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

On 19 February 2026, Outlook Therapeutics announced that it has entered into an exclusive commercial distribution agreement with Mediconsult for Lytenava™ (ONS-5010, bevacizumab-vikg/bevacizumab gamma) in Switzerland.

Under the agreement, Mediconsult has exclusive rights to market, import, distribute, commercialise and maintain regulatory affairs for Lytenava™ in Switzerland, whilst Outlook Therapeutics is responsible for the manufacture and supply of the product.  Outlook Therapeutics expects Lytenava™ to be available in Switzerland in 2027, subject to regulatory approval.

Lytenava™ is the first and only authorised ophthalmic formulation of bevacizumab in the EU and UK.  It received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024.  Lytenava™ was launched in June 2025 in the UK and Germany for treatment of wet AMD.  The Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland in June 2025.

Outlook Therapeutics received a Complete Response Letter (CRL) from the FDA in December 2025 following a second resubmission of its Biologics Licence Application for Lytenava™.  On 11 February 2026, Outlook Therapeutics announced that it had submitted a Type A meeting request with the FDA.

There is at least one ophthalmic bevacizumab biosimilar under development.  In March 2025, Intas Pharmaceuticals received approval from India’s CDSCO to conduct Phase 2/3 trials for bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 13 January 2026, Shanghai Henlius Biotech announced that its Biologics Licence Application (BLA) for HLX04, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has been accepted for review by the FDA.

HLX04 has previously been approved in China (2021) and in multiple Latin American countries, including Bolivia, the Dominican Republic, and Mexico.  In October 2020, Henlius entered into a co-development and exclusive licensing agreement with Hong Kong-headquartered EssexBio, under which EssexBio was granted an exclusive licence to develop, manufacture and commercialise HLX04 globally.

The first bevacizumab biosimilar approved in the US was Amgen’s Mvasi® in September 2017.  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).

Henlius also has an ophthalmic preparation based on HLX04 under development, which is intended for the treatment of wet AMD.  In August 2025, a new drug application for Henlius’ ophthalmic bevacizumab biosimilar, HLX04-O, was accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration.

On 31 December 2025, Outlook Therapeutics announced that the FDA issued a Complete Response Letter (CRL) regarding the second resubmission of its Biologics Licence Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The CRL comes 7 weeks after the FDA accepted Outlook’s second resubmission of its BLA for Lytenava™ in November 2025.  In the CRL, the FDA indicated that the mechanistic and natural history data added in the BLA resubmission did not alter its earlier assessment.  While the FDA acknowledged that the single adequate and well-controlled study demonstrated efficacy, it again recommended that additional confirmatory evidence be provided to support the application, though did not clarify what type of evidence would be acceptable.

Bob Jahr, CEO of Outlook Therapeutics, stated that while Outlook is “disappointed and disagree[s] with this decision”, they are “fully committed to taking all necessary steps to receive approval in the United States”.

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 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™ for wet AMD.

The acceptance follows the resubmission of the BLA earlier this month after the company’s Type A meeting with the FDA in September 2025 to address the Complete Response Letter (CRL) issued in August 2025.  According to Outlook, the FDA has advised that it considers the BLA resubmission a complete, Class 1 response to the August 2025 action letter, which results in a 60-day review period from the date of resubmission.  As a result, the FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 31 December 2025.

Outlook had previously 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.

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 in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 3 November 2025, Outlook Therapeutics announced that it has re-submitted its Biologics Licence Application (BLA) to the US FDA for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.

The resubmission follows the company’s Type A meeting with the FDA in September 2025 to address the Complete Response Letter (CRL) issued in August 2025.  Outlook Therapeutics “believe[s] this resubmission will resolve the outstanding issue highlighted” in the August 2025 CRL.

Outlook 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.

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 in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

On 30 October 2025, Celltrion announced that, according to IQVIA, its Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), has achieved 50% market share in Japan, surpassing competing innovator and biosimilars to become that top bevacizumab product.  Celltrion states that Vegzelma® has more than tripled its market share, which stood at 15% the same time last year.

