On 28 February 2025, Outlook Therapeutics announced that it has resubmitted its Biologics Licence Application (BLA) to the US FDA for ONS-5010 (Lytenava™, ophthalmic bevacizumab-vikg) for the treatment of wet AMD.

The resubmission is based on positive results of the NORSE EIGHT clinical trial, announced in January 2025, which are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.  The study was conducted following Outlook’s receipt of a complete response letter (CRL) from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding further clinical trials.  Additional chemistry, manufacturing and controls (CMC) information requested by the FDA has also been included in the resubmission.

Lytenava™ was approved in the UK for wet AMD in July 2024 following submission of a marketing authorisation application to the MHRA under the International Recognition Procedure (IRP).  The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.  Lytenava™ is the first authorised ophthalmic formulation of bevacizumab in the EU.

On 19 February 2025, Shanghai Henlius Biotech announced that its HANBEITAI, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) under the trade name Longiva™.

This is the drug’s first approval outside China (approved December 2021), making it the fourth self-developed product from Shanghai Henlius Biotech to be marketed overseas.

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

On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for patients with recurrent respiratory papillomatosis, ocular conditions, liver cancer and advanced ovarian cancer.

Pharmac has also awarded Vegzelma® “principal supply status”, meaning it will be the main funded brand of bevacizumab in the New Zealand public health system until at least 31 August 2028.  All patients with recurrent papillomatosis are required to transition to Celltrion’s bevacizumab product by 1 August 2025, but “any brand” of bevacizumab will continue to be funded in public hospitals for patients with ocular conditions.

In the same announcement, Pharmac also reported that greater funding will be directed to Roche’s Tecentriq® (atezolizumab) for use in combination with bevacizumab for patients with liver cancer.

On 16 January 2025, Outlook Therapeutics announced 12-week results of its NORSE EIGHT clinical trial evaluating ONS-5010 (Lytenava™, ophthalmic bevacizumab) in wet AMD.  The results are said to show that ONS-5010 demonstrated non-inferiority to Genentech’s Lucentis® (ranibizumab) in terms of efficacy and safety.

The study was conducted following Outlook’s receipt of a Complete Response Letter from the FDA for ONS-5010 and its submission of a Special Protocol Assessment request in 2023 regarding additional clinical trials.  Based on the results of the NORSE EIGHT trial, Outlook plans to resubmit its Biologics Licence Application (BLA) for ONS-5010 to the US FDA in the first quarter of 2025.

Lytenava™ was approved in the UK for wet AMD in July 2024 following its submission to the MHRA under the International Recognition Procedure (IRP).  The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.  Lytenava™ is the first authorised ophthalmic formulation of bevacizumab in the EU.

On 21 December 2024, CuraTeQ Biologics announced that it has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Bevqolva™, biosimilar to Genentech’s Avastin® (bevacizumab).  Bevqolva™ is indicated for various cancers, including metastatic colorectal cancer, recurrent or metastatic non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell carcinoma, cervical cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer.

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

On 8 November 2024, Celltrion announced that it has achieved accumulated sales for Q3 2024 of KRW 2.4 trillion, surpassing its 2023 annual sales.  Its quarterly sales are the highest it has ever reported, up 31.2% year on year.

Celltrion attributes its sales growth to the expansion of global prescriptions for its subcutaneous infliximab, Remsima SC® (EU, launched in 2020)/Zymfentra™ (US, launched in March 2024), biosimilar adalimumab.  Yuflyma® (80mg dose US launch January 2024, 40mg dose first approved by the FDA in May 2023, launched 2023, paediatric form US launch March 2024), and biosimilar bevacizumab, Vegzelma® (US launch April 2023).  It has also experienced steady growth in its anticancer products, Truxima® (rituximab, US launch May 2020) and  Herzuma® (trastuzumab, US launch March 2020).

During 2024, Zymfentra™ secured all six public and private insurance contracts operated by the three major prescription drug managers (PBMs) in the US.  Celltrion estimates that it has now secured more than 90% coverage in the US insurance market by completing contracts with 30 mid- to large-sized and regional PBMs and insurance companies.

Celltrion also notes the expansion of its biosimilar portfolio during 2024 with the launch of SteQeyma® (ustekinumab) in major European countries on 1 November.  Celltrion is planning for the 2025 launch of Eydenzelt® (CT-P42, aflibercept).

Celltrion has a number of biosimilars under development, including CT-P41 (denosumab, US aBLA filed December 2023),  CT-P47 (tocilizumab), CT-P55 (secukinumab), CT-P53 (ocrelizumab) and CT-P51 (pembrolizumab).

