On 30 October 2026, Samsung Bioepis announced that it has applied to the FDA for marketing authorisation of SB27, biosimilar to MSD’s Keytruda® (pembrolizumab), across 18 cancer indications.

This is the second reported US filing for a pembrolizumab biosimilar following Formycon/Zydus’ Biologics Licence Application for FYB206.  Formycon/Zydus announced on 13 October 2026 that the FDA had accepted for review their FYB206 BLA.

In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  In comparison, Formycon is relying on a streamlined clinical trial pathway (without a comparative Phase 3 efficacy trial) to accelerate and support the approval of its pembrolizumab biosimilar FYB206.

Applications for approval of pembrolizumab biosimilars were filed in Korea by Samsung Bioepis (SB27) and Celltrion (CT-P51) in August 2026.  Amgen confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later in 2026.

Pembrolizumab biosimilars have reportedly been launched in Paraguay (by Bioeticos in August 2025) and approved in Vietnam (by Biocad in November 2025) and Jordan (by Sana Pharma in February 2026).  Pembrolizumab biosimilars are also in clinical trials including by mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.

On 30 October 2026, China-headquartered Boan Biotech announced that it has licensed BA6101 (denosumab), biosimilar to Amgen’s Prolia® (marketed in Japan as Pralia®), to an undisclosed partner for Japan.

Under the agreement Boan Biotech’s partner has exclusive commercialisation rights to BA6101 in Japan and is responsible for regulatory submission, market access, promotion and sales of the biosimilar in the Japanese market.  Boan Biotech will receive an upfront payment, milestone payments and royalties on sales.

BA6101 (marketed as Boyoubei® in China) was approved in China in November 2022 (with BA1102 (Boluojia®), referencing Amgen’s Xgeva® (denosumab) first approved in China in 2024) and in Bolivia in January 2026.  In November 2025, Boan’s MAAs for BA6101 and BA1102 were accepted for review by the UK Medicines and Healthcare products Regulatory Agency (MHRA).  Boan Biotech submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg) and BA1102 (denosumab 120 mg), biosimilars to Amgen’s Prolia® and Xgeva® respectively, in May 2026.  Boan Biotech is expecting approvals in the UK and US within the next year.

Boan Biotech also intends to seek marketing authorisation for BA6101 in other countries and regions and has established a network of partners to commercialise the drug, including in the US, Southeast Asia, and Latin America.

There is one approved denosumab biosimilar in Japan to date, Alvotech/Fuji Pharma’s AVT03 (DENOSUMAB BS 120 mg/1.4 mL in a vial for subcutaneous injection; September 2025), biosimilar to Daiichi Sankyo’s Ranmark® (marketed in other countries as Amgen’s Xgeva®).  On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating therapeutic equivalence to Amgen’s Prolia®.  SPD8 was co-developed by GlycoNex with Mitsubishi Gas Chemical.

On 27 October 2026, STADA and Xbrane Biopharma (Xbrane) announced that the FDA has approved Lucamzi™ (ranibizumab-blrz), biosimilar to Genentech’s Lucentis®, for the treatment of neovascular (wet) age-related macular degeneration and other serious eye conditions.

The approval follows STADA’s and Xbrane’s announcement on 3 June 2026 that the FDA had accepted its biosimilar ranibizumab BLA, which was given a Biosimilar User Fee Act (BsUFA) action date of 29 October 2026.  The ranibizumab biosimilar was co-developed by Xbrane and STADA under a 2018 agreement, and is the subject of an exclusive licensing agreement with Valorum Biologics, which will be responsible for commercialising Lucamzi™ in the US.

Xbrane resubmitted its BLA in April 2026 following an FDA Complete Response Letter (CRL) received in October 2025.  This was the second CRL issued in relation to Xbrane’s ranibizumab BLA following 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.

A number of other ranibizumab biosimilars are approved in the US including Samsung Bioepis’ Byooviz® (September 2021, relaunched July 2026), Sandoz’s Cimerli® (August 2022, rights acquired by Sandoz from Coherus in March 2024), Formycon’s Nufymco® (December 2025) and Lupin’s Ranluspec® (June 2026).

Xbrane’s ranibizumab biosimilar has been approved in the EU and UK since November 2022, under the name Ximluci®, and was launched in the EU in April 2023.

