Other Updates

On 9 November 2026, Sandoz announced that it has launched Owozy™, a generic version of Novo Nordisk’s Ozempic® (semaglutide), in Brazil.  This is the first semaglutide launch for Sandoz worldwide.

Owozy™ was developed by Malta-headquartered Adalvo and was approved in Brazil on 29 July 2026 for the treatment of type 2 diabetes.  According to Sandoz, Owozy™ is among the earliest new semaglutide treatment options available in Brazil, which has a GLP-1 market estimated to be worth USD 2.7 billion, with more than 16.5 million Brazilians living with diabetes.

The launch of Owozy™ in Brazil follows the approval of Sandoz’s generic semaglutide in Canada in September 2026, which is expected to launch by the end of 2026.

A number of generic semaglutide products have now been launched around the world.  In March 2026, Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark launched generic semaglutide products on the Indian market, following the expiry of Novo Nordisk’s core Indian patent for semaglutide.  Generic semaglutide products were also launched in Canada in May 2026 by Apotex and Dr Reddy’s.  Sun Pharma’s generic semaglutide injection was approved in South Africa (announced 15 July 2026), with launch following shortly thereafter.

Apotex received the first US FDA Tentative Approval for its generic semaglutide ANDA in April 2026, giving it an opportunity to be one of the first to launch generic Ozempic® in the US following expiry of Novo Nordisk’s exclusivity/patents.  Novo Nordisk has sued Apotex in the US in relation to generic Rybelsus®, Ozempic® and Wegovy®, alleging patent infringement, with the three cases being consolidated in June 2026.  Novo Nordisk also commenced Hatch Waxman litigation against Cipla in July 2026 in relation to generic semaglutide products.

On 6 November 2026, Bio-Thera Solutions announced that China’s National Medical Products Administration (NMPA) has approved BAT2506, biosimilar to Janssen’s Simponi® (golimumab), which will be marketed under the name 阿舒立® (Ashuli).  This is the first golimumab biosimilar to be approved in China.

BAT2506 was also the first (and to date remains the only) biosimilar golimumab approved in the US (in May 2026), where it will be commercialised by Accord BioPharma under the names Immgolis™ (referencing Simponi®) and Immgolis Intri™ (referencing Simponi® Aria).  On 30 September 2026, the US District Court for the District of Delaware granted Janssen a preliminary injunction preventing Accord/Bio-Thera from launching Immgolis™ and Immgolis Intri™ in the US during the term of the relevant patent(s).  The preliminary injunction was granted in the context of BPCIA proceedings commenced by Janssen against Accord and Bio-Thera on 3 March 2026, alleging that Immgolis™ and Immgolis Intri™ infringe 17 Janssen patents.  Accord and Bio-Thera have appealed the injunction decision (which is not yet publicly available), with a Notice of Appeal filed on 1 October 2026.

BAT2506 was approved in Europe, under the name Gotenfia®, in February 2026.  Gotenfia® is being commercialised in Europe by STADA under a May 2024 agreement.  It was the second golimumab biosimilar to be approved in Europe, following the approval of Alvotech/Advanz’s Gobivaz® (AVT05) in November 2025.

Bio-Thera has entered commercialisation agreements for BAT2506, including with Intas for Latin America (announced March 2026) and Canada ( announced October 2025), SteinCares for Latin America (announced March 2024) and Dr Reddy’s for South East Asia (announced March 2025).

On 5 November 2026, Celltrion announced that it launched three biosimilars in Brazil in October 2026: Qoyvolma®, biosimilar to Janssen’s Stelara® (ustekinumab), and Stoboclo® and Osenvelt®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively.

Qoyvolma® is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.  Stoboclo® and Osenvelt® are approved for the same indications as the reference medicine.

With this launch, Celltrion’s product range in Brazil has expanded to a total of 10 products, including infliximab, adalimumab, and omalizumab biosimilars.  Celltrion is planning to launch Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) and Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Brazil before the end of the year.

The launch of Celltrion’s ustekinumab biosimilar follows news that Biocon’s Yesintek® (ustekinumab) was permitted to enter the Brazilian market “with immediate effect” following a settlement agreement entered into by Biocon and Janssen in October 2026.  Bio-Thera and Biomm entered a licensing agreement for Bio-Thera’s BAT2206 (ustekinumab) in Brazil in June 2023.

There have been at least two reported denosumab biosimilar approvals in Brazil to date.  Sandoz’s Denbonli® (referencing Amgen’s Prolia®) and Wyost® (referencing Amgen’s Xgeva®) received approval in September 2025.  Abbott/mAbxience received approval for two unnamed denosumab biosimilars in June 2026.  There are denosumab biosimilars under development for the Brazilian market by at least Mabwell/Cristália (strategic agreement entered August 2024) and Boan Biotech and an unnamed strategic partner (strategic agreement entered November 2024).

On 3 November 2026, Samsung Bioepis and Teva announced they have entered a licence and commercialisation agreement for Eticovo®, biosimilar to Immunex/Amgen’s Enbrel® (etanercept), and Renflexis®, biosimilar to Janssen’s Remicade® (infliximab).  According to a regulatory filing by Samsung Bioepis, the deal is worth up to 563.2 billion won (US$420 million).

