On 24 September 2026, Nanexa announced that it has entered into an exclusive global licence and collaboration agreement with Novo Nordisk for the development of long-acting injectable formulations of Novo Nordisk’s products using Nanexa’s PharmaShell® drug delivery platform.  The Novo products to be developed have not been disclosed but will target type 2 diabetes, obesity and other cardiometabolic diseases.

Under the agreement, Denmark-based Novo will receive a global licence to use Sweden-based Nanexa’s PharmaShell® technology platform for up to five development programs.  The long-acting injectable formulations will be developed with monthly and quarterly frequency administration targets.

Nanexa will receive EUR615 million for upfront, development and regulatory milestones.  It is eligible to receive an additional EUR550 million subject to sales milestones, making the total value of the deal up to EUR1.165 billion.  Additionally, Nanexa is eligible to receive low single-digit royalties on global net sales of products developed under the agreement.

Nanexa’s PharmaShell® technology involves encapsulation of an active pharmaceutical ingredient with an ultra-thin coating using Atomic Layer Deposition.  The coating can be tailored to achieve precise, controlled and sustained release of the active pharmaceutical ingredient.

In December 2025, Nanexa entered into a licence and option agreement with Moderna for the use of its PharmaShell® technology for a selected compound, with options for up to four additional compounds.  Nanexa received an upfront payment of USD3 million, with up to USD500 million in potential milestone payments, as well as a tiered single-digit royalties on future product sales.

On 24 September 2026, Eli Lilly announced that the FDA has approved Onswik™ (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adult treatment of type 2 diabetes.  It is indicated for use as an adjunct to diet and exercise to control high blood sugar and will be available in a KwikPen® (500 units/mL and 1000 units/mL) “in the coming months”.

The FDA approval was based on positive results from the QWINT Phase 3 trials.  The trials evaluated the safety and efficacy of once-weekly Onswik™ in over 3400 patients across four studies (QWINT-1, QWINT-2, QWINT-3 and QWINT-4).  In each QWINT trial, Onswik™ met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to Sanofi’s Lantus® (insulin glargine) or Novo Nordisk’s Tresiba® (insulin degludec).

According to Eli Lilly, the US approval for Onswik™ follows positive regulatory action in Europe (CHMP recommendation in June 2026), Japan (PMDA approved in September 2026) and Mexico.

Onswik™ is the second once-weekly basal insulin approved by the FDA.  Novo Nordisk’s Awiqli® (insulin icodec-abae) injection was the first once-weekly basal insulin for adults with type 2 diabetes to receive FDA approval (March 2026).  It was launched in August 2026 as a pre-filled pen (700 units/mL).

On 23 September 2026, Mylan filed a Complaint in the US District Court for the District of Delaware seeking a declaration of non-infringement and invalidity in relation to Novo Nordisk’s U.S. Patent No. 12,551,536.  The patent was granted on 17 February 2026 and relates to a method for reducing body weight by subcutaneous administration of 2-10 mg semaglutide weekly.

Mylan has filed an abbreviated new drug application (ANDA) with the FDA (on an unidentified date) seeking approval to market semaglutide prefilled single dose pens.  In its Complaint, Mylan alleges that it has a reasonable apprehension that Novo Nordisk will sue Mylan for infringement of the US ‘536 patent.  This is on the basis that the US ‘536 patent is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) for Wegovy®, but Novo Nordisk did not initiate litigation concerning that patent within 45 days of receiving a notice on 17 June 2026 stating Mylan believes no valid claim of the US 536 patent will be infringed by exploitation of its generic semaglutide product.

Mylan claims the US ‘536 patent is invalid on a number of grounds, including lack of novelty and obviousness and asks the Court to declare that the exploitation of Mylan’s generic semaglutide products will not infringe the ‘536 patent.

Novo Nordisk has previously sued Mylan for infringement of a number of US semaglutide patents, including in 2023 (five patents, including US 9,764,003), 2024 (US 12,029,779) and 2025 (US 12,214,017).  On 22 July 2025, the US District Court in Delaware ruled on the pleadings that Mylan did not induce infringement of the US ‘003 method of treatment patent in connection with its generic Wegovy® products.

Novo Nordisk has US patent infringement litigation pending against a number of other companies, including Apotex, Cipla and Sun Pharma, in relation to their generic semaglutide products.

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.

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 21 September 2026, Roche announced that the European Commission (EC) has approved Susvimo® (ranibizumab) as a 100 mg/mL solution for injection for the treatment of neovascular age-related macular degeneration (nAMD).

The European approval follows the CHMP’s positive opinion for Susvimo® in July 2026.  Susvimo® is delivered via an ocular implant, marketed as Contivue® in the EU, for continuous release into the vitreous of the eye.  The Contivue® devices include a refillable implant surgically inserted into the eye during a one-time, outpatient procedure.  Contivue® also includes four ancillary devices to initially fill, insert, refill, and remove the implant

Susvimo® was approved in the US for nAMD in July 2024, diabetic macular oedema in February 2025 and diabetic retinopathy in May 2025.  In the US, the devices and medicine (ranibizumab) are approved as a single product.

The US approvals followed an update and relaunch of the product, after Roche conducted a voluntary recall of the initial version (FDA approved in October 2021) as a result of test results showing some implants did not perform to Roche’s standards.

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.

September 2026 has been a busy month for ranibizumab with two new registrations on the Australian Register of Therapeutic Goods (ARTG): Novartis’ Vurjor® (1.65mg/0.165mL solution prefilled syringe (18 September)) and Roche’s Susvimo® (100mg/mL solution for injection vial for use with the Contivue® ocular implant (24 September)).

Vurjor® is a new brand for Novartis, with all of Novartis’s previous ranibizumab ARTG registrations under its Lucentis® brand.  Novartis is yet to seek listing of Vurjor® on the Pharmaceutical Benefits Scheme (PBS).  Vurjor® is approved for the same indications as Lucentis® for the treatment of adults.

Roche’s Susvimo® is delivered via an ocular implant, marketed as Contivue®, for continuous release into the vitreous of the eye.  It is indicated for the treatment of adult patients with nAMD who have previously responded to at least two intravitreal injections of vascular endothelial growth factor (VEGF) inhibitors.

Roche has applied to list Susvimo® on the PBS.  The Pharmaceutical Benefits Advisory Committee (PBAC) had previously decided against recommending PBS-listing of Susvimo® at its May 2026 meeting, on the basis that Roche was seeking TGA approval for an updated version of the port delivery system.  Roche has resubmitted its request for PBS-listing of Susvimo®, which will be considered by PBAC at its November 2026 meeting.

There are currently two ranibizumab biosimilars approved in Australia: Actor Pharmaceuticals’ Raniviz® in 1.65mg/0.165mL PFS (TGA-approved in February 2026), and Samsung Bioepis’ Byooviz® (approved August 2022).  Actor has applied for PBS listing of its biosimilar ranibizumab, as has Generic Health in relation to Solentis® and Simulara® in 1.65mg/0.165mL PFS and 2.3mg/0.23mL PFS (not yet TGA-approved).  Those PBS applications will be considered at the November PBAC meeting.