On 21 September 2026, Sandoz Group AG joined the Swiss Market Index (SMI), Switzerland’s leading blue-chip equity index.  The milestone was foreshadowed in an announcement by Sandoz on 9 July 2026 and comes less than three years after Sandoz became an independent publicly listed company.

The SMI comprises the 20 largest and most liquid stocks listed on the SIX Swiss Exchange and is widely regarded as the benchmark index for Swiss equities.  Other pharmaceutical companies on the SMI are Novartis AG and Roche Holding AG.  Dermatology focussed company, Galderma, also began trading on the SMI on 21 September 2026.

Sandoz recently 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.

On 18 September 2026, Sandoz announced that Health Canada has approved Sandoz® Semaglutide, a generic version of Novo Nordisk’s Ozempic® (semaglutide).  This is in line with Sandoz’s expectations for a 2026 launch of the product.

Sandoz® Semaglutide is approved as a subcutaneous injection in a pre-filled pen (2 mg/pen; 1.34mg/mL; and 4 mg/pen; 1.34 mg/mL).  It is indicated for once-weekly treatment of adult patients with type-2 diabetes mellitus to improve glycaemic control.

Generic semaglutide products have previously been approved in Canada for the treatment of type 2 diabetes.  Apotex’s Apo-Semaglutide Injection™ was approved on 1 May 2026 and launched 14 May 2026, while Dr Reddy’s Laboratories’ generic semaglutide injection was approved on 29 April 2026 and also launched on 14 May 2026.

On 29 June 2026, Apotex’s Sevmia™, generic version of Novo Nordisk’s Wegovy®, became the first approved generic semaglutide product in Canada indicated for weight loss.

Generic semaglutide products have also launched in India (from March 2026) and have been approved in South America (July 2026).  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 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September 2026 meeting, including positive opinions for the following two biosimilars.

1. Alvotech/Advanz’s Adcomfo® (omalizumab)

Alvotech/Advanz Pharma’s Adcomfo® (AVT23/ADL-018), biosimilar to Genentech/Novartis’ Xolair® (omalizumab), is recommended for approval in 75 mg, 150 mg and 300 mg solution for injection in a pre-filled syringe (PFS) or pre-filled pen (PFP).  The CHMP opinion follows EMA acceptance of the marketing authorisation application for AVT23 in October 2025.

Adcomfo® was developed by Alvotech in collaboration with Kashiv Biosciences and is the subject of an October 2023 licensing agreement under which Advanz Pharma has exclusive commercialisation rights for the European Economic Area (European Union, Norway, Iceland and Lichtenstein), the UK, Switzerland, Canada, Australia and New Zealand.  A marketing application for AVT23 was accepted by the UK’s MHRA in March 2025.

Celltrion’s Omlyclo® was the first (and to date remains the only) omalizumab biosimilar to be approved in the EU, with Celltrion receiving EU market authorisation for its 75 mg/0.5 mL and 150 mg/1 mL PFS formulations in May 2024, and approval for the 300 mg formulation in November 2025.  Celltrion commenced its European rollout of Omlyclo® (75 mg/0.5 mL and 150 mg/1 mL) in Norway in September 2025, and completed the launch of those formulations in major European countries including Germany, Spain, the UK and France in November 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.

2. Biocon’s Pebrilzo® (pertuzumab)

The CHMP has also recommended Biocon’s Pebrilzo® (Bmab 1500), biosimilar to Roche/Genentech’s Perjeta® (pertuzumab), for the treatment of HER-2 positive breast cancer (420 mg concentrate for solution for infusion).

Pebrilzo® follows Shanghai Henlius/Organon’s pertuzumab biosimilar, Poherdy®, which was approved in Europe in April 2026 (and in the US (November 2025) and China (as Hanbeiyou®, May 2026)).

Biocon is currently being sued by Roche/Genentech in the US in relation to Bmab 1500, with BPCIA proceedings commenced in July 2026.  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.

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 18 September 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its September 2026 meeting, including positive opinions for new biopharmaceuticals and indication extensions for already approved medicines.

The new medicines recommended for approval by the CHMP include:

• AstraZeneca/Alexion’s Klygefa® (gefurulimab) for the treatment of adult patients with generalised myasthenia gravis. According to AstraZeneca, if approved, Klygefa will be the first and only dual-binding nanobody C5 inhibitor for this patient population; and
• Novo’s Frehemgo® (denecimig). Frehemgo is a next-generation factor VIIIa mimetic bispecific antibody for the prophylaxis of bleeding episodes in patients with haemophilia A.  Novo expects to launch Frehemgo® in the first European countries in Q4/2026 and more widely across the EU starting in early 2027.

