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.

On 5 June 2026, Shanghai Henlius Biotech announced that the first US patient has been dosed in its international Phase 1 clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).  The study had previously completed first patient dosing in China.

The Phase 1 study, initiated in September 2025, is designed to evaluate the pharmacokinetic (PK) profile, efficacy, safety and immunogenicity of HLX17 versus US-sourced Keytruda® in patients with multiple resected solid tumours, including non‑small cell lung cancer, melanoma, or renal cell carcinoma.  Primary completion of the study is expected in April 2027.

A second study (integrated Ph 1/3) was initiated by Henlius in April 2025 to evaluate the efficacy, safety PK profile and immunogenicity of HLX17 versus Keytruda® in the first-line treatment of advanced nsNSCLC.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).

There are multiple pembrolizumab biosimilars in development.  Formycon’s FYB206 appears to be the front runner, having demonstrated pharmacokinetic bioequivalence with Keytruda® in its “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has expressed optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region,  and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Samsung Bioepis, Amgen, mAbxience, Sandoz, Celltrion, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

On 4 June 2026, Kashiv BioSciences announced that Health Canada has accepted for review the market authorisation application (MAA) for ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018 (also referred to as AVT23) in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.

The Canadian filing follows a series of regulatory advances for ADL-018.  Marketing applications for ADL-018 were accepted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) in March 2025 and by the European Medicines Agency (EMA) in October 2025.

Beyond Canada, Kashiv has agreements for the commercialisation of ADL-018 with Brazilian pharmaceutical company, CRISTÁLIA, for the Latin American market (11 August 2025) and MS Pharma for MENA markets (August 2025).

The only omalizumab biosimilar currently approved in Canada, and anywhere else in the world, is Celltrion’s Omlyclo®.  Omlyclo® was approved in Canada in 75mg and 150mg formulations in December 2024 and in 300mg PFS and autoinjector presentations in January 2026.

Omlyclo® has also been approved in: the EU (May 2024 and November 2025 (300mg)); Korea (June 2024 (PFS), December 2025 (autoinjector), 300mg formulation launched 30 March 2026)); Australia (November 2024); the US (March 2025 (75 mg/0.5ml and 150 mg/ml PFS) and December 2025 (300mg)); New Zealand (April 2025); and Japan (March 2026).  Celltrion commenced its European rollout of Omlyclo® in Norway in September 2025, and completed its launch in major European countries including Germany, Spain, the UK and France in November 2025.  In late November 2025, Celltrion announced that it launched Omlyclo® in Brazil.

Omalizumab biosimilars are also in development by at least CuraTeQ (Ph 3 study results announced April 2026) and Teva (acceptance for review of biosimilar omalizumab applications in US and EU announced March 2026).

On 4 June 2026, GxP News reported that Belarusian company, BioImmunity LLC, has obtained registration in Belarus of its biosimilar to Novartis’ Ilaris® (canakinumab) and is seeking approval in Russia.  If registered, this will become the second canakinumab biosimilar approved in Russia after Generium’s Limiris™ (September 2025).

There have not been any reports of canakinumab biosimilars approved elsewhere.  However, in May 2025, Alvotech and Advanz expanded their partnership to include the development and commercialisation of a canakinumab biosimilar (AVT48) in Europe.

On 4 June 2026, Alvotech announced that it has resubmitted to the FDA its Biologics License Applications for AVT05 (golimumab), biosimilar to Janssen’s Simponi® and Simponi Aria®, and AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.  Alvotech expects the FDA to conduct a 6-month review of the resubmitted BLAs, in line with applicable regulatory timelines.  Both AVT05 and AVT06 will be commercialised in the US by Teva.

The BLAs were resubmitted following completion of an FDA “routine cGMP surveillance inspection” of Alvotech’s Reykjavik manufacturing facility and the provision by Alvotech of responses to observations raised as a result of that inspection.  Alvotech received Complete Response Letters from the FDA for its golimumab, aflibercept, and denosumab (AVT03) biosimilar BLAs in November 2025, December 2025 and January 2026, respectively, and subsequently undertook a “remediation project”.

Alvotech’s BLA for AVT05 was first accepted for review by the FDA in January 2025.  In September 2025, AVT05 was the first golimumab biosimilar to be approved worldwide, with its approval in Japan as Gobivaz®.  Gobivaz® received a positive CHMP opinion from the EMA in September 2025, followed by approval in Europe and the UK in November 2025, where it is commercialised by Advanz Pharma.  Accord BioPharma’s Immgolis™ and Immgolis Intri™ were the first golimumab biosimilars approved in the US in May 2026, although their launch date is uncertain given ongoing BPCIA litigation commenced by Janssen against Accord/Bio-Thera in March 2026.

