On 17 August 2026, Sandoz and Shanghai Henlius Biotech announced that they have entered into a major development, manufacturing and commercialisation collaboration agreement, covering up to 10 biosimilars (including monoclonal antibodies and/or antibody-drug conjugates).

There are three products initially covered by the agreement:

• HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), which is currently in clinical development;
• HLX16, biosimilar to Amgen’s Repatha® (evolocumab), which is in “technical development”; and
• biosimilar belimumab, referencing GSK’s Benlysta®, which is in “early development”.

Sandoz also has an option for HLXTE-HAase1001, a recombinant human hyaluronidase to be used in the development of a subcutaneously administered biosimilar.

Under the terms of the agreement, Henlius will be responsible for biosimilar development and manufacturing, while Sandoz will have certain commercialisation rights for the biosimilars outside of China.  For HLX05-N, Sandoz will have exclusive commercialisation rights in the US, Canada, EU, UK, Switzerland, Japan, Australia and New Zealand, and semi-exclusive rights in certain Asian and other countries.  The exclusive commercialisation territory for HLX16 and the belimumab biosimilar includes all markets worldwide outside China.

Sandoz will pay Henlius an upfront payment, milestone payments and a non-refundable option fee totalling up to US $322 million, with Henlius expected to receive US $100.5 million in 2026.

The companies have previously partnered on HLX13, biosimilar to BMS’ Yervoy® (ipilimumab).  Under an agreement announced in April 2025, Henlius is developing and manufacturing HLX13, while Sandoz has the exclusive commercialisation rights in the US, Europe, Canada, Japan, and Australia.  HLX13 entered clinical trials in November 2025.

On 13 August 2026, Celltrion announced that the FDA has granted fast track designation to CT-P73, an antibody drug conjugate (ADC) for the treatment of patients with recurrent and metastatic cervical cancer who have previously received platinum based chemotherapy.

Fast-track designation is designed to accelerate the development and review of drugs intended to treat serious diseases and address unmet medical needs.  A company that receives fast track designation for a drug may have more frequent meetings with FDA regarding the development plan and collection of data needed to support drug approval, may submit sections of its BLA/NDA for “rolling review” and the drug may be eligible for accelerated approval and priority review if relevant criteria are met.

Celltrion has two other ADCs, CT-P70 and CT-P71, which have also secured FDA fast-track designation.  CT-P70 is being developed for the treatment of non-small cell lung cancer (NSCLC), while CT-P71 is undergoing evaluation in patients with locally advanced or metastatic urothelial carcinoma.  All three ADCs are in phase 1 clinical trials.

On 13 August 2026, Bayer announced that China’s National Medical Products Administration (NMPA) has accepted for review its application for Eylea® (aflibercept) 8 mg (114.3 mg/ml solution) for injection) for the treatment of macular oedma following retinal vein occlusion (RVO).

Eylea® 8 mg is already approved in China for nAMD.  It has been approved to date in more than 60 markets for the treatment of nAMD and diabetic macular oedema (DME), including the US (August 2023).  It is also approved for the treatment of patients with macular oedema following RVO including in the US (November 2025), Europe (January 2026), the UK (February 2026), Korea (February 2026) and Japan (March 2026).

Eylea® 8 mg, known in the US as Eylea HD®, was jointly developed by Bayer and Regeneron.  Regeneron holds the exclusive rights to both 2 mg and 8 mg Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

Alvotech is developing a high dose aflibercept biosimilar, AVT29.  In June 2024, Alvotech entered into an agreement with Advanz Pharma in relation to the commercialisation of AVT29 in Europe.  Teva holds commercialisation rights for AVT29 (and AVT06, aflibercept 2 mg) in the US.  Alvotech indicated in March 2026 that it expects to file the first regulatory submission for AVT29 sometime in 2026.  In April 2026, Alvotech commenced a phase 3 clinical trial to evaluate the efficacy and safety of AVT29 compared with Eylea HD® in patients with DME, with an estimated completion date of January 2028.

Amgen is also developing an 8 mg aflibercept biosimilar, ABP 938, and commenced a phase 3 clinical trial in May 2026, with an estimated completion date of January 2028.

On 11 August 2026, Mabwell announced that it has entered into licensing and commercialisation agreements with unidentified partners in the Philippines, Vietnam and Malaysia for 9MW0813, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg.

Under the terms of the agreements, Mabwell and its partners will work collaboratively to advance the product’s registration and commercialisation in each country.  The announcement did not disclose the partners, financial terms or expected timeline for launch.

Mabwell’s biosimilar aflibercept was approved by China’s National Medical Products Administration (NMPA) in September 2025 for the treatment of diabetic macular oedema and neovascular (wet) age-related macular degeneration.

Mabwell has previously entered into licensing and commercialisation agreements for its denosumab biosimilars (Maiweijian™/9MW0321 and Mailishu™/9MW0311, biosimilars to Amgen’s Xgeva® and Prolia®) in the Philippines (July 2025 with UNILAB), Vietnam (March 2026 with undisclosed company) and Malaysia (April 2026 with undisclosed company).  Under these agreements, Mabwell is responsible for the development, production and commercial supply of the products whilst the partner is responsible for registration, marketing and commercialisation.

On 10 August 2026, Samsung Bioepis announced that it has applied to Korea’s Ministry of Food and Drug Safety for approval of SB27, biosimilar to MSD’s Keytruda® (pembrolizumab).  According to Samsung Bioepis, this application puts it ahead of competitor pembrolizumab biosimilars in the Korean product approval process.

Samsung Bioepis announced positive results from global phase 1 and 3 clinical trials for SB27 on 29 June 2026, confirming its equivalence with Keytruda®.  At the time, Samsung Bioepis said it was the first developer of a pembrolizumab biosimilar to announce global phase 3 trial results.  The phase 1 and phase 3 trials were commenced in 2024, in an “overlap strategy” designed to accelerate SB27 development, with the studies expected to be completed by the end of 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.  Formycon’s FYB206 demonstrated pharmacokinetic bioequivalence with Keytruda® in the Phase 1 “Dahlia” study (reported in February 2026).  Formycon’s US commercialisation partner, Zydus, has previously expressed 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, Qilu Pharmaceutical 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 10 August 2026, Samsung Bioepis announced the European launch of Opuviz®/SB15 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea® 2mg in a pre-filled syringe (PFS) presentation (40 mg/mL).  Opuviz® was the third aflibercept biosimilar to be approved in the EU in November 2024 and was launched in Europe in a vial form in May 2026.

The original launch of Opuviz® followed a settlement agreement between Samsung Bioepis and Regeneron/Bayer announced