On 8 June 2026, Alvotech announced that its Biologics License Application (BLA) for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), has been accepted for review by the FDA.  AVT16 is presented in a lyophilised vial for intravenous administration.  This is the first reported FDA application for a vedolizumab biosimilar.

According to Alvotech’s announcement, under a partnership with Teva, Alvotech is responsible for the development and manufacturing of AVT16, while Teva is responsible for its commercialisation.  Alvotech and Teva first entered into a strategic partnership in relation to biosimilar candidates in August 2020, which was expanded in 2023.

Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), having announced positive results from a PK study for the product in February 2026.

Other vedolizumab biosimilars are in development, including Intas’ INTP53 (approval to conduct Phase I bioequivalence study received in February 2025) and Polpharma Biologics’ PB016 (global licensing agreement with Fresenius Kabi (excluding MENA region) entered in August 2025, licensing agreement with MS Pharma for MENA region signed in September 2025).  In January 2026, Samsung Bioepis announced that it had a vedolizumab biosimilar under early-stage development and, in March 2026, Sandoz announced it entered into a global licence, development and commercialisation agreement (excluding certain Asian countries) with Samsung Bioepis for up to five biosimilars, including vedolizumab.

During its Q4/2025 Earnings Call on 19 March 2026, Alvotech provided updates on its launch plans and regulatory applications for various biosimilars, including golimumab, aflibercept, vedolizumab and pembrolizumab.

Alvotech confirmed that Gobivaz® (AVT05) was launched in the EU in December 2025 as the first available biosimilar to J&J’s Simponi® (golimumab), following its November 2025 EU marketing authorisation.  Gobivaz® is being commercialised by Advanz Pharma in the UK and Europe under a May 2023 licence and supply agreement with Alvotech.  In Japan, Alvotech’s commercialisation partner, Fuji Pharma, is planning to launch Gobivaz® (approved in September 2025) in May 2026.  An application for approval of AVT05 has also been filed in Canada, with a decision expected in H1 2026.  To date, the application for AVT05 is the only known golimumab biosimilar application filed in Canada.

Alvotech indicated that it is aiming to file the first regulatory submission for its high dose aflibercept biosimilar, AVT29, sometime in 2026.  AVT29, biosimilar to Regeneron/Bayer’s Eylea™ 8mg/Eylea HD®, will be commercialised by Advanz Pharma in the EU and by Teva in the US.  Under settlement agreements with Regeneron/Bayer, Alvotech has a Q4/2026 US launch date for AVT06 (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), 2mg), subject to FDA approval, and various 2026 launch dates, with its partners STADA and Advanz Pharma having already launched AVT06 in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®), respectively.

Following the recent announcement of positive results from its PK study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab), Alvotech said that it is planning to file regulatory submissions for a vedolizumab biosimilar later in 2026.  Alvotech expects to be among the first to launch an Entyvio® biosimilar and has both IV (AVT16) and SC (AVT80) formulations in development.

As previously reported, Alvotech has a biosimilar to MSD’s Keytruda® (pembrolizumab) in its pipeline, on which it is partnering with Dr Reddy’s.  During the Q4 2025 Earnings Call, Alvotech said that it is expecting it will be in a position to file a marketing authorisation application for the pembrolizumab biosimilar in 2028.

Alvotech also provided an update on the Complete Response Letters it received from the FDA in relation to its denosumab, golimumab and aflibercept biosimilars, announcing that it has undertaken a remediation project and is on track to resubmit its applications to the FDA in the first half of 2026.

On 18 March 2026, Sandoz announced it has entered into a licence, development and commercialisation agreement with Samsung Bioepis for up to five biosimilars, including vedolizumab.

Under the agreement, Sandoz will have exclusive rights to commercialise the biosimilars globally (excluding China, Hong Kong, Taiwan, Macau and the Republic of Korea), while Samsung Bioepis will be responsible for development, manufacturing and regulatory submissions in key markets.

The first biosimilar to be licensed under the agreement will be a biosimilar to Takeda’s Entyvio® (vedolizumab).  In January 2026, Samsung Bioepis announced that it had a vedolizumab biosimilar under early-stage development.

Sandoz and Samsung Bioepis previously entered into a development and commercialisation agreement in September 2023 for Pyzchiva®/SB17, biosimilar to J&J’s Stelara® (ustekinumab).  Under that agreement, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

In December 2025, the companies signed a commercialisation agreement for Epysqli™, biosimilar to Alexion’s Soliris® (eculizumab), for the Middle East and Africa region.

On 5 February 2026, Alvotech announced positive results from a pharmacokinetic study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab).

The Phase 1 study evaluated the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio® in 385 healthy adults.  The trial met all the primary endpoints and demonstrated the pharmacokinetic similarity for both the subcutaneous and intravenous routes of administration of the vedolizumab biosimilar when compared with Entyvio®.  Alvotech is planning  regulatory submissions based on the results of the study.

