On 29 October 2025, Samsung Bioepis announced that it has entered into an Asset Purchase Agreement with Biogen in Europe for Samsung Bioepis’ two ophthalmology biosimilars: Byooviz® (biosimilar to Genentech’s Lucentis® (ranibizumab)) and Opuviz™ (biosimilar to Regeneron/Bayer’s Eylea® (aflibercept)).

Samsung Bioepis and Biogen had partnered in November 2019 in relation to commercialisation of the two ophthalmology biosimilars in the US, Canada, Europe, Japan and Australia.  In October 2024, Biogen decided to terminate the November 2019 agreement with Samsung Bioepis within the US and Canada.  In July 2025, Samsung Bioepis entered into an agreement with Harrow, under which Harrow will assume full commercial responsibility for Byooviz® and Opuviz™ in the US upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Under the Asset Purchase Agreement announced this week, Samsung Bioepis will be responsible for commercialising Byooviz® in Europe from January 2026 once the transfer of commercial rights from Biogen back to Samsung Bioepis takes effect.  Samsung Bioepis will launch Opuviz™ in Europe following the lapse or revocation of relevant patent(s) for Eylea®.

Byooviz® has been commercially available in several European countries since March 2023, following its approval in August 2021 as the first ophthalmology biosimilar in the region for the treatment of patients with nAMD, macular oedema following retinal vein occlusion (RVO), and myopic choroidal neovascularisation (mCNV).  Other EU approved ranibizumab biosimilars include Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva), Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (approved November 2022).

There are currently 10 aflibercept biosimilars approved in Europe:  Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), Amgen’s Pavblu® (April 2025), Alvotech/Advanz’s Mynzepli® (August 2025) and Alteogen’s Eyluxvi® (September 2025).  Sam Chun Dang announced on 20 August 2025 that its aflibercept biosimilar received EU marketing authorisation, although the name of the product is not yet known.

On 27 October 2025, China Medical System Holdings Limited announced that its subsidiary, CMS Vision International Management Limited, has entered into a distribution agreement with Novartis Pharma Services AG for Lucentis® (ranibizumab) and Beovu® (brolucizumab).

Under the agreement, CMS has the exclusive rights to import, distribute, sell and promote Lucentis® and Beovu® in the People’s Republic of China for a five-year term.  Novartis will continue to be responsible for the production and supply of the products.  Both Lucentis® and Beovu® are approved for marketing in China, with Lucentis® being the first anti-vascular endothelial growth factor (VEGF) drug approved for ophthalmic use in China.

There are a number of ranibizumab biosimilars approved across global markets.  Formycon/Teva’s FYB201/Ranivisio® was first approved in Europe in August 2022, and was developed by Bioeq (a joint venture between Formycon and Polpharma Biologics), and has been commercialised in the region in vial and PFS form, by Teva since 2022 and 2025, respectively.  It was approved in the UK (in May 2022, marketed as Ongavia® by Teva), the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).  Other approved ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021, FDA-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved in November 2022).

On 21 October 2025, African biotechnology company Bio Usawa announced that the Rwanda Food and Drugs Authority has granted market approval for its BioUcenta™, biosimilar to Genentech’s Lucentis® (ranibizumab), making the product the first ranibizumab biosimilar approved in Africa.

Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, entered into an exclusive partnership with Bio Usawa for the commercialisation of FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics), and has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).

On 21 October 2025, Xbrane announced that the FDA has issued a Complete Response Letter (CRL) regarding its biosimilar ranibizumab, referencing Genentech’s Lucentis®.  The CRL follows the December 2024 resubmission of the BLA after the FDA issued a first CRL in April 2024 identifying issues relating to (a) the analytical methods for the reference standard; and (b) pre-approval inspections of manufacturing partner’s sites.

According to Xbrane, the “FDA conducted re-inspections during Q3 2025 of both production sites involved in production of drug substance and drug product respectively.  Thorough evidence on corrective actions to the respective observations was submitted by both production sites in due time to the FDA.”  However, in the latest CRL, the FDA refers to unresolved observations following the inspection at one of the production sites without further specification, with no other issues related to the BLA mentioned.

In the October announcement, Xbrane also says that it and its contract manufacturers “are now awaiting further communication from FDA” and will work with the production site to resolve the issues and allow re-submission of the BLA as soon as possible.

The biosimilar is co-developed by Xbrane and STADA pursuant to a 2018 agreement, and is the subject of an exclusive licensing agreement with US biosimilars specialist Valorum Biologics, who will be responsible for commercialisation in the US under the Lucamzi™ brand.

There are currently two ranibizumab biosimilars approved in the US.  The first approved was Samsung Bioepis’ Byooviz® (September 2021), which was followed by Formycon/Sandoz’s Cimerli® (August 2022).

On 21 October 2025, Formycon and Teva jointly announced the European launch of FYB201/Ranivisio®, biosimilar to Genentech’s Lucentis® (ranibizumab), in pre-filled syringe (PFS) presentation.  The product is the first biosimilar ranibizumab to be offered in a PFS presentation in Europe, and will launch first in France this month, with additional countries, including Germany, to follow in a staggered approach.