Vegzelma®’s success follows that of Celltrion’s other oncology biosimilar, Herzuma®, referencing Roche’s Herceptin® (trastuzumab), which holds a 74% market share in Japan.  Celltrion further reports that its autoimmune disease portfolio has shown strong performance, with Remsima®, referencing Janssen’s Remicade® (infliximab), and Yuflyma®, referencing AbbVie’s Humira® (adalimumab), achieving market shares of 43% and 14%, respectively.

Celltrion attributes this growth to the success of its localised sales and distribution strategy, tailored to Japan’s Diagnosis Procedure Combination (DPC) system, a reimbursement framework that encourages the use of cost-effective medicines such as biosimilars.

In September 2025, Celltrion announced that its Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), became the first biosimilar tocilizumab approved in Japan.  This followed the Japanese launch of Celltrion’s biosimilar ustekinumab, Steqeyma®, referencing J&J/Janssen’s Stelara®, in July 2025.

On 29 September 2025, Outlook Therapeutics announced that it has completed a Type A Meeting with the FDA to discuss the August 2025 complete response letter (CRL) declining Outlook’s BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for wet AMD.  Following “a productive discussion with the FDA”, Outlook “expects to resubmit its BLA before the end of calendar year 2025”.

Outlook has already resubmitted its BLA to the FDA once, 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.

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 in March 2025 to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal injection 25mg/mL) in patients with wet AMD.

New Zealand’s drug funding agency, Pharmac, has opened for public consultation a provisional agreement with Roche to fund a package of Roche drugs, including subcutaneous formulations of biologics previously only funded as IV treatments.  The agreement includes the following biologics:

• Avastin® (bevacizumab) for ocular conditions only. This represents a rare example of Pharmac funding two suppliers’ brands of the same biologic.  Celltrion’s bevacizumab biosimilar, Vegzelma®, was awarded Principal Supply Status for all reference indications by Pharmac in February 2025.  However, the agreement with Celltrion specifically allowed other brands to be funded for ocular conditions only.
• Ocrevus® SC (ocrelizumab), alongside IV Ocrevus®. Most patients are expected to switch to Ocrevus® SC.  No ocrelizumab biosimilars have been submitted for approval in New Zealand to date.
• Phesgo® (pertuzumab and trastuzumab) for subcutaneous treatment of HER2-positive metastatic breast cancer. Roche’s Perjeta® (pertuzumab) and Celltrion’s Herzuma® (biosimilar trastuzumab) are already funded as separate IV infusions for people with HER2-positive metastatic breast cancer.  It is expected that most patients receiving these in combination will now receive Phesgo® as it can be administered faster than the IV infusions, providing the same treatment benefit with less time spent receiving treatment.
• Vabysmo® (faricimab) for diabetic macular oedema and wet age-related macular degeneration. Funding criteria will be the same as updated criteria for aflibercept (Regeneron’s Eylea®).  Criteria for funding ranibizumab are also being updated.
• Gazyva® (obinutuzumab) and MabThera® (rituximab) will have funding criteria updated. No MabThera® biosimilar is currently funded for rheumatoid arthritis to date due to Roche patent protection subsisting in New Zealand for that indication.  Sandoz’s biosimilar rituximab, Riximyo®, is funded for all other (off-patent) indications.

Submissions on the provisional agreement may be made until 5.00pm 8 October 2025 (NZ time).

On 28 August 2025, Outlook Therapeutics announced that the US FDA issued a complete response letter (CRL) declining its BLA resubmission for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™, for treating wet age-related macular degeneration (wet AMD).

Outlook Therapeutics resubmitted its BLA 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.

In this latest setback, the FDA recommended Outlook Therapeutics submit additional efficacy data to support its application for ONS-5010.  Outlook intends “to meet with the FDA to receive additional clarity on their requirements to potentially approve the first on-label bevacizumab product specifically formulated, manufactured, and packaged for intravitreal use in the United States”.

In June 2025, the Scottish Medicines Consortium accepted Lytenava™ for use within NHS Scotland for the treatment of wet AMD.  In the same month, Outlook Therapeutics announced that it had launched Lytenava™ in the UK and Germany for wet AMD.

Lytenava™ received marketing authorisation in the EU in May 2024 and was approved in the UK in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).

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.