On 24 July 2026, Outlook Therapeutics announced that the FDA has approved ONS-5010/Lytenava™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (nAMD/wet AMD).  Outlook expects Lytenava™ will be available to eligible patients in the US before the end of 2026.

Lytenava™ is the first and only FDA-approved ophthalmic formulation of bevacizumab for the treatment of nAMD.  Outlook Therapeutics considers that Lytenava will have 12 years of Reference Product Exclusivity under the US BPCIA.

Since Outlook’s initial BLA submission for ONS-5010/Lytenava™ in 2022, the FDA 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.  The FDA accepted Outlook’s resubmitted Biologics License Application for Lytenava™ in June 2026 with a Prescription Drug User Fee Act target date of 29 July 2026.

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 7 July 2026, Celltrion announced that it has successfully secured formulary listings for Vegzelma™, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), with two major pharmacy benefit managers (PBMs) in the US.

Vegzelma™ was listed as a preferred drug on the government and commercial insurance formularies of Express Scripts (ESI) and on the government insurance formulary of Optum.  Reimbursement coverage for ESI and Optum’s government insurances came into effect on 1 July 2026, with coverage for ESI’s commercial insurance expected to come into effect in January 2027.

Vegzelma™ was approved by the FDA in September 2022.  According to Celltrion’s announcement, as of May 2026, Vegzelma™ had captured over 10% market share of the US bevacizumab sector through the open market, and it has now “secured coverage across more than 35% of the US insurance market” through the PBM formulary listings.

There are currently five other bevacizumab biosimilars approved in the US: Amgen’s Mvasi® (September 2017), Pfizer’s Zirabev® (June 2019), Amneal’s Alymsys® (April 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 for its bevacizumab biosimilar, HLX04, was accepted for review by the FDA.

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 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 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for ONS-5010/Lytenava™ (bevacizumab-vikg) for wet AMD.  The FDR process is an appeal mechanism that permits a sponsor to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision.

In December 2025, the FDA issued a Complete Response Letter (CRL) for the second resubmission of ONS-5010/Lytenava™, recommending that additional confirmatory evidence be provided to support Outlook’s application, though it did not clarify what type of evidence would be acceptable.  Outlook subsequently attended a Type A meeting with the FDA in March 2026 to discuss the CRL and then submitted its Formal Dispute Resolution Request in April 2026.

In its appeal decision, the FDA concluded that substantial evidence of effectiveness has been established for Lytenava™ for the treatment of wet AMD, despite the earlier CRL.  The decision directs the FDA’s Division of Ophthalmology (Division) and Office of Specialty Medicine (OSM) to work with Outlook Therapeutics to reach agreement on final labelling.

Outlook Therapeutics expects to resubmit the BLA for ONS-5010/Lytenava™ in June 2026.  If approved, ONS-5010/Lytenava™ would be the first ophthalmic formulation of bevacizumab-vikg approved by the FDA.

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 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 7 April 2026, Outlook Therapeutics announced that it has submitted a formal dispute resolution request (FDRR) to the FDA following a Type A meeting in March 2026 in relation to its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The FDRR is an appeal process which permits a sponsor to obtain formal review of any FDA decision by raising the matter with the supervisor of the employee who made the decision.  The FDA has accepted Outlook’s  FDRR and has scheduled a meeting with the deciding official in April 2026.

The March 2026 Type A meeting was held to clarify an issue identified in a Complete Response Letter issued by the FDA in December 2025 regarding the second resubmission of Outlook’s Biologics Licence Application (BLA) for ONS-5010/Lytenava™.  In the CRL, the FDA had recommended that additional confirmatory evidence be provided to support the application, though it did not clarify what type of evidence would be acceptable.

In its April 2026 press release, Outlook Therapeutics reiterated that it remains committed to its position “that data on safety and efficacy for Lytenava™ demonstrated in NORSE TWO and NORSE EIGHT provide sufficient evidence to support approval”.

Outlook Therapeutics received a first CRL from the FDA for Lytenava™ in August 2023 and subsequently submitted a Special Protocol Assessment request in December 2023 regarding further clinical trials.  It resubmitted its BLA to the FDA in February 2025 based on positive results of the NORSE EIGHT clinical trial, announced in January 2025.  A second CRL (issued in August 2025) recommended that Outlook submit additional efficacy data to support its application for Lytenava™.  Outlook resubmitted its BLA to the FDA for a second time in early November 2025.

Lytenava™ was approved in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025.  The Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland 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 24 March 2026, Singapore-headquartered Prestige Biopharma announced that it is “accelerating commercialisation” of Vasforda®/HD204, biosimilar to Genentech’s Avastin® (bevacizumab), following positive results from its global Phase 3 clinical trial.  The trial was conducted in patients with advanced non-squamous non-small cell lung cancer (NSCLC) and reportedly demonstrated clinical equivalence between Vasforda®/HD204 and Avastin®.

Under an agreement announced in July 2022, Prestige granted exclusive commercialisation rights for HD204 to Intas & Accord Healthcare for the US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.  According to Prestige, in collaboration with Accord Healthcare, it has been preparing regulatory submissions for US and European markets, with marketing authorisation applications for HD204 expected to be submitted in H2 2026.

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 included in the FDA’s approved drugs database: 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 5 March 2026, Outlook Therapeutics provided an update on ONS-5010/Lytenava™, ophthalmic biosimilar to Roche/Genentech’s Avastin® (bevacizumab-vikg), following a Type A meeting with the U.S. Food and Drug Administration (FDA).

The Type A meeting was held to clarify an issue regarding substantial evidence of effectiveness identified in the third Complete Response Letter (CRL) issued in December 2025 for the ONS-5010/Lytenava™ Biologics License Application (BLA).  The meeting was also used to discuss potential regulatory approval steps.  Outlook Therapeutics stated it will continue to engage with the FDA to further clarify the FDA’s view on confirmatory evidence and the regulatory path forward.

The March 2026 Type A meeting is the second Type A meeting Outlook Therapeutics has held with the FDA for its ophthalmic bevacizumab biosimilar.  The first Type A meeting occurred in September 2025 to address the second CRL issued in August 2025.  The CRL recommended that Outlook Therapeutics submit additional confirmatory efficacy data to support its application.

Outlook Therapeutics had already resubmitted its BLA to the FDA in February 2025, following receipt of a first CRL from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.  A second CRL (August 2025) recommended Outlook submit additional efficacy data to support its application for ONS-5010. Outlook Therapeutics resubmitted its BLA to the FDA in November 2025, in order to address the issues in the August 2025 CRL.

Lytenava™ received marketing authorisation in the EU in May 2024 and was launched in the UK and Germany for wet AMD in June 2025.  The Scottish Medicines Consortium also accepted Lytenava™ for use within NHS Scotland in June 2025.

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