On 11 September 2026, Celltrion’s Omlyclo®, biosimilar to Genentech/Novartis’ Xolair® (omalizumab), was approved in Australia in a 300 mg/2 mL solution for injection in pre-filled pen (PFP) and pre-filled syringe (PFS) forms.

The Australian approval follows launch of the 300 mg formulation of Omlyclo® in Europe (August 2026) and Korea (March 2026) and its approval in a number of other countries including the US (December 2025) and Canada (January 2026).

Omlyclo® is the only biosimilar omalizumab to have been approved in Australia, with the 75 mg/ 0.5 mL and 150 mg/1 mL PFS PBS-listed on 1 August 2025 and launched in Australia in September 2025, and the 75 mg/ 0.5 mL and 150 mg/1 mL PFP TGA-approved in August 2025 and recommended for PBS listing in April 2026.

Omalizumab biosimilars in development include Kashiv BioSciences/Alvotech’s ADL-018/AVT23, with an application for ADL-018 accepted for review by Health Canada in June 2026 and marketing applications for AVT23 accepted by the UK’s MHRA in March 2025 and the European Medicines Agency in October 2025.  Under an exclusive licensing agreement with Kashiv entered in October 2023, Alvotech holds the commercialisation rights to ADL-018/AVT23 in Canada, together with the European Economic Area, UK, Switzerland, Australia and New Zealand.  Kashiv has entered into agreements for commercialisation of ADL-018 with Cristália for LATAM (August 2025) and MS Pharma for MENA markets (August 2025).

Teva’s biosimilar omalizumab applications have been accepted for review in the US and EU (March 2026) and CuraTeQ announced Phase 3 study results for its biosimilar omalizumab, BP11, in April 2026.  Mabpharm claims to have had an omalizumab biosimilar (Aomaishu®) approved for marketing in China in May 2023.

On 11 September 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has accepted for review the new drug application (NDA) for HLX14 (120 mg/1.7 mL per vial), biosimilar to Amgen’s Xgeva® (denosumab).  This follows NMPA acceptance of Henlius’ NDA for a 60 mg/1.0 mL strength of HLX14 in December 2025.

HXL14 was approved in the EU and the US in September 2025, as Bildyos® (referencing Amgen’s Prolia®) and Bilprevda® (referencing Xgeva®), for all reference indications.  In March 2026, Henlius and its licensee, Organon, settled BPCIA litigation brought by Amgen in June 2025 in relation to Bildyos® and Bilprevda®.  HLX14 has also been approved in Canada, as Bildyos® and Tuzemty® (March 2026).

Shanghai Henlius entered into a licence agreement with Organon in June 2022 under which Organon has exclusive global commercialisation rights to HLX14 for all countries except China, Hong Kong, Macau and Taiwan.

There are a number of denosumab biosimilars approved in China, including Mabwell’s Mailishu® (approved March 2024, referencing Xgeva®) and Maiweijian® (approved May 2026, referencing Prolia®); Boan Biotech’s Boyoubei® (November 2022, referencing Prolia®) and Boluojia® (approved 2024, expanded May 2026, referencing Xgeva®); and Mabpharm’s Puboli® (approved June 2026, referencing Prolia®).

On 8 September 2026, Sandoz announced that it is aiming to establish a portfolio of more than 100 biosimilars by 2040 as part of its Bio100 plan to maximise value in the “golden decade” for biosimilars.  According to Sandoz, over the next 10 years, medicines worth more than USD 650 billion dollars are set to lose exclusivity, representing an unprecedented “golden decade” for patient access to more affordable medicines.

Sandoz currently markets 13 biosimilars and, in addition to substantially increasing that number over the next 14 years, the company plans to more than double its net sales from 2025 to 2035 and achieve a core EBITDA margin above 30%.

As part of Bio100, Sandoz has also announced its plans to build a new biosimilar drug manufacturing facility in Ljubljana, Slovenia.  The project will involve a US $300 million investment in disposable fed-batch technology to expand Sandoz’s in-house manufacturing capacity and strengthen end-to-end biosimilar development and manufacturing in Europe.

This manufacturing facility is additional to previously announced investments in Slovenia.  The facility is expected to become operational in 2029 and will be located next to Sandoz’s biosimilar development centre, which opened in June 2026.