AVT06 (aflibercept, 2mg) has a Q4/2026 US launch date (subject to FDA approval) under a settlement agreement between Alvotech and Regeneron/Bayer.  AVT06 has already been launched in Germany (under the name Afiveg®) and in the UK, Canada and Japan (under the name Mynzepli®).  The only biosimilar aflibercept currently on the market in the US is Amgen’s Pavblu™, which launched in October 2024 after the US Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction in relation to the biosimilar.  There are a number of approved aflibercept biosimilars, some of which have scheduled H2 2026 launch dates as a result of litigation settlements, including Biocon’s Yesafili® (approved May 2024, due to launch H2/2026), Formycon/Klinge’s Ahzantive® (approved June 2024, due to launch Q4/2026), Sandoz’s Enzeevu® (approved August 2024, due to launch Q4/2026), and Celltrion’s Eydenzelt® (approved October 2025, due to launch Q4/2026).

Dr Reddy’s, Alvotech’s partner in the US for AVT03, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab), is responsible for resubmitting the BLA for that biosimilar.  AVT03 is currently the subject of BPCIA litigation commenced by Amgen in November 2025 alleging infringement of 31 US patents.

On 2 June 2026, the FDA approved Lupin’s Ranluspec® (ranibiziumab-hkdz) as an interchangeable biosimilar of Genentech’s Lucentis®.  Ranluspec® is approved in both vial and pre-filled syringe presentations for the treatment of nAMD, macular oedema following retinal vein occlusion, diabetic macular oedema, diabetic retinopathy, and myopic choroidal neovascularization.

The following day, on 3 June 2026, Xbrane announced that the FDA accepted its biosimilar ranibizumab BLA, which has been given a Biosimilar User Fee Act (BsUFA) action date of 29 October 2026.  The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialising the product in the US under the name Lucamzi™.

Xbrane resubmitted its BLA in April 2026 following an FDA Complete Response Letter (CRL) received in October 2025.  This was the second CRL issued in relation to Xbrane’s ranibizumab BLA following a first CRL in April 2024 identifying issues relating to (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.

The first ranibizumab biosimilar approved in the US was Samsung Bioepis’ Byooviz® (September 2021), followed by Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), and Formycon’s Nufymco® (December 2025).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®, and was launched in the EU in April 2023.  Lupin’s Ranluspec® was approved in the EU in February 2026, where it is being commercialised by Sandoz under an August 2025 agreement.

On 2 June 2026, South Korean-headquartered Daewoong Pharmaceutical and Chinese-based global biologics contract development and manufacturing organisation (CDMO), Chime Biologics, announced that they have entered a strategic partnership agreement for the development, manufacture and commercialisation of a biosimilar of Sanofi/Regeneron’s Dupixent® (dupilumab).

Under the agreement, Chime will support the development and manufacture of Daewoong’s dupilumab biosimilar, while both companies will collaborate on commercialisation.

Although Daewoong has previously partnered on biosimilars in the Korean market (for example, promoting and launching Celltrion’s denosumab biosimilars in Korea), the dupilumab agreement with Chime is intended to be the foundation of its biologics expansion strategy, building the Dupixent® biosimilar into a global product.

Biosimilar dupilumab is under development by at least Samsung Bioepis, Bio-Thera Solutions and Costa Rican-based SteinCares, Alvotech and Advanz, Binnopharm and Mabwell and Amneal.  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 January 2026, Chong Kun Dang received approval from the EMA and UK MHRA for its phase 1 clinical trial protocol for CKD-706 (dupilumab).

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 1 June 2026, BMS announced that the European Commission has approved Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for the treatment of adults and adolescents over 12 years of age with previously untreated Stage III or IV classical Hodgkin Lymphoma (cHL).  The Opdivo® plus AVD combination is the first immunotherapy-based regimen available in the EU for newly diagnosed advanced cHL.

This cHL indication was recommended by the CHMP in April 2026 and approved by the FDA in March 2026.  BMS also added another cHL indication to its European registration in March 2026, with approval for nivolumab in combination with brentuximab vedotin for the treatment of relapsed or refractory cHL after one prior line of therapy.

A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Zydus’ ZRCr-4276.

On 31 May 2026, Samsung Bioepis announced that it has launched Opuviz™/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg, in Europe through direct sales.

The launch follows a settlement agreement between Samsung Bioepis and Regeneron/Bayer in relation to the aflibercept biosimilar announced in January 2026.  Under the agreement, Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024).  Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of Opuviz™ in the US from January 2027.

Opuviz™ was the third aflibercept biosimilar to be approved in the EU in November 2024 and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).

The European launch of Opuviz™ comes two weeks after Formycon/Klinge launched their aflibercept biosimilar, FYB203, in key European markets.  Aflibercept biosimilars have also been launched in Europe including by Sandoz (Afqlir® launched in UK in November 2025) and Celltrion (Eydenzelt® launched in UK and EU in December 2025).  Settlement agreements between Regeneron/Bayer and other companies permit further 2026 EU biosimilar aflibercept launches, including for Alvotech and Biocon.