On 19 June 2026, Chugai Pharmaceutical (a Roche subsidiary) announced that the Japanese Ministry of Health, Labour and Welfare has approved Rituxan® (rituximab) for adult-onset frequently relapsing or steroid-dependent nephrotic syndrome, and Avastin® (bevacizumab) for treatment of neurofibromatosis type 2.  Avastin® is now the first drug approved in the world for the treatment of neurofibromatosis type 2.

Rituxan® was approved in Japan in August 2014 for paediatric-onset refractory nephrotic syndrome (frequently relapsing or steroid-dependent), in September 2024 for steroid-resistant paediatric-onset refractory nephrotic syndrome, and in March 2025 for paediatric-onset non-refractory frequently relapsing or steroid-dependent nephrotic syndrome.

Chugai currently co-promotes Rituxan® in Japan with Zenyaku Kogyo, which is the marketing authorisation holder.  However, in April 2026, Chugai and Zenyaku announced that they have terminated their co-promotion in Japan for Rituxan®, effective from 3 September 2026, at which time Zenyaku will assume sole responsibility for sales of Rituxan® in Japan.

Rituximab was one of the first mAbs to become “biosimilar”.  Both Pfizer and Sandoz/Kyowa Kirin market rituximab biosimilars in Japan.  Bevacizumab biosimilars have also been marketed in Japan for some time, including by Celltrion (Vegzelma™, launched January 2023) and Daiichi Sankyo/Amgen (bevacizumab BS for intravenous drip infusions, launched December 2019).

On 19 June 2026, The Asia Business Daily reported that Alteogen Biologics’ MENA region partner, SPIMACO, has received product approval for ALT-L9 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® (2 mg) from the Saudi Food and Drug Authority (SFDA).

The SFDA is a major regulatory agency in the Middle East and many MENA countries refer to SFDA approval results during their own regulatory review processes.  Alteogen therefore expects that the Saudi Arabian approval will expedite approval of ALT-L9 in other key MENA countries, including the United Arab Emirates, where regulatory review is underway.

ALT-L9 is the first biosimilar developed by Alteogen.  Alteogen entered into an exclusive agreement with SPIMACO in 2024 for the commercialisation rights to ALT-L9 in 16 MENA countries.

ALT-L9 was approved in Europe as Eyluxvi® in September 2025, following a positive CHMP opinion in July 2025.  In May 2026, Alteogen announced that the Korean Ministry of Food and Drug Safety had approved ALT-L9 as Eyzanfy™, 20 months after Alteogen had submitted its Korean marketing authorisation application in September 2024.

There are currently other established partnerships in relation to the commercialisation of aflibercept biosimilars in the MENA region.  This includes Formycon and MS Pharma, which partnered in May 2024 in relation to the commercialisation of Formycon’s FYB203 (aflibercept) in MENA, and Bioventure and Amman Pharmaceutical Industries, which entered into a licence agreement in 2023 under which Amman Pharma was granted exclusive rights to register and commercialise the Alvotech-developed aflibercept biosimilar in the Levant region.

On 18 June 2026, Samsung Bioepis and Organon announced the expansion of their development and commercialisation agreement for Canada to include Samsung Bioepis’ Pyzchiva® (SB17), biosimilar to J&J’s Stelara® (ustekinumab).  Current plans are for Pyzchiva® to be launched in Canada during 2026.

Under the terms of the expanded agreement, Organon will obtain the exclusive Canadian commercialisation rights to Pyzchiva®, while Samsung Bioepis retains full development, manufacturing, and regulatory responsibilities.

The new agreement expands the biosimilar portfolio under Samsung Bioepis and Organon’s collaboration in Canada (first established in 2013) from five to six biosimilars.  In addition to Pyzchiva®, the biosimilars encompassed by the agreement are Hadlima® (adalimumab; launched 50mg/mL in March 2021; 100mg/mL approved August 2022), Brenzys® (etanercept; approved September 2016), Renflexis® (infliximab; launched March 2018), Aybintio® (bevacizumab; launched November 2022), and Ontruzant® (trastuzumab; launched November 2022).

Samsung Bioepis had previously entered into an exclusive agreement with Sandoz in September 2023 for the development and commercialisation of SB17 in the US, Canada, EEA, Switzerland and the UK.  Sandoz launched Pyzchiva® in Europe in July 2024 and in the US in February 2025.