On 8 September 2026, Biocon announced that, in partnership with Brazilian state-owned pharmaceutical laboratory, Bahiafarma, and Brazilian biotechnology company, Bionovis, it has entered a 10-year contract to supply Bmab 1500, biosimilar to Roche/Genentech’s Perjeta® (pertuzumab), under Brazil’s Productive Development Partnership (PDP) program.

Under the PDP, the partnership will have exclusive access to Brazil’s public healthcare market, which accounts for approximately 70% of the country’s total market.  Biocon will receive milestone payments and a share of revenues generated from the PDP opportunity over a 10-year period.

The deal had been foreshadowed at the India-Brazil Business Forum in February 2026, along with a similar partnership between Dr Reddy’s, Bionovis and Bahiafarma to manufacture biosimilar nivolumab in Brazil.

Biocon is currently being sued by Roche/Genentech in the US in relation to Bmab 1500, with BPCIA proceedings commenced in July 2026.  The litigation arises from Biocon’s submission of an abbreviated Biologics License Application (aBLA) for Bmab 1500, the date of filing of which is confidential.  Roche/Genentech allege Biocon infringes 28 US patents for inventions related to Perjeta® and various manufacturing methods for antibody production, covering pertuzumab as well as its use and manufacture.

Genentech also filed an ITC complaint in February 2026 against Biocon’s importation of Bmab 1500 into the US, alleging that, on 18 October 2025, Biocon imported more than 17,800 units of BMAB 1500 into the US from India before it received FDA approval

Shanghai Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).  BPCIA litigation filed by Roche/Genentech against Henlius/Organon was settled in January 2026 on confidential terms.

Approvals for pertuzumab biosimilars have been granted in India for Intas’ product (December 2024), Zydus’ Sigrima™ (June 2024) and Enzene’s Pertuza®/Perzea® (launched September 2025).  In Russia, Biocad’s Pertuvia™ (May 2025) and R-Pharm’s Persinthia™ (February 2026) are approved.  Litigation has been brought by Roche/Genentech against Biocad in Russia and Zydus in India.

In June 2026, EirGenix announced that it signed an agreement with an undisclosed company for the licensing and commercialisation of its pertuzumab biosimilar, EG1206A, in Japan.  This followed a 2025 global commercialisation deal with Sandoz for EG1206A, excluding Japan and a number of other countries in Asia.

On 4 September 2026, Business Standard reported that the Subject Expert Committee of India’s Central Drugs Standard Control Organisation (CDSCO) has given Roche a Phase 3 trial waiver for a high dose (920 mg) of Ocrevus® (ocrelizumab).  The waiver is conditional on Roche conducting Phase 4 (post-marketing) clinical trials in the Indian patient population.

CDSCO’s waiver of the Phase 3 trial requirements presents Roche with an expedited route to approval of the higher dose ocrelizumab product, which is indicated for treating relapsing and primary progressive forms of multiple sclerosis.

Roche’s Ocrevus® (300 mg) received a Phase 3 waiver in India in 2023 and was launched in that country in 2024.  The 920 mg formulation of Ocrevus® has been approved in 65 countries, including the EU (approved June 2024), UK (approved July 2024), US (approved September 2024), and Australia (approved March 2025).

Ocrelizumab biosimilars are in clinical trials sponsored by Amgen (Phase 3 underway, estimated primary completion in 2027), Biocad (Phase 3, enrolment commenced November 2025), Sandoz (Phase 3 trial underway, estimated primary completion in November 2026), Celltrion (Phase 3 IND for CT-P53 partially approved by the EMA in August 2023, currently recruiting, estimated primary completion dated in 2027) and R-Pharm (Phase 1 study commenced April 2025, primary completion in February 2026, with estimated completion in November 2027).  In January 2026, Samsung Bioepis announced that it had added an ocrelizumab biosimilar to its pipeline and, in July 2026, Teva and Polpharma entered into an exclusive licensing agreement for the commercialisation of Polpharma’s ocrelizumab biosimilar, PB018.

On 4 September 2026, Daily Pharm Korea reported that South Korean-based Shin Poong Pharm has received Korean regulatory approval for Denovon™, biosimilar to Amgen’s Prolia® (denosumab).  The biosimilar is anticipated to launch at the end of 2026 following reimbursement and pricing reviews.

Shin Poong has the exclusive Korean development and commercialisation rights to Denovon™ under a 2021 agreement with India’s Enzene Biosciences (an Alkem subsidiary).  Denovon™ is a 60 mg/1 mL prefilled syringe indicated for the treatment of osteoporosis in postmenopausal individuals, glucocorticoid-induced osteoporosis, and bone loss associated with certain prostate and breast cancers.

