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.

On 21 August 2025, BioDlink (previously known as TOT BIOPHARM) announced that its Bevacizumab Injection, biosimilar to Roche/Genentech’s Avastin®, has received marketing approval from Indonesia’s National Agency of Drug and Food Control (BPOM).

This news comes just days after BioDlink’s 13 August 2025 announcement that its biosimilar bevacizumab received marketing approval from Pakistan’s Drug Regulatory Authority of Pakistan (DRAP) and Colombia’s National Institute for Surveillance of Medicines and Foods (INVIMA).

BioDlink’s manufacturing facility has received GMP certification in China, Colombia, Brazil, Argentina, Egypt, Indonesia and Pakistan and its global licensee for the bevacizumab biosimilar in emerging markets, Kexing Biopharm, has initiated regulatory filings in 35 countries.

On 13 August 2025, Shanghai Henlius and Hong Kong-headquartered EssexBio announced that China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted for review their New Drug Application (NDA) for HLX04-0, an ophthalmic preparation product based on Henlius’ biosimilar to Roche/Genentech’s Avastin® (bevacizumab).  HLX04-O is intended for the treatment of wet AMD.

The companies entered into a co-development and exclusive licensing agreement in October 2020, under which EssexBio was granted an exclusive licence to develop, manufacture and commercialise HLX04 (biosimilar bevacizumab) globally.

The first and only authorised ophthalmic formulation of bevacizumab in the EU and UK, Lytenava™ (bevacizumab gamma, ONS-5010), which received EU approval in May 2024 and UK approval in July 2024, was launched in the UK and Germany in June 2025 by Outlook Therapeutics.  In the US, the product is still under regulatory consideration, with Outlook Therapeutics having resubmitted its BLA to the FDA in February 2025, after receiving a complete response letter in 2023.

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 21 July 2025, Samsung Bioepis published its US Biosimilar Market Report, which has been released every quarter since April 2023.  The report details average sales price (ASP) and wholesale acquisition cost (WAC) information for commercially available biosimilars in the US.

The Q3/2025 edition reports that, as of June 2025, the FDA has approved 75 biosimilars, with 52 of those launched.  On average, the ASP of biosimilars remained 20-30% lower than reference biologics, with increased discounts in crowded markets, such as those for adalimumab and ustekinumab.

The biosimilars US-approved in Q3 were Bio-Thera’s Starjemza® (ustekinumab, May 2025) and Biocon’s Jobevne^™ (bevacizumab, April 2025).  Biosimilars with US launches in Q3 were Sandoz’s Jubbonti® and Wyost® (denosumab, June 2025) and Samsung Bioepis/Teva’s Epysqli® (eculizumab, April 2025).

According to the Report, biosimilars in the US have gained an average of 52% market share within 5 years post initial launch.  However, some biosimilar markets have faster uptake speeds than others; in particular, oncology, ophthalmology and pegfilgrastim biosimilars reached an average of 81% market share 5 years post launch.

In a “Biosimilar Deep Dive”, the Samsung Bioepis Report considers potential implications of the US Government’s most favoured nation (MFN) policy on the US biosimilars market.  The MFN policy aims to reduce drug costs by ensuring access to the lower prices typically paid by similar nations.  The Report concludes that, although there remains uncertainty regarding MFN implementation, the policy may result in a smaller market, reducing commercial opportunities for biosimilars to enter and compete effectively and discouraging biosimilar manufacturers from investing in new products.

On 2 July 2025, Navlin Daily reported that the Spanish Ministry of Health issued a tender for the sustainable supply of biologics and biosimilars under a two-year Framework Agreement worth €411 million coordinated by the Instituto Nacional de Gestión Sanitaria (INGESA).

According to the report, this second-phase agreement builds upon the initial framework launched in late 2022, which generated over €120 million in cost savings to date.  The new agreement is expected to deliver an additional €178 million in savings and will comprise 17 therapeutic categories covering biologics that have approved biosimilars.  The Framework Agreement includes the following biologics, among others: adalimumab, etanercept, infliximab, rituximab, trastuzumab, pegfilgrastim, bevacizumab, tocilizumab, natalizumab, eculizumab, ranibizumab and ustekinumab.

INGESA will select between 25 and 50 suppliers using an open procedure, with contracts awarded based on 70% price and 30% quality weighting.