a biosimilar to AstraZeneca/Daiichi Sankyo’s antibody-drug conjugate Enhertu® (trastuzumab deruxtecan).  According to the report, the biosimilar is still in the early development stage, in preparation for preclinical trials.

The report also suggests that Samsung Bioepis is developing biosimilars to MSD’s Keytruda® (pembrolizumab), Regeneron/Sanofi’s Dupixent® (dupilumab), Janssen’s Tremfya® (guselkumab) and Eli Lilly’s Talz® (ixekizumab).  Samsung Bioepis announced the commencement of Phase 3 clinical trials for SB27, biosimilar to MSD’s Keytruda® (pembrolizumab) on 5 April 2024.  Samsung Bioepis has not issued press releases to date in relation to the development of any of the other biosimilars referred to in The Asia News Daily report.

Enhertu® is the subject of a collaboration between AstraZeneca and Daiichi Sankyo entered in March 2019, under which the companies jointly develop and commercialise trastuzumab deruxtecan globally, except in Japan where Daiichi Sankyo maintains exclusive rights.  Daiichi Sankyo is solely responsible for manufacturing and supply.

On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease and ulcerative colitis (UC), who have had an inadequate response, lost response, or were intolerant to either conventional therapy, a biologic treatment, or a Janus kinase (JAK) inhibitor.

This follows the recommendation of the National Institute for Health and Care Excellence (NICE) in August 2025 for use within the UK’s NHS.

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease (IV and SC) and UC (IV) in May 2025, and has been approved for the same indications in the EU (Crohn’s (IV and SC), May 2025; UC (IV), April 2025).  In October 2025, the European Commission approved a SC dosage regimen for UC.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 24 October 2025, Johnson & Johnson announced that the European Commission has approved a subcutaneous (SC) induction dose regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic treatment.

This follows approval of the same induction regimen in the US one month earlier.  Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease (IV and SC) and UC (IV) in May 2025, and has been approved for the same indications in the EU (Crohn’s (IV and SC), May 2025; UC (IV), April 2025).

On 16 October 2025, the CHMP announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to Tremfya® for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.  Tremfya® is already approved in Europe for moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 16 October 2025, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the highlights of its October 2025 meeting, including a positive opinion for an indication extension to J&J/Janssen’s Tremfya® (guselkumab).  The recommended extension is the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.

Tremfya® is already approved in Europe for moderate to severe plaque psoriasis and active psoriatic arthritis in adult patients.  It has since received European approval for adults with moderately to severely active ulcerative colitis (April 2025) and for adults with moderately to severely active Crohn’s disease (May 2025).

The CHMP’s positive opinion follows the FDA’s September 2025 approval of a Tremfya® paediatric indication extension for the treatment of severe plaque psoriasis and active psoriatic arthritis in children aged six years and older weighing at least 40 kg.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 29 September 2025, Johnson & Johnson announced that the US FDA has approved an indication extension for Tremfya® (guselkumab) for the treatment of severe plaque psoriasis (PsO) and active psoriatic arthritis (PsA) in children aged six and older, weighing at least 40 kg.  J&J submitted the two supplemental Biologics Licence Applications (sBLAs) for these indications in December 2024.

Tremfya® was first approved in the US for PsO (in adults) in July 2017.  Earlier in September 2025, the FDA approved a subcutaneous induction regimen of Tremfya® for the treatment of adults with moderately to severely active ulcerative colitis (UC).  This followed the approval of an intravenous (IV) induction regimen for UC in September 2024.

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the MENA region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 19 September 2025, Johnson & Johnson announced that the FDA has approved a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC).  The BLA for the SC regimen was accepted in November 2024 and followed the approval of Tremfya® with intravenous (IV) induction for UC in September 2024.

In March 2025, the FDA approved Tremfya® for the treatment of moderately to severely active Crohn’s disease in adults.  With the latest approval, Tremfya® is the first and only IL-23 inhibitor to offer both SC and IV induction options for the treatment of UC and Crohn’s disease in the US.

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease and UC in May 2025 and has been approved for the same indications in the EU (Crohn’s, May 2025; UC, April 2025).

Biosimilar development of guselkumab is underway.  In September 2025, Polpharma and MS Pharma announced that they entered into a licensing agreement for the commercialisation of PB019, biosimilar guselkumab, in the Middle East and North Africa (MENA) region.  In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.

On 2 September 2025, Polpharma Biologics S.A. and MS Pharma announced that they have entered into licensing agreements for the commercialisation of proposed biosimilar candidates to guselkumab (PB019, referencing Janssen’s Tremfya®), ocrelizumab (PB018, referencing Roche’s Ocrevus®) and vedolizumab (PB016, referencing Takeda’s Entyvio®), in MENA (Middle East and North Africa).

Under the agreements, MS Pharma will be responsible for registration, marketing, and distribution across MENA, while Polpharma will maintain responsibility for development, manufacture and supply.  Both parties have agreed to transfer fill and finish activities to MS Pharma’s biologics manufacturing facility in Saudi Arabia.

In August 2025, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab).

There are a number of other vedolizumab biosimilars in development, including by Intas (INTP53) and Alvotech (AVT16).

At least Sandoz (CYB704), Amgen (ABP 692) and Celltrion (CT-P53) have ocrelizumab biosimilars in development, while Alvotech is developing a guselkumab biosimilar which is to be commercialised in the EU, UK and Switzerland by Advanz Pharma.

On 28 August 2025, the UK’s NICE published guidance recommending J&J/Janssen’s Tremfya® (guselkumab) for use within England’s NHS for previously treated moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (UC).

Tremfya® was approved by the UK’s MHRA for treatment of Crohn’s disease and UC in May 2025 and has been approved for the same indications in the EU (Crohn’s, May 2025; UC, April 2025) and the US (Crohn’s, March 2025; UC, September 2024).

In 2023, Alvotech and Advanz Pharma entered into a partnership agreement to commercialise a proposed guselkumab biosimilar in the EU, UK and Switzerland.