On 26 October 2026, Biocon announced that it has signed a licence agreement with Janssen clearing the way for the commercialization of Yesintek™, biosimilar to Janssen’s Stelara® (ustekinumab), in Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea and Kazakhstan.  Under the agreement, Biocon is permitted to commercialise Yesintek™ in the relevant countries “with immediate effect”.

Biocon first launched Yesintek™ in the US in February 2025 (in PFS and vial presentations), following Yesintek™’s original FDA approval in November 2024.  The timing of Biocon’s US launch was governed by a US settlement and licence agreement with Janssen (entered in February 2024), including to resolve an Inter Partes Review Petition.

In August 2024, Biocon announced that it had signed a patent settlement and licence agreement with Janssen for Canada, Japan, Europe and the UK.  Yesintek™ was launched in Canada in October 2025 and was approved in Europe in February 2025 and in Japan in December 2024 (announced January 2025).

Yesintek™ was approved in Australia in April 2026 and was recommended for listing on the Pharmaceutical Benefits Scheme at the July 2026 meeting of the Pharmaceutical Benefits Advisory Committee.  It is to be supplied in Australia by Biocon’s local partner Generic Health.

On 26 October 2026, Bio-Thera Solutions announced that it has received marketing authorisation from China’s National Medical Products Administration (NMPA) for BAT2306 (marketed as Youzhuomei™), biosimilar to Novartis’ Cosentyx® (secukinumab).  BAT2306/Youzhuomei™ is the first biosimilar secukinumab approved in China.  According to Bio-Thera, it is also the first biosimilar secukinumab approved by any major regulatory agency in the world.

BAT2306/Youzhuomei™ is approved for psoriasis, ankylosing spondylitis and psoriatic arthritis.  Cosentyx® is approved in China for the treatment of plaque psoriasis in patients aged 6 years and older; and for psoriatic arthritis, ankylosing spondylitis, hidradenitis suppurativa and non-radiographic axial spondyloarthritis in adults.

Bio-Thera completed a phase 3 clinical trial of BAT2306 in plaque psoriasis in 2024, and a phase 1 trial in 2023.  It has signed commercialisation agreements for BAT2306 with multiple partners, including Pharmapark in Russia (August 2024), Jamjoon Pharmaceuticals in Middle East and North Africa (September 2025), and Dr Reddy’s in Southeast Asia (November 2025).

Secukinumab biosimilars are also under development by Celltrion (phase 1 clinical trial completed; global phase 3 trial for CT-P55 in plaque psoriasis approved by the FDA in August 2024), Taizhou Mabtech Pharmaceutical (phase 1 trial of CMAB015 completed in 2023) and Livzon Pharmaceutical Group (phase 3 clinical trial of LZM012 in plaque psoriasis currently recruiting).  In June 2026, CSPC Pharmaceutical announced that China’s NMPA had accepted for review a marketing authorisation application for its Secukinumab Injection.

On 26 October 2026, Celltrion announced that its US subsidiary has signed an exclusive supply agreement with a major US healthcare company for its pre-filled syringe (PFS) formulation of Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), and its intravenous and subcutaneous formulations of Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab).  The unidentified US healthcare company owns various large hospitals, insurance companies and pharmacy benefit managers (PBMs) across the US.

Under the agreement, Omlyclo® and Avtozma® will be listed as the sole preferred products on the insurers’ formularies and supplied to affiliated medical institutions.  Insured patients who receive a prescription of either product will be able to receive treatment under their insurance coverage.  Product supply and insurance coverage began in October 2026.

Celltrion’s Omlyclo® was launched in the US in October 2026, following approval in March 2025 (75 mg/0.5ml and 150 mg/ml PFS forms) and December 2025 (300mg formulation).  Leveraging its first-mover advantage as the first omalizumab biosimilar launched in the US, Celltrion is expanding its supply channels for Omlyclo®.  In October 2026, Celltrion signed a separate supply contract for Omlyclo® with a major global US distributor.  Additionally, Celltrion is conducting formulary listing negotiations with multiple PBMs, with the contracts expected to finalise within Q4 of 2026.

Both intravenous and subcutaneous formulations of Avtozma® were first approved in the US in January 2025, with the IV formulation launched in October 2025.  In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.

On 21 October 2026, German-headquartered Formycon announced that it has entered into a collaboration with South American company, Biocelys, to develop an undisclosed biosimilar, FYB286.  Formycon refers to the biosimilar as a “niche buster”, a drug for a rare condition with global annual sales in the low- to mid-single-digit billion-dollar range.

