On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara®(ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease.  Stelara® is now the only FDA-approved IL-12/23 antagonist and the first non-TNF biologic to treat adults and children with moderately to severely active Crohn’s disease.

The approval is based on data from the Phase 3 UNITI-Jr clinical study, a multi-centre interventional study to evaluate the efficacy, safety, and pharmacokinetics of Stelara® for the treatment of paediatric Crohn’s disease over 52 weeks.

Stelara® is facing significant competition from biosimilars globally, including in the US, following settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in the US in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Samsung Bioepis’/Sandoz’s Pyzchiva® (February 2025), Celltrion (Steqeyma® launched March 2025) and Fresenius Kabi and Formycon (Otulfi® launched March 2025).  Other ustekinumab biosimilars launched in the US include Dong A-ST/Accord’s Imuldosa® (August 2025) and Bio-Thera/Hikma’s Starjemza™ (November 2025).

On 1 May 2026, Aurobindo announced that its subsidiary, CuraTeQ Biologics, received Canadian approval for Bevqolva™ (bevacizumab), biosimilar to Genentech’s Avastin®.  Bevqolva™ is indicated for various cancers and is available in 100 mg and 400 mg formulations.

CuraTeQ received approval for Bevqolva™ in the UK in December 2024 and the product is currently under regulatory review in Europe.

Bevacizumab biosimilars have been approved and available in Canada for many years, including Amgen’s Mvasi® (approved April 2018), Biocon’s Abevmy® (launched May 2022), Samsung Bioepis/Organon’s Aybintio® (launched November 2022) and Celltrion’s Vegzelma™ (approval announced January 2023).

The first bevacizumab biosimilar was approved in the US in September 2017 and in Europe in January 2018.

On 30 April 2026, Celltrion announced that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).

The timing of the application aligns with Celltrion’s December 2025 announcement that it had been conducting clinical trials for Herzuma® SC (CT-P6 SC) since February 2025 and planned to submit applications for approvals of the Herzuma® SC formulation to domestic and foreign regulatory agencies in the first half of 2026.  According to Celltrion, following the EMA, it plans to proceed with regulatory submissions for Herzuma® SC in other major countries.

There are currently no biosimilar SC formulations of trastuzumab on the market and Celltrion considers it is well-placed to enjoy a “first mover” advantage.  In January 2026, Biocon Biologics announced that it had added a trastuzumab/hyaluronidase product, referencing Roche’s Herceptin® SC/Herceptin Hylecta™, to its biosimilar development pipeline.

On 30 April 2026, Xbrane announced that it has resubmitted its BLA for biosimilar ranibizumab to the FDA following a Complete Response Letter (CRL) received in October 2025.  In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026.  However, following Xbrane’s contract manufacturer receiving “further detailed feedback from the FDA”, Xbrane’s resubmission plans were delayed.

The ranibizumab biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is th  subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialisation in the US.

There are currently three ranibizumab biosimilars approved in the US.  The first approved 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®.  It was launched in the EU in April 2023.

On 29 April 2026, Gedeon Richter announced that the European Commission has granted marketing authorisation for Tuyory ®, biosimilar to Roche’s RoActemra® (tocilizumab).  This follows a positive opinion for Tuyory® in February 2026 from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

Tuyory® is approved in IV and SC formulations for the treatment of rheumatoid arthritis (RA), systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), giant cell arthritis (GCA), cytokine release syndrome (CRS) and COVID-19.

Tuyory® was jointly developed by Gedeon Richter and Mochida Pharmaceutical, with Mochida being responsible for regulatory filings in Japan and Richter filing marketing authorisation applications in other countries.

There are 3 other tocilizumab biosimilars approved in Europe: Fresenius Kabi’s Tyenne® in both IV and SC forms (November 2023), STADA’s Tocilizumab STADA™ (previously Biogen’s Tofidence®) (June 2024) and Celltrion’s Avtozma® (February 2025).

Following the March 2026 launch of several generic equivalents of Novo Nordisk’s Ozempic® (semaglutide) in India and the “tentative approval” of Apotex’s generic semaglutide in the US, the first semaglutide generics have now been approved in Canada.

On 29 April 2026, Dr Reddy’s Laboratories announced that it was the first company to receive approval from Health Canada for its generic semaglutide injection for the treatment of type 2 diabetes in adults.  The approval covers two formulations: 2mg/pen (1.34mg/mL) and 4mg/pen (1.34mg/mL).  While no launch date has been announced, Dr Reddy’s has “launch plans underway”.

Days later, on 1 May 2026, Apotex announced that its Apo-Semaglutide Injection™ was approved by Health Canada.  The approval covers two prefilled pen formats: 0.25 mg or 0.5 mg doses (containing 2 mg of semaglutide 0.68mg/mL) and 1 mg doses (containing 4 mg of semaglutide 1.34 mg/mL).  Apo-Semaglutide Injection™ was developed by Apotex through a strategic partnership with Orbicular Pharmaceutical Technologies, headquartered in India.

Dr Reddy’s and Apotex are active in the generic semaglutide space, with Dr Reddy’s one of the first companies to receive approval for, and launch, generic semaglutide in India (under the name Obeda™) and Apotex receiving the first US FDA Tentative Approval for its generic semaglutide ANDA, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.