Outlook Therapeutics’ ophthalmic formulation of bevacizumab, Lytenava™ (ONS-5010, bevacizumab gamma), has been recommended by the National Institute for Health and Care Excellence (NICE) as a NHS treatment option for wet age-related macular degeneration (AMD).

Lytenava™ was approved in the UK for wet AMD in July 2024 following its submission to the MHRA under the International Recognition Procedure (IRP).  The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.

Outlook Therapeutics is currently undertaking a clinical trial to assess the effectiveness of Lytenava™ for use in wet AMD for the purpose of resubmission of its Biologics Licence Application to the US FDA.  This follows receipt of a Complete Response Letter from the FDA and submission of a Special Protocol Assessment (SPA) request in 2023.

On 30 October 2024, Biocon Limited announced its financial results for Q3 2024, reporting that while its total consolidated revenue was flat (year on year), it experienced “robust performance” in its biosimilars business with growth of 19% (year on year).  Biocon attributes the biosimilar growth to an increase in market share in the US, expansion in Europe and 15 new launches in emerging markets.

Biocon reports that its oncology franchise, including Ogivri® (biosimilar trastuzumab, US launch in December 2019) and Fulphila® (biosimilar pegfilgrastim, US approval in June 2018), has experienced an increase in market share over the quarter (YoY), with the market share for Ogivri® increasing from 11% to 18% and that for Fulphila® increasing from 15% to 21%.  Biocon’s insulin products have also grown in market share with unbranded bGlargine and Semglee® (insulin glargine-yfgn) surpassing 15%.

Biosimilar highlights for the third quarter include the EMA’s validation of Biocon’s application for biosimilar denosumab and Biocon’s settlement and licence agreement in August 2024 for Yesintek™ (Bmab 1200), biosimilar to Janssen’s Stelara® (ustekinumab), permitting Biocon to launch in Europe, the UK, Canada and Japan following regulatory approval.  Biocon had previously entered a settlement agreement with Janssen in relation to ustekinumab in May 2024, allowing US launch in February 2025.  The FDA accepted Biocon’s BLA for Bmab 1200 for review under the 351(k) pathway in May 2024.

In emerging markets, Biocon specifically refers to launches of biosimilar bevacizumab and pegfilgrastim in Saudi Arabia and regulatory approvals for biosimilars of bevacizumab, etanercept, adalimumab, insulin aspart and rh-insulin in several countries in the Latin American, African and Middle East regions.

Biocon’s licensing and supply agreement with Tabuk Pharmaceutical for commercialisation of its GLP-1 products for diabetes and chronic weight management in certain Middle East countries and its exclusive distribution and supply agreement with a leading pharmaceutical company in Brazil (October 2024) for commercialisation of liraglutide (generic of Novo Nordisk’s Victoza®/Saxenda®) are also said to be Q3 2024 highlights.

On 6 September 2024, Celltrion’s CEO, Seo Jin-seok, announced at the 22^nd Morgan Stanley Global Healthcare Conference that it plans to obtain approval for 11 biosimilar products by 2025, with an aim to have a “portfolio of 22 products by 2030”.

Celltrion has 8 biosimilars approved in various jurisdictions, namely omalizumab, ustekinumab, adalimumab, aflibercept, rituximab, trastuzumab, bevacizumab, and SC infliximab, and has biosimilar pembrolizumab, secukinumab and denosumab in clinical trials.

According to a report by Korea Economic Daily on 12 September 2024, Celltrion also has plans to establish and build a wholly owned contract development and manufacturing organisation (CDMO) plant with a capacity of 180,000 litres and production lines for antibody-drug conjugates, including Zymfentra^™/Remsima SC® (SC infliximab).

On 4 September 2024, Outlook Therapeutics announced that it has completed patient enrolment in its NORSE EIGHT clinical trial assessing the effectiveness of ONS-5010/Lytenava™ (bevacizumab-vikg, bevacizumab gamma) for use in wet AMD.  The trial is the final step required before expected resubmission of Outlook Therapeutics’ Biologics License Application (BLA) for ONS-5010 in the US, following receipt of a Complete Response Letter from the FDA, and submission of a Special Protocol Assessment (SPA) request, in 2023.  The drug has the potential to be the first US-approved ophthalmic formulation of bevacizumab.

Lytenava™ was approved in the UK for wet AMD in July 2024 following its submission to the MHRA under the International Recognition Procedure (IRP).  The UK approval followed marketing authorisation granted to Lytenava™ in the EU in May 2024.