The collaboration is aimed at combining Formycon’s experience in biosimilar development with Biocelys’ state-of-the-art manufacturing infrastructure.  Formycon expects demand for FYB286 to increase substantially, particularly in emerging markets, presenting an attractive market opportunity.

Biocelys is indirectly controlled by ATHOS KG, which is Formycon’s largest shareholder.  The project is being financed upfront by Santo Biosimilar GmbH, an affiliated company of ATHOS.  Under the agreement with Santo, Formycon will receive arm’s-length compensation for its development services and will participate in future revenues of Santo with a low double-digit percentage share.  The co-operation agreement between Formycon and Biocelys covers joint development, manufacture, regulatory approval and supply management of FYB286.

On 29 September 2026, the Subject Expert Committee (SEC) under India’s Central Drugs Standard Control Organisation (CDSCO) recommended the approval of Alvotech/Dr Reddy’s Laboratories’ 120 mg/1 mL denosumab, biosimilar to Amgen’s Xgeva®, in a pre-filled syringe (PFS) with an automatic needle guard.  This new presentation expands Alvotech/Dr Reddy’s denosumab portfolio in India, following the approval of its denosumab vial presentation (120 mg/1.7 mL solution for injection) in August 2017.

The approval is conditional on Dr Reddy’s Laboratories submitting an active post-marketing surveillance study protocol for the approved indications within three months and conducting the study in India and adding product label warnings for patients with phenylketonuria regarding the presence of phenylalanine in the product.

Dr Reddy’s and Alvotech entered into a licence and supply agreement in May 2024 for the commercialisation of AVT03 (denosumab), under which Alvotech develops and manufactures the product and Dr Reddy’s commercialises it exclusively in the US, and semi-exclusively in the EU and UK.

Alvotech also has semi-exclusive commercialisation agreements for European markets with STADA (June 2024) in relation to AVT03.  STADA will market AVT03 as Kefdensis® (referencing Amgen’s Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).

On 20 October 2026, Samsung Bioepis announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has signed an exclusive partnership agreement to supply SB12, biosimilar to Alexion’s Soliris® (eculizumab), to Brazil’s universal public health system.

The agreement is formed under Brazil’s strategic Productive Development Partnership (PDP) framework.  Under the PDP program, Samsung Bioepis will have exclusive access to Brazil’s public healthcare market to supply eculizumab over a 10-year period form 2027.  During this period, Samsung Bioepis will also transfer technology to its local partners, enabling manufacturing in Brazil.

SB12 was approved in Brazil in December 2024 for the treatment of adults and children with PNH and atypical haemolytic uremic syndrome (aHUS).  It was the second eculizumab biosimilar launched in the US (where it is marketed by Teva as Epysqli®) in April 2025, following the launch of Amgen’s Bkemv® in March 2025.  Epysqli® launched in Germany, Italy and Spain in October 2023 and in Korea in April 2024.

Since 2019, Samsung Bioepis has supplied more than 6 million units of its etanercept and trastuzumab biosimilars in Brazil through the PDP program.  In September 2026, Biocon entered into a supply deal with the Brazilian government to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertuzumab) under the PDP program.

On 18 October 2026, the Economic Times reported that Lupin has received marketing approval from India’s Central Drugs Standard Control Organisation (CDSCO) for its nivolumab biosimilar, referencing BMS’ Opdivo®.  No launch plans have been announced to date.

The biosimilar is approved for the same indications as the reference medicine, with the approval subject to Lupin conducting a Phase IV (post-marketing) study in India.  The approval was granted based on positive results from a local Phase III clinical trial, demonstrating comparable pharmacokinetics, efficacy and immunogenicity of the biosimilar with BMS’ Opdivo®.

Lupin will manufacture the biosimilar in partnership with Virchow Biotech, a contract development and manufacturing organisation (CDMO) headquartered in India.

Zydus’ Tishtha® was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024).  This was followed by the Indian launch of the Dr Reddy’s nivolumab biosimilar Nivorz™ in September 2026.

Amgen is the first known company to file an application with the FDA for a biosimilar to BMS’ Opdivo®, having disclosed the US filing of its aBLA for ABP 206 (nivolumab) on 15 September 2026.  Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.