Under the terms of the agreement, Teva will obtain US commercialisation rights to Eticovo® at closing (anticipated by the end of 2026), while the US commercialisation rights to biosimilar infliximab will transfer to Teva in Q3/2027.  Samsung Bioepis will remain responsible for regulatory oversight and manufacturing of both products.

Subject to certain conditions, Teva will pay Samsung Bioepis an upfront payment over the next 3 years.  Samsung Bioepis may also be eligible for additional launch and sales milestone payments.  Teva and Samsung Bioepis will share the profits from the commercialisation of the biosimilars.

Samsung Bioepis’ Eticovo® was approved by the FDA in April 2019.  Samsung Bioepis is prevented from launching Eticovo® in the US until 2029 by a permanent injunction granted by the US District Court for the District of New Jersey in November 2021.  Samsung Bioepis’ Renflexis® (infliximab-abda) was approved in the US in April 2017.

Teva and Samsung Bioepis first entered into a strategic partnership in January 2025 for the US-commercialisation of Samsung Bioepis’ Epysqli® (eculizumab-aagh), biosimilar to Alexion’s Soliris®.  In July 2026, that agreement was expanded to include the commercialisation of Samsung Bioepis’ Opuviz® (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, in Canada.

On 1 October 2026, Samsung Bioepis and Teva announced a global collaboration and licence agreement for the US, Canada and Europe, to expand their existing partnership for up to six additional biosimilars, including SB44, biosimilar to Novartis’ Ilaris® (canakinumab), and SB41, biosimilar to AstraZeneca’s Fasenra® (benralizumab), plus four other undisclosed early-stage biosimilars.

On 2 November 2026, Fresenius announced that it has entered an exclusive development agreement with WuXi Biologics, a large-scale biologics developer and manufacturer of monoclonal and bispecific antibodies and antibody-drug conjugates.  According to Fresenius, this is the largest development agreement announced in the biosimilars industry to date.

The agreement provides Fresenius with exclusive access to up to 37 identified biosimilar candidates over the next decade.  If Fresenius exercises all of its options, its portfolio of marketed and pipeline molecules would grow from 29 to as many as 66.

The products developed under the agreement are expected to span 13 therapeutic areas, including neurology, nephrology, cardiopulmonary, oncology, immunology, and gastroenterology, and will include monoclonal and bispecific antibodies, antibody-drug conjugates and fusion proteins.  Initial development is expected to focus on polatuzumab vedotin, biosimilar to Genentech’s Polivy®, an antibody-drug conjugate for the treatment of diffuse large B-cell lymphoma, and teprotumumab, biosimilar to Amgen’s Tepezza®, a monoclonal antibody for the treatment of Thyroid Eye Disease.

Under the terms of the agreement, WuXi will be paid on a fee-for-service basis for each candidate Fresenius selects for development.  Fresenius retains exclusive global commercialisation rights, including marketing authorisations, and the full economics of any commercialised products.

The agreement builds on Fresenius’ full acquisition of mAbxience, completion of which was announced on 1 October 2026.

On 2 November 2026, South Korea’s The Financial News, reported that Sam Chun Dang (SCD) has entered into an exclusive sales and supply agreement in Japan with Daiichi Sankyo Espha (DSE) for SCD411, biosimilar to Regeneron/Bayer’s Eylea (aflibercept), 2 mg.  In doing so, SCD has terminated an agreement with Senju Pharmaceutical, its existing partner for the aflibercept biosimilar in Japan.

Under the new agreement with DSE, SCD now holds the marketing authorisation in its own name through Japan’s special approval system for foreign manufacturers.  This is a change from the previous arrangement in which Senju Pharmaceutical held the marketing authorisation.  DSE has responsibility under the agreement for local sales and promotion of SCD411 2 mg pre-filled syringes and vials.

In August 2026, SCD signed a settlement agreement with Regeneron and Bayer to resolve all patent disputes in Europe, Korea and Japan involving SCD411.  The financial terms of the settlement have not been disclosed.

SCD411 was approved in vial and pre-filled syringe forms in Japan and Korea in September 2025.  It has not yet been launched in Japan but was launched in Korea as Vgenfli™ in December 2025.

In Europe, SCD411 was approved as Vgenfli™ in August 2025, with Zaklady Farmaceutyczne Polpharma as the marketing authorisation holder.  SCD has announced licence agreements with an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).

SCD and its US exclusive licensee, Fresenius Kabi, settled US aflibercept litigation with Regeneron/Bayer in February 2026.  The settlement permits Fresenius to launch SCD411/Vygenfree™ in the US at an undisclosed time.  The FDA accepted SCD’s application for SCD411 for review in December 2025 but the biosimilar has not yet been FDA-approved.

Regeneron, Bayer and Apotex, SCD’s commercialisation partner under an August 2023 agreement, settled their Canadian aflibercept litigation in June 2024.  Health Canada approved SCD411 as Aflivu™ in June 2025 and it was launched in July 2025.

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 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.