FYB201/Ranivisio® was first approved in Europe in August 2022, and was developed by Bioeq (a joint venture between Formycon and Polpharma Biologics), and has been commercialised in the region in vial, and now PFS form, by Teva since 2022.  It was approved in the UK (in May 2022, marketed as Ongavia® by Teva), the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).

Other approved ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021, FDA-approved in September 2021); Lupin’s biosimilar (being marketed in the EU by Sandoz); and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

On 20 October 2025, Santen Pharmaceutical announced that Santen Korea has entered into a promotion and distribution agreement in South Korea with Novartis Korea.  The agreement covers Novartis’ Beovu® (brolucizumab) and Lucentis® (ranibizumab), which will be exclusively distributed and promoted by Santen in South Korea.  The deal marks Santen’s first entry into the retinal disease market in South Korea.

Santen Korea’s promotion and distribution agreement precedes Novartis’ distribution agreement with Chinese Medical Systems Holdings regarding commercialisation of the two products in China, which was announced on 27 October 2025.

There are a number of ranibizumab biosimilars approved around the world.  Formycon/Teva’s FYB201/Ranivisio® was first approved in Europe in August 2022, was developed by Bioeq (a joint venture between Formycon and Polpharma Biologics), and has been commercialised in the region in vial and PFS form by Teva since 2022 and 2025, respectively.  It was approved in the UK (in May 2022, marketed as Ongavia® by Teva), the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (in March 2024, marketed as Ravegza® by MS Pharma).

Other approved ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021, FDA-approved in September 2021), Lupin’s biosimilar (being marketed in the EU by Sandoz), and STADA/Xbrane’s Ximluci® (EU-approved in November 2022).

On 12 August 2025, Lupin announced that it has partnered with Sandoz to market and commercialise Lupin’s biosimilar ranibizumab (referencing Genentech’s Lucentis®) across the European Union (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam, and Malaysia.  

Sandoz has exclusive marketing rights in most of the designated markets, except for France, Australia, Vietnam, and Malaysia, where it has semi-exclusive marketing rights.  Lupin remains responsible for manufacturing the product and for regulatory submissions.

Lupin is one a of a number of companies with ranibizumab biosimilars.  Other ranibizumab biosimilars include Samsung Bioepis’ Byooviz® (EU-approved in September 2021, FDA-approved in September 2021); Formycon’s Ranivisio® (EU-approved in August 2022); Sandoz’s Cimerli® (FDA-approved in August 2022) and STADA/Xbrane’s Ximluci® (EU-approved 9 November 2022).

On 17 July 2025, Samsung Bioepis announced that it has entered into a licence, development and commercialisation agreement with eyecare pharmaceutical company, Harrow, in relation to Samsung Bioepis’ US ophthalmology portfolio.  The agreement follows Biogen’s October 2024 decision to terminate its November 2019 agreement with Samsung Bioepis, within the US and Canada, for commercialisation of Samsung Bioepis’ ophthalmology biosimilars.

Under the new agreement, Harrow will assume full commercial responsibility in the US for Samsung Bioepis’ Byooviz® (ranibizumab-nuna), biosimilar to Genentech’s Lucentis®, and Opuviz® (aflibercept-yszy), biosimilar to Regeneron’s Eylea®, upon full transition of Biogen’s commercialisation rights back to Samsung Bioepis by the end of 2025.

Opuviz® was the first FDA approved interchangeable aflibercept biosimilar (with Biocon’s Yesafili™) in May 2024.  The US launch date for the product remains uncertain due to ongoing patent litigation brought by Regeneron against Samsung Bioepis (amongst others) regarding aflibercept.  A preliminary injunction was granted, and remains in place, preventing Opuviz®’s US launch (14 June 2024, upheld on appeal on 29 January 2025).

Byooviz® was FDA approved in September 2021, launched in the US on 2 June 2022 and approved as interchangeable to Lucentis® across all approved indications in October 2023.

On 1 July 2025, Formycon announced that Bioeq AG, which holds the exclusive worldwide commercialisation rights for Formycon’s FYB201, biosimilar to Genentech’s Lucentis® (ranibizumab), has entered into an exclusive partnership with African biotechnology company Bio Usawa Biotechnology Ltd.  The partnership gives Bio Usawa the exclusive rights to commercialise FYB201 under the brand name BioUcenta™ in Sub-Saharan Africa.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (marketed as Ravegza® by MS Pharma).

Last month, Brazil’s ANVISA had granted marketing authorisation for Ranivisio® (FYB201), with an expected launch in Q4 2025 by Formycon’s commercialisation partner, Biomm, and then a phased market rollout of Ranivisio® across Latin America.  Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab).

Formycon expects that Ranivisio® will be launched in Brazil in Q4 2025 by its commercialisation partner, Biomm, with a phased market rollout of Ranivisio® to follow across Latin America.  Marketing authorisations have previously been granted in Peru, El Salvador, Honduras and the Dominican Republic and further approvals in Central and South America are planned.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics).  It has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli®, to which Sandoz acquired the marketing rights from Coherus in March 2024), the EU (in August 2022, marketed as Ranivisio® by Teva), Canada (in December 2023, marketed as Ranopto™ by Teva) and MENA (marketed as Ravegza® by MS Pharma).