Pyzchiva® was approved in Canada in August 2024.  Other ustekinumab biosimilars approved and launched in Canada to date, include JAMP/Alvotech’s Jamteki® (approved November 2023, launched March 2024), Amgen’s Wezlana® (approved December 2023, launched March 2024), Celltrion’s Steqeyma® (approved July 2024, launched August 2024), Fresenius’ Otulfi® (approved January 2025, launched May 2025), Biocon’s Yesintek™ (approved October 2025, launched mid-October 2025) and Dong-A ST/Intas’ Imuldosa™ (approved January 2026, not yet launched).

On 18 June 2026, CSPC Pharmaceutical Group announced that China’s National Medical Products Administration (NMPA) has accepted its marketing authorisation application (MAA) for Secukinumab Injection, biosimilar to Novartis’ Cosentyx®.

Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.  According to the announcement, In phase 1 and 3 studies, CSPC’s biosimilar demonstrated high similarity to Cosentyx® in terms of efficacy, safety, pharmacokinetics, and immunogenicity.

This news follows Celltrion’s announcement earlier in June 2026 that it has filed an application for its secukinumab biosimilar (CT-P55) in Canada, seeking all approved reference indications.  Celltrion is planning additional regulatory filings for CT-P55 in the US, Europe and Korea.

Other secukinumab biosimilars are under development, including Bio-Thera’s BAT2306 (phase 1 trial completed in 2023, phase 3 clinical trial in plaque psoriasis completed in 2024, commercialisation agreement with Dr Reddy’s in November 2025), Taizhou Mabtech Pharmaceutical’s CMAB015 (phase 1 trial completed in 2023) and Livzon Pharmaceutical Group’s LZM012 (phase 3 clinical trial in plaque psoriasis commenced).

On 18 June 2026, Korea Biomed reported that South Korean-headquartered Alteogen has disclosed in an investor communication that a non-exclusive licence agreement it announced in November 2019 for its ALT-B4 technology with an “undisclosed” pharmaceutical company was a deal with Sanofi regarding development of a high-dose subcutaneous formulation of Dupixent® (dupilumab).  ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) designed to convert intravenous (IV) drugs into subcutaneous formulations.

The Sanofi deal was said by Alteogen in 2019 to potentially be worth up to USD 1.37 billion.  It has been disclosed that Sanofi paid USD13 million upfront in December 2019 and made two subsequent milestone payments, one in March 2020 for an undisclosed amount and a second of USD3 million in April 2023.  No details about the clinical stage of the development have been announced.

Alteogen has since partnered with a number of companies for the use of ALT-B4 in the subcutaneous formulations.  In November 2024, Alteogen signed an exclusive US$300 million licence agreement with Daiichi Sankyo for the development and commercialisation of a subcutaneous injection form of Enhertu® (trastuzumab deruxtecan).  In January 2026, Alteogen entered an exclusive licence agreement with Tesaro, a GSK subsidiary, for the use of ALT-B4 in the development and commercialisation of a subcutaneous formulation of dostarlimab.

Alteogen collaborates with MSD on subcutaneous Keytruda® (pembrolizumab).  MSD’s subcutaneous pembrolizumab was approved in the US, as Keytruda Qlex™, in September 2025 across 38 indications and has also been approved in Europe (November 2025), Canada (February 2026) and Korea (May 2026).

In January 2023, Alteogen entered into an exclusive agreement with Sandoz for the use of ALT-B4 to develop a subcutaneous version of an undisclosed Sandoz biosimilar product, with an option for Sandoz to licence the Alteogen technology for two further products.

On 17 June 2026, Sandoz announced the opening of its new biosimilar development centre in Ljubljana, Slovenia.  The construction of the fully digitally integrated USD 99 million facility was first announced in July 2025.

The centre will support end-to-end drug development and is fully integrated into the development network, including bioanalytical and bioassay laboratories in Holzkirchen, Germany and device development in Cambridge, UK.  The Slovenia biosimilar development centre is the first of three major investment projects in Slovenia, with Sandoz planning to invest a total of USD 1.1 billion across the three projects.

The new development centre joins Sandoz’s new facilities for drug production in Lendava, sterile production and packaging in Brnik and a biosimilar site acquired in Toulouse, France.  It follows Sandoz’s creation of a new global biosimilar development, manufacturing and supply unit, which came into effect on 1 April 2026.

According to Sandoz’s CEO, Richard Saynor, the new biosimilar development centre in Slovenia, together with Sandoz’s other manufacturing investments, will “help move biosimilars efficiently into production, supporting our ‘golden decade’ of more affordable healthcare, with approximately USD 320 billion in biologic patent expiries expected over the next decade”.