Denovan™ joins a number of other Prolia® biosimilars already approved or on the market in Korea, including Celltrion’s Stoboclo® and Osenvelt® (approved November 2024, launched by Daewoong in March 2025), Samsung Bioepis/Boryung’s Xbryk® (approved May 2025, launched 1 August 2025), Samsung Bioepis/Hanmi’s Obodence® (launched July 2025), and mAbxience/HK inno.N’s Izambia™ and Denbrayce™ (approved 5 February 2026).

On 3 September 2026, Samsung Bioepis announced that its Ustekinumab BS Intravenous Infusion [NIPRO] (SB17), biosimilar to Janssen’s Stelara®, was approved in Japan as induction therapy for moderate to severely active Crohn’s disease, where other treatments are ineffective.

The approval of the IV formulation comes 9 months after Samsung Bioepis’ subcutaneous ustekinumab (45 mg syringe) was approved in Japan (December 2025).  It was subsequently launched in May 2026.  Samsung Bioepis’ biosimilar ustekinumab is being commercialised in Japan by Nipro under the terms of a June 2025 agreement.

Samsung Bioepis’ IV formulation of ustekinumab closely follows Celltrion’s IV formulation of Steqeyma® (ustekinumab), which was approved in Japan in April 2026 and launched in August 2026. Steqeyma® (IV and SC) is indicated for psoriasis and psoriatic arthritis, with the IV formulation additionally approved for Crohn’s disease.

Other ustekinumab biosimilars launched in Japan include Alvotech/Fuji Pharma’s AVT04 (May 2024) and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, (May 2025).

On 3 September 2026, Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, announced that it has entered into a strategic partnership with China’s Qilu Pharmaceutical for the exclusive licensing and supply in the US of QL2107, biosimilar to MSD’s Keytruda® (pembrolizumab).

Under the agreement, Qilu is responsible for development, regulatory approval and supply of the product, while Cipla is responsible for US commercialisation.

Qilu commenced a Phase 3 study in January 2025 to compare the efficacy and safety of QL2107 vs Keytruda® in combination with chemotherapy in treating metastatic non-squamous non-small-cell lung cancer.  The study has an estimated primary completion date of December 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).

There are multiple pembrolizumab biosimilars in development with competition to be the first mover in major markets heating up.  Samsung Bioepis and Celltrion each applied for Korean approval of their pembrolizumab biosimilars in August 2026 (SB27 and CT-P51, respectively).  In June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Formycon announced successful Phase 1 results in February 2026, with its US commercialisation partner, Zydus, expressing optimism that it is well-placed to file the first BLA in the US for biosimilar pembrolizumab.  Formycon has also announced agreements for commercialisation of pembrolizumab biosimilar FYB206 with MS Pharma for the MENA region and Lotus for the Asia-Pacific.

Other companies with pembrolizumab biosimilars in clinical trials include Amgen, mAbxience, Sandoz, Shanghai Henlius, BioNTech, and Enzene.  Alvotech and Dr Reddy’s have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a Keytruda® biosimilar and Bio-Thera and Avalon are partnering on commercialisation of a pembrolizumab biosimilar (BAT3306) in Saudi Arabia/MENA.

On 2 September 2026, South Korean-headquartered Alteogen announced that it has entered into an option and licence agreement with Novartis for the development and commercialisation of subcutaneous (SC) formulations of Novartis products using Alteogen’s ALT-B4 drug delivery technology.  The Novartis products to be developed into SC formulations have not been disclosed.

ALT-B4 is a recombinant human hyaluronidase enzyme platform (berahyaluronidase alfa) which enables the conversion of biologics typically administered via intravenous infusion into more convenient and rapid SC formulations.

If Novartis’ multiple options under the agreement are exercised and all milestones are achieved, Alteogen is eligible to receive up to US$3.2 million, comprising option exercise fees, development and commercial milestone payments and royalties on net sales of products commercialised under the agreement.

The agreement with Novartis is the latest in a series of deals entered into by Alteogen in relation to the use of ALT-B4 in the development of subcutaneous formulations of biopharmaceutical and biosimilar products.  This includes a January 2026 agreement with Tesaro, a GSK subsidiary, for development of SC Jemperli® (dostarlimab); a 2019 exclusive licence, confirmed in June 2026, with Sanofi for development of a high dose SC formulation of Dupixent® (dupilumab), a November 2024 exclusive licence agreement with Daiichi Sankyo for SC Enhertu® (trastuzumab deruxtecan); a January 2023 agreement with Sandoz for an SC formulation of an undisclosed biosimilar; and the development of SC Keytruda® (pembrolizumab) with MSD, which has been approved including in the US as Keytruda Qlex™ (September 2025), EU (November 2025), Canada (February 2026) and Korea (May 2026).

Interest in subcutaneous formulations of antibody drug products is continuing to increase.  For example, on 21 August 2026, Huonslab announced that it secured Korean patent registration, and filed a PCT application, for its recombinant human-derived hyaluronidase-based formulation conversion platform technology (HyDIFFUZE™), applied to 11 antibody therapeutics, including pembrolizumab, bevacizumab and dupilumab.  A recent collaboration between Sandoz and Shanghai Henlius Biotech provides Sandoz with an option for a recombinant human hyaluronidase (HLXTE-Haase1001) to be used in the development of an SC biosimilar.  At the end of July 2026, it was announced that Celltrion is partnering with Korean-based G2GBIO to convert antibody drugs to SC formulations.  Meanwhile, MSD is currently engaged in litigation with Halozyme in the US and Europe in relation to Halozyme’s MDASE subcutaneous delivery technology and SC Keytruda® (pembrolizumab).

On 1 September 2026, Takeda commenced BPCIA proceedings against Alvotech in the US District Court for the District of New Jersey in relation to Alvotech’s AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab).  The litigation against Alvotech follows closely behind Takeda’s BPCIA proceedings against Polpharma filed in the same court on 26 August 2026 regarding Polpharma’s PB016 (vedolizumab).

In its complaint against Alvotech, Takeda alleges infringement of the same six US patents asserted against Polpharma relating to vedolizumab; its administration to treat inflammatory bowel disease, ulcerative colitis, and Crohn’s disease; and its formulation and method of manufacture (US patent numbers 9,663,579; 10,004,808; 12,053,526; 12,171,832; 12,544,445; and 12,622,969).

The proceedings arise from the FDA’s acceptance of Alvotech’s abbreviated Biologics License Application (aBLA) for AVT16, announced on 8 June 2026.  Takeda’s complaint discloses that Alvotech notified Takeda on 15 June 2026 of the FDA acceptance of the aBLA for AVT16 (injection for intravenous use in 300 mg single use vials) as an interchangeable biosimilar to Entyvio®.

Takeda is seeking remedies including preliminary and permanent injunctions to restrain the importation and sale of AVT16 in the US, and damages.

Under a strategic partnership entered in August 2020 and expanded in 2023, Alvotech granted to Teva the exclusive rights to commercialise AVT16 in the US.  According to the complaint filed with the US Court, in exchange for the licence, Teva agreed to pay Alvotech US$56 million, plus certain milestone payments.  Under a Product Supply Agreement, Teva also agreed to pay Alvotech’s cost of goods sold for each unit of AVT16 plus an additional percentage.

Alvotech also has a subcutaneous vedolizumab biosimilar under development (AVT80), with positive results from a PK study for the product announced in February 2026.  AVT80 is not named in the BCPIA litigation.

Other vedolizumab biosimilars are under development, including by Intas (Indian approval to conduct Phase I bioequivalence study of INTP53 in February 2025) and Samsung Bioepis (in early-stage development, global licence, development and commercialisation agreement (excluding certain Asian countries) entered with Sandoz in March 2026).

Fresenius Kabi, Advanz Pharma (Alvotech’s UK/EU commercialisation partner), Accord Healthcare (an Intas subsidiary) and Samsung Bioepis (together, Biosimilar Claimants) each commenced proceedings earlier this year in the High Court of England and Wales against Millennium Pharmaceuticals, a Takeda subsidiary. The Biosimilar Claimants are seeking to clear the way for the UK launch of their biosimilar vedolizumab products and have applied for the revocation of various Millenium patents and/or for non-infringement declarations or Arrow declarations.  The patents at issue concern dosing regimens in respect of vedolizumab (EP (UK) 3329965, 3311834 and pending patent applications EP4378484 and EP4438625)) and formulations of vedolizumab (EP (UK) 2704798 and 4403579).