Alvotech is currently developing two biosimilars to Entyvio®, AVT16 for intravenous administration, and AVT80 for subcutaneous administration.  Alvotech commenced a Phase 3 clinical trial for AVT16 in September 2024 in moderate to severe ulcerative colitis.

Other vedolizumab biosimilars in development include Intas’ INTP53 (approval to conduct Phase I bioequivalence study received in February 2025) and Polpharma Biologics’ PB016 (licensing agreement with MS Pharma signed in September 2025 for MENA region).  In January 2026, Samsung Bioepis announced that it has added a vedolizumab biosimilar to its pipeline.

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 8 January 2026, Takeda announced that it has entered a global collaboration and licence agreement with Halozyme Therapeutics, Inc, which grants Takeda exclusive rights to Halozyme’s Enhanze® drug delivery technology for use with Takeda’s Entyvio® (vedolizumab).

Under the agreement, Takeda will make an upfront payment and potential future development and commercial milestone payments to Halozyme.  Halozyme will also receive royalties on sales of products containing vedolizumab in combination with Enhanze®.

Entyvio® is approved including in the US and EU for adults with ulcerative colitis and moderately to severely active Crohn’s disease in both IV and subcutaneous formulations.

There are a number of vedolizumab biosimilars in development.  In September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  Alvotech’s AVT16 is subject to a 2023 licence agreement with Advanz, under which Advanz will commercialise the biosimilar in Europe, the UK and Switzerland.

In February 2025, Intas Pharmaceuticals received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)).  In August 2025 and September 2025 respectively, Polpharma Biologics entered into a global licensing agreement (excluding the MENA region) with Fresenius Kabi for the commercialisation of PB016 (vedolizumab) and a licence agreement with MS Pharma for commercialisation in the MENA region of a number of biosimilars, including PB016.

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 5 August 2025, Polpharma Biologics and Fresenius Kabi announced that they have entered into a global licensing agreement (excluding Middle East & North Africa) for the commercialisation of PB016, biosimilar to Takeda’s Entyvio® (vedolizumab).  PB016 was developed by Polpharma, which will remain responsible for manufacture.  Fresenius Kabi will be responsible for commercialisation.

In February 2024, Polpharma Biologics announced that PB016 demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.  Phase 3 trials comparing PB016 to Entyvio® are underway, with estimated completion in September 2025.

There are a number of other vedolizumab biosimilars in development.  In February 2025, Intas Pharmaceuticals received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)).  In September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  Alvotech’s AVT16 is subject to a 2023 licence agreement with Advanz, under which Advanz will commercialise the biosimilar in Europe, the UK and Switzerland.

Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)), with Takeda’s Entyvio® (vedolizumab).

This follows Intas’ August 2024 CDSCO approval to conduct a Phase 3 clinical study of INTP53 in patients with moderate to severely active ulcerative colitis.

Intas is not the only company to have a vedolizumab biosimilar in development.  For example, in September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis.  In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.

On 13 November 2024, Alvotech announced its financial results for the first 9 months of 2024, reporting an increase in total revenues of US $300 million and an over four-fold increase in product revenue, year on year.

Product development highlights for the year to date include the EMA acceptance of marketing authorisation applications for AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in October 2024, and AVT05 (golimumab), biosimilar to Janssen’s Simponi®, in November 2024.  Alvotech has commercialisation agreements for European markets with STADA and Dr Reddy’s in relation to AVT03 and with Advanz Pharma in relation to AVT05.

In October 2024, the US FDA also approved a new presentation of Alvotech and Teva’s Selarsdi®/AVT04 (ustekinumab-aekn), biosimilar to Janssen’s Stelara®, in a 130 mg/26mL single-dose vial for IV infusion and a label expansion to include treatment for Crohn’s disease and ulcerative colitis.  Alvotech expects a February 2025 US launch for Selarsdi®.

A further highlight is said to be Alvotech’s commencement in September 2024 of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

Alvotech reports licence and other revenue for the first 9 months of 2024 totalling US$210.5 million, primarily attributable to R&D milestones for the approval of AVT04/Uzpruvo® (ustekinumab) in Europe in January 2024, the commencement of the AVT16 (vedolizumab) clinical trials, European MAA submissions for AVT03 (denosumab) and AVT06 (aflibercept), and confirmatory efficacy and safety trials completed for AVT03 (denosumab) and AVT05 (golimumab).  There was also achievement of a performance milestone for the product launch of AVT04 (ustekinumab) in Japan (as Ustekinumab BS (F)) and Europe (as Uzpruvo®), a sales target for AVT02 (adalimumab) in Europe and Canada, and a product launch of AVT02 (as Simlandi®) in the US.