On 1 November 2025, HITNews reported that Samsung Bioepis has overturned a 2024 decision of the Korean Intellectual Property Trial and Appeal Board (IPTAB) which found that a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865) was valid.  The Korean patent has now been invalidated by the First Division of the Korean Patent Court.  An injunction granted in May 2025 based on the patent, preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept), is expected to be lifted.

This latest success for Samsung Bioepis follows a ruling in its favour by the Seoul Central District Court in February 2025, in a proceeding commenced by Regeneron in January 2023 seeking to prevent Samsung Bioepis from producing and selling Afilivu® in Korea.

Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024.  In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron.  This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

On 31 October 2025, Accord’s denosumab biosimilars, referencing Amgen’s Prolia® and Xgeva®, were approved by Australia’s Therapeutic Goods Administration (TGA) as follows:

• DENOLIA (450306) and DESKELTIA (450307) – denosumab 60mg/1mL solution for injection prefilled syringe with automatic needle guard;
• DOSTIVA (450305) and DEXEVA (450308) – denosumab 70mg/mL (120mg/1.7mL) solution for injection vial.

Accord is the fourth sponsor to obtain approval of denosumab biosimilars in Australia, following Sandoz’s Jubbonti® and Wyost® (August 2024), Celltrion’s Stoboclo® and Osenvelt® (April 2025), and Samsung Bioepis’ Ospomyv® and Xborso® (July 2025).

On 1 August 2025, Sandoz’s Jubbonti® and Wyost® became the first biosimilars to Amgen’s Prolia® and Xgeva® to be PBS-listed.  At its November 2025 meeting, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt®, for PBS-listing for all reference indications.

In April 2025, Amgen commenced Court proceedings in Australia seeking preliminary discovery of documents from Sandoz in relation to its denosumab biosimilars.  That proceeding concluded and Amgen commenced patent infringement litigation against Sandoz in the Federal Court of Australia in June 2025.

On 30 October 2025, Boan Biotech announced that it has completed enrolment for the clinical phase III study of its self-developed BA1104, biosimilar to BMS’ Opdivo® (nivolumab).  The study is being conducted in China and is aimed at comparing the efficacy, safety, and immunogenicity of BA1104 versus Opdivo® when combined with chemotherapy for treating patients with advanced or metastatic oesophageal squamous cell carcinoma.

While Boan Biotech’s trial is reported to be the first one for a nivolumab biosimilar in China, at least Amgen, Sandoz, Xbrane/Intas, Enzene and Reliance Life Sciences also have nivolumab biosimilars in development.  Zydus received regulatory approval for its nivolumab biosimilar from India’s CDSCO in July 2024 but has since faced injunction proceedings before the Delhi High Court.

Boan Biotech has received marketing approval in China for other biosimilars, including Boyoubei® (November 2022) and Boluojia® (May 2024), referencing Amgen’s Prolia® and Xgeva® (denosumab), respectively.  In July 2024, Boan announced that it had its application for biosimilar aflibercept, BA9101, accepted for evaluation in China.  Boan Biotech has also conducted trials on dulaglutide and bevacizumab biosimilars.

On 30 October 2025, New Zealand’s Medsafe approved Celltrion’s Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva (denosumab), respectively.  This makes Celltrion’s Stoboclo® and Osenvelt® the second pair of denosumab biosimilars approved in New Zealand, following Sandoz’s Jubbonti® and Wyost® in May 2025.

Celltrion’s denosumab biosimilars have been approved in various regions, including Korea (approved November 2024, launched March 2025), Europe (approved February 2025, not yet launched), the US (approved March 2025, launched July 2025), Australia (approved April 2025, not yet launched) and Canada (approved September 2025, not yet launched).

In May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab.  That litigation settled in January 2025, permitting the US launch of Celltrion’s denosumab biosimilars in July 2025.

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 October 2025, GlycoNex announced that the last patient has received the final dose in its phase 3 clinical study of SPD8, biosimilar to Amgen’s Prolia®/Xgeva® (denosumab).  The trial, which was commenced in late 2024, is assessing the efficacy, safety and immunogenicity of SPD8 in patients with osteoporosis.  GlycoNex plans to report top-line results from the study in the second quarter of 2026.

SPD8 was developed by GlycoNex in collaboration with Mitsubishi Gas Chemical.  In December 2024, GlycoNex entered into a licensing agreement with an undisclosed partner for SPD8, under which the licensee will be responsible for developing SPD8, securing regulatory approval, and commercialising the biosimilar in an undisclosed market.

Denosumab biosimilars have been approved around the world, including seven pairs of denosumab biosimilars approved in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025) and Richter/Hikma’s Enoby™ and Xtrenbo™ (approved September 2025, not yet launched).

The FDA has approved denosumab biosimilars Conexxence® and Bomyntra® (Fresenius Kabi) and Stoboclo® and Osenvelt® (Celltrion) as interchangeable with Amgen’s Prolia® and Xgeva®, respectively, for all approved indications, effective as of 29 October 2025.

Fresenius Kabi launched Conexxence® and Bomyntra® in early July 2025, following a global settlement agreement with Amgen, resulting in the dismissal of US BPCIA litigation commenced by Amgen in October 2024.  Amgen and Celltrion also settled their BPCIA litigation in January 2025, with Celltrion launching Stoboclo® and Osenvelt® in July 2025.

There are seven pairs of denosumab biosimilars approved in the US: Sandoz’s Jubbonti® and Wyost® (approved March 2024, launched June 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025, not yet launched), Celltrion’s Stoboclo® and Osenvelt® (approved March 2025, launched July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (approved March 2025, launched July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® (approved September 2025, not yet launched), Biocon’s Bosaya™ and Aukelso™ (approved September 2025, launched October 2025), and Richter/Hikma’s Enoby™and Xtrenbo™ (approved September 2025, not yet launched).

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 29 October 2025, the FDA announced proposed measures to make it faster and less costly to develop biosimilars, by simplifying biosimilarity studies, reducing unnecessary clinical trials and facilitating pharmacy level substitution.

In a new draft guidance, entitled “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies”, the FDA recommends that biosimilar sponsors consider a streamlined approach in which a clinical efficacy study (CES) may not be necessary to support a demonstration of biosimilarity.  The FDA suggests that this approach should be considered when:

• the reference product and biosimilar are manufactured from clonal cell lines, are highly purified and can be well characterised analytically;
• the relationship between quality attributes and clinical efficacy is generally understood for the reference product and can be evaluated by assays included in the comparative analytical assessment; and
• a human pharmacokinetic similarity study is feasible and clinically relevant.

In these circumstances, the adequacy of data from a comparative analytical assessment, pharmacokinetic similarity data, and immunogenicity assessment to support a demonstration of biosimilarity would be evaluated based on the totality of the evidence submitted in the biologics licence application (BLA).

The draft guidance is open for comment for 60 days and is expected to be published in its final form in 3 to 6 months.

In a separate initiative announced at the same time, the FDA also intends to make it easier for biosimilars to be developed as interchangeable with reference products by not requiring switching studies.

The FDA’s announcements follow similar initiatives in other regions, including the European Medicines Agency’s April 2025 reflection paper considering the possible waiver of comparative efficacy study requirements for biosimilars and India’s revised draft biosimilar guidelines in May 2025.

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).