The CHMP’s September 2026 recommendations for extended indications include:

• Novartis’ Cosentyx® (secukinumab) for the treatment of polymyalgia rheumatica in adults who have had an inadequate response to glucocorticoids or who experience a relapse during glucocorticoid taper;
• AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan), as monotherapy for the adjuvant treatment of adult patients with resected HER2-positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2-targeted treatment;
• MSD’s Keytruda® (pembrolizumab) in combination with Astellas’ Padcev® (enfortumab vedotin), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for the treatment of adults with resectable muscle invasive bladder cancer (MIBC), whether or not the patient is ineligible for cisplatin-containing chemotherapy;
• Roche’s Ocrevus® (ocrelizumab) for the treatment of paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS); and
• Johnson & Johnson’s Tecvayli® (teclistamab), for treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least one prior therapy,

The CHMP also recommended approval of two biosimilars at its September 2026 meeting, as reported separately here.

On 18 September 2026, Sandoz and mAbxience announced they have entered a licensing, development, manufacturing and commercialisation agreement in relation to a biosimilar to Roche/Chugai’s Hemlibra® (emicizumab).  The biosimilar is in early stage development and will be the first haemophilia medicine in the Sandoz biosimilar pipeline.

While the financial terms of the agreement are confidential, the agreement provides Sandoz with the exclusive global commercialisation rights for the emicizumab biosimilar, excluding Argentina, Uruguay and Paraguay.  mAbxience has responsibility for biosimilar development and manufacturing.

Sandoz’s collaboration with mAbxience follows its August 2026 agreement with Shanghai Henlius for up to 10 biosimilars, including cetuximab (HLX05-N), evolocumab (HLX16) and belimumab, and its March 2026 agreement with Samsung Bioepis for up to 5 biosimilars, including vedolizumab (SB36). These agreements represent steps in Sandoz’s strategy to expand its biosimilar portfolio to 100+ by 2040 and to maximise value in the “golden decade” for biosimilars, with medicines worth more than USD 650 billion set to lose exclusivity.

Biosimilar emicizumab is being developed by Alvotech, which announced a licensing and commercialisation agreement with Lotus Pharmaceutical in August 2026 including for AVT87 (emicizumab) in the US and eight Asian markets.  CSPC Pharmaceutical Group, announced in March 2026 that China’s National Medical Products Administration approved clinical trials for its biosimilar emicizumab (SYS6053).  Prestige BioPharma has a preclinical emicizumab biosimilar in its pipeline.

On 17 September 2026, India-based contract development and manufacturing organisation (CDMO) Shilpa Biologicals announced that it has signed an exclusive licence and commercialisation agreement with Saudi Arabia-based SPIMACO Bio for a “portfolio of PD-1 inhibitor biosimilars” across the Middle East and North Africa (MENA).  While the press release does not name the specific products covered by the agreement, the only PD-1 inhibitors that Shilpa currently identifies in its pipeline are biosimilars to MSD’s Keytruda® (pembrolizumab) and BMS’ Opdivo® (nivolumab).

Under the terms of the agreement, Shilpa has responsibility for the exclusive development and manufacturing of the biosimilars, together with a phased technology transfer to establish local biosimilar manufacturing in Saudi Arabia, while SPIMACO is responsible for regulatory filings, market access, and commercialisation across the region.

The agreement with SPIMACO follows a June 2026 agreement between Shilpa and Orion Pharma in relation to the European commercialisation of Shilpa’s intravenous nivolumab biosimilar.

Competition is heating up in relation to the first PD-1 inhibitor biosimilar to be approved in major markets.  Amgen has become 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.  Meanwhile, two biosimilars have been launched in India (Zydus’ Tishtha™ (January 2026) and Dr Reddy’s Nivorz® (September 2026)), and 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.

Applications for approval of pembrolizumab biosimilars were filed in Korea by Samsung Bioepis (SB27) and Celltrion (CT-P51) in August 2026.  Two months earlier, in June 2026, Samsung Bioepis claimed to be the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later this year.  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.  Pembrolizumab biosimilars are also in clinical trials including by mAbxience, Sandoz, Bio-Thera, Shanghai Henlius, BioNTech, Qilu Pharmaceutical and Enzene.

Keytruda® 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).

On 16 September 2026, Daiichi Sankyo announced that Japan’s Ministry of Health, Labour and Welfare has approved Enhertu® (trastuzumab deruxtecan) and Datroway® (datopotamab deruxtecan) for two new breast cancer indications.  Enhertu®, in combination with pertuzumab (Roche’s Perjeta®) was approved for the treatment of adults with HER2 positive unresectable or recurrent breast cancer, while Datroway® was approved for adults with hormone receptor negative and HER2 negative unresectable or recurrent breast cancer.

The same new indication for Enhertu® was recently approved in Europe and was approved by the FDA in December 2025.  These are the first new regimens in more than a decade to be approved in for the first line treatment of HER2 positive breast cancer.

Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialise Enhertu® in March 2019 and Datroway® in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each product.  Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu® and Datroway®.

Biosimilars of Enhertu® are under development.  Samsung Bioepis has a trastuzumab deruxtecan biosimilar in its pipeline, while Shanghai Henlius and Organon are leading the pertuzumab biosimilar race in major markets, with approvals of Poherdy® (pertuzumab) secured in the US (November 2025), EU (April 2026), and China (as Hanbeiyou®, May 2026).  Roche/Genentech are currently suing Biocon in the US in relation to biosimilar pertuzumab (Bmab 1500).

On 16 September 2026, MSD’s subcutaneous pembrolizumab was approved in Japan under the name Keyject™.  Keyject™ (pembrolizumab and berahyaluronidase alfa) is approved for the same indications as Keytruda® (IV formulation) and is the first subcutaneous immune checkpoint inhibitor approved in Japan.

MSD’s subcutaneous pembrolizumab has been approved in a number of countries, including in the US as Keytruda Qlex™ (September 2025), and in the EU (November 2025), Canada (February 2026), Korea (May 2026) and Australia (July 2026), as Keytruda SC™.

MSD is currently engaged in disputes with Halozyme in relation to Keytruda SC™, with Halozyme alleging that MSD is infringing various patents to Halozyme’s MDASE™ subcutaneous delivery technology, including:

• in April 2024, Halozyme sued MSD in the US, alleging that MSD’s subcutaneous Keytruda® (Keytruda Qlex®) infringes 15 patents.  MSD has successfully invalidated claims of a number of Halozyme’s US patents before the Patent Trial and Appeal Board;
• in December 2025, the Munich Regional Court granted a preliminary injunction (PI) to Halozyme, preventing MSD from distributing and offering for sale in Germany Keytruda SC™; and
• in July 2026, the District Court of The Hague published a judgment dismissing Halozyme’s application for a PI to prevent MSD from marketing Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) in Denmark and Sweden pending the outcome of substantive proceedings.

While there are no reports of biosimilar subcutaneous pembrolizumab development to date, there are multiple pembrolizumab biosimilars approved or in development.  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.  Amgen also confirmed on 15 September 2026 that its Keytruda® biosimilar has successfully completed clinical trials with an FDA submission likely later this year.  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.

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 16 September 2026, Teva filed an application seeking declaratory judgment of non-infringement and invalidity in relation to 14 Janssen patents asserted against Alvotech in BPCIA litigation commenced on 19 June 2026 in the US District Court for the Eastern District of Virginia.  As previously reported (here), in the proceedings, Janssen is alleging that Alvotech’s AVT05, biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab), infringes those 14 patents.

Janssen is seeking preliminary and permanent injunctions against Alvotech (together with “any other persons who are in active concert or participation with them”) to prevent the manufacture and sale of AVT05, and its importation into, the US.

On the basis that Teva has the exclusive commercialisation rights for Alvotech’s biosimilar golimumab products in the US under an August 2020 strategic partnership, Teva filed a motion to intervene in the BPCIA litigation on 28 August 2026.  That motion was granted by Court orders on 9 September 2026.

In its application for a declaration of non-infringement, Teva alleges that Janssen’s processes for manufacturing biosimilar golimumab, including steps in the cell culture process and the glycan content of the recombinant protein preparation, do not infringe the claims of any of the 14 patents.  Teva also claims that each of the patents is invalid, for example, for lack of novelty or obviousness.

The litigation against Alvotech is the second BPCIA proceeding regarding golimumab commenced by Janssen, following a complaint filed against Bio-Thera Solutions and Accord BioPharma in March 2026.  That complaint alleges that Bio-Thera/Accord’s golimumab biosimilars (Immgolis™ and Immgolis Intri™ (BAT2506)), the first and only golimumab biosimilars to have been FDA-approved (May 2026), infringe 17 Janssen patents.  A preliminary injunction hearing was conducted on 1 September 2026.

Accord Biopharma, Intas and Bio-Thera have filed petitions for inter partes review (IPR) of 4 Janssen method of treatment patents related to golimumab (IPR2026-00256, IPR2026-00257, IPR2026-00258, IPR2026-00259).  Those IPRs were instituted by the Patent Trial and Appeal Board on 9 September 2026.

On 15 September 2026, The Economic Times reported that Dr Reddy’s has launched Nivorz™, biosimilar to BMS’ Opdivo® (nivolumab), in India.  Nivorz™ will be available in single-dose vial presentations (40 mg, 100 mg and 240 mg) and will be manufactured at Dr Reddy’s biologics facility in Bachupally, Hyderabad.

Nivorz™ is the second nivolumab biosimilar to be launched in India following Zydus’ Tishtha®, which was the first nivolumab biosimilar to be launched in the world when it became available in India in January 2026 (approved July 2024).

Multiple nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, and Boan Biotech’s BA1104.