On 16 June 2026, Outlook Therapeutics announced that its resubmitted Biologics License Application (BLA) for ONS-5010/Lytenava™ (bevacizumab-vikg) has been accepted for review by the FDA.  The Prescription Drug User Fee Act (PDUFA) target date is 29 July 2026.

If approved, ONS-5010/Lytenava™ will be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA to treat wet AMD.  Outlook Therapeutics has commenced pre-launch activities in anticipation of the pending approval.

Since its initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA has issued three Complete Response Letters (CRL) to Outlook (in August 2023, August 2025 and December 2025).  After a Type A meeting in March 2026, Outlook requested a Formal Dispute Resolution (FDR) process.  In May 2026, the FDA granted the appeal, concluding that substantial evidence of effectiveness had been established for Lytenava™ for the treatment of wet AMD, despite the third CRL to the contrary.

Lytenava™ was approved in the EU in May 2024 and in the UK in July 2024.  It was launched in the UK and Germany in June 2025.

Intas Pharmaceuticals reportedly has an ophthalmic bevacizumab biosimilar under development, having received approval from India’s CDSCO in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 15 June 2026, Celltrion announced that it has launched its rituximab and bevacizumab biosimilars in Vietnam.  Truxima®, biosimilar to Roche/Genentech/Biogen’s Rituxan®/MabThera® (rituximab), and Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) were launched by Celltrion on 9 June 2026, following receipt of marketing authorisation three months earlier.

Celltrion now has four biosimilars on the market in Vietnam, having previously launched Remsima® (infliximab) and Herzuma® (trastuzumab) in August 2025.  Celltrion plans to leverage marketing synergies between the four products to accelerate prescriptions and is planning to introduce follow-up products into the Vietnamese market, including Remsima® SC.

Rituximab was one of the first mAbs to become “biosimilar”, being first approved in the US on 26 November 1997.  There are three rituximab biosimilars currently on the US market: Teva and Celltrion’s Truxima® (launched in May 2020), Pfizer’s Ruxience® (launched in January 2020) and Amgen and Allergan’s Riabni^TM (approved by the FDA in December 2020).

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017, with Mvasi® also being approved in Europe in January 2018.  There are currently five other bevacizumab biosimilars approved in the US: Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 2022), Celltrion’s Vegzelma™ (September 2022), Bio-Thera/Sandoz’s Avzivi® (December 2023), and Biocon Biologics’ Jobevne™ (April 2025).  More recently, on 13 January 2026, Shanghai Henlius Biotech announced that a Biologics Licence Application (BLA) for its bevacizumab biosimilar, HLX04, was accepted for review by the FDA.

On 12 June 2026, the FDA announced that it approved MSD’s Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with MSD’s Welireg® (belzutifan) for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

The FDA reviewed the combination under Project Orbis, an initiative of the FDA’s Oncology Center of Excellence that provides a framework for the collaborative review of new cancer treatments among international regulatory partners.  For this review, FDA collaborated with the Australian Therapeutic Goods Administration (TGA) and Health Canada.  The application reviews are ongoing at the other regulatory agencies.

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 12 June 2026, Amgen provided an update in relation to its phase 3 clinical trial for ABP 938 8 mg, biosimilar to Regeneron/Bayer’s Eylea HD® (aflibercept, 8 mg).

The clinical trial was commenced in May 2026 and aims to demonstrate similarity in efficacy between ABP 938 8 mg and US-sourced Eylea HD® by evaluating the change in best corrected visual acuity in patients with nAMD.  The trial is being conducted across 18 locations in the US and has an estimated completion date of January 2028.

Eylea HD® (‘high dose’), known as Eylea® 8 mg outside the US, was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2 mg and 8 mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

8 mg Eylea® has been approved to date in more than 60 markets for the treatment of nAMD and diabetic macular oedema (DME), including the US (August 2023).  It is also approved for the treatment of patients with macular oedema following retinal vein occlusion (RVO) including in the US (November 2025), Europe (January 2026), the UK (February 2026), Korea (February 2026) and Japan (March 2026).

Alvotech is developing a high dose aflibercept biosimilar, AVT29.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2 mg) in the US.  Alvotech indicated in March 2026 that it expects to file the first regulatory submission for AVT29 sometime in 2026.  In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated completion date of January 2028.