It has previously been reported that Health Canada is reviewing numerous submissions for generic semaglutide, including applications by Teva, Aspen Pharmacare, Taro Pharmaceuticals and Sandoz (which is planning a 2026 generic semaglutide launch in Canada).  Further generic semaglutide approvals are therefore expected in Canada in the coming weeks and months.

On 29 April 2026, the European Commission approved Shanghai Henlius and Organon’s Poherdy® (pertuzumab) as the first biosimilar to Genentech/Roche’s Perjeta®.

Poherdy® is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or locally recurrent unresectable breast cancer.  The approval follows the CHMP recommendation of 27 February 2026.

Under a June 2022 deal, Organon has exclusive global commercialisation rights for Henlius’ pertuzumab and denosumab biosimilars, “except for China; including Hong Kong, Macau and Taiwan”.

Roche and Genentech settled parallel BPCIA proceedings against Shanghai Henlius and Organon relating to Poherdy® in the US in January 2026.  Poherdy® was approved by the FDA in November 2025.

Pertuzumab biosimilars have been approved in India and include Intas’ biosimilar (December 2024, subject to submission of further studies), Zydus’ Sigrima™ (June 2024, subject to ongoing litigation) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) have been approved.  Pertuzumab biosimilars are also under development by Sandoz and EirGenix and, in February 2026, Genentech commenced US ITC proceedings against Biocon regarding its pertuzumab biosimilar, BMAB 1500.

On 28 April 2026, Celltrion announced the launch of Avtozma®/CT-P47, biosimilar to Roche’s Actemra®(tocilizumab), in Japan.  Avtozma® is the first tocilizumab biosimilar to be launched in Japan, having also been the first to receive approval in September 2025.

Avtozma® is approved for all reference indications and will be sold in Japan by Celltrion’s Japanese subsidiary.  Avtozma® has also received marketing authorisation in a number of other regions, including the US (January 2025), and was the first tocilizumab biosimilar approved in Australia (May 2025) and New Zealand (December 2025).

There is at least one other tocilizumab biosimilar approved in Japan, with Gedeon Richter/Mochida Pharmaceutical/Ayumi Pharmaceutical’s RGB-19 (marketed as Tuyory® in the EU) approved in March 2026 in IV, SC and autoinjector formulations.

At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:

• Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
• Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
• Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP;
• Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS;
• Amgen’s Wezlana® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion.

Amgen’s high concentration adalimumab biosimilar, Amgevita®, was TGA-approved in September 2025, while Celltrion’s high concentration adalimumab Yuflyma® was TGA-approved in September 2024, June 2023 and March 2022 as 20mg/0.2ml PFS, 80mg/0.8ml and 40mg/0.4ml, respectively.  Yuflyma® was first PBS-listed in March 2023 (40mg/0.4ml).  There are a number of other high concentration biosimilars to AbbVie’s Humira® approved in Australia, including Samsung Bioepis’ Hadlima® (approved February 2023, PBS-listed by Organon October 2024) and Sandoz’s Hyrimoz® (approved May 2024 and PBS-listed January 2025).

Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was previously PBS-listed on 1 August 2025 (in 75 mg/0.5ml and 150 mg/1ml PFS) and was launched in Australia in September 2025.  The March 2026 PBAC recommendation relates to the pre-filled pen presentation, which was TGA approved in August 2025.

Amgen’s Wezlana® (ustekinumab), biosimilar to Janssen’s Stelara®, was first recommended for PBS listing at PBAC’s April 2024 meeting.  However, Amgen did not proceed with the listing at that time and requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting.  PBAC has extended its March 2024 recommendation for a further 12 months, supporting the PBS listing of Wezlana®.

Sandoz’s Ardelya® (ustekinumab) has also been recommended for PBS listing but is yet to receive marketing approval in Australia.

Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025.  Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS listing at PBAC’s March 2025 meeting, but has not yet progressed to PBS listing, pending lodgement of required documentation.

On 27 April 2026, Jazz Pharmaceuticals announced that the FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) in combination with BeOne’s (formerly BeiGene’s) Tevimbra® (tislelizumab) and chemotherapy for the first-line treatment of adult patients with HER2+ advanced or metastatic gastric, gastroesophageal junction (GEJ), or gastroesophageal adenocarcinoma (GEA).

The sBLA is being reviewed under the FDA’s Real-Time Oncology Review (RTOR) program, which facilitates earlier submission of topline efficacy and safety results, prior to the submission of the complete application, to support an earlier start to the FDA’s evaluation of the application.  The FDA has set a target action date under the Prescription Drug Fee Act (PDUFA) of 25 August 2026.

The sBLA was based on positive safety and efficacy results from the global, randomised Phase III HERIZON-GEA-01 trial, which evaluated the efficacy and safety of Ziihera® in combination with standard-of-care chemotherapy with or without Tevimbra® in patients with advanced or metastatic GEA, including gastric, GEJ and oesophageal adenocarcinomas.

Jazz Pharmaceuticals also announced on 27 April 2026 that the FDA has granted Breakthrough Therapy designation to zanidatamab in combination with fluoropyrimidine- and platinum-containing chemotherapy, with or without tislelizumab, for the first-line treatment of patients with HER2+ unresectable locally advanced or metastatic gastric, GEJ, or oesophageal adenocarcinoma.

Zanidatamab is being developed by Jazz and BeOne under licence agreements from Zymeworks, which first developed the molecule.  Jazz has rights to zanidatamab in all regions except Asia (excluding India and Japan), Australia and New Zealand, for which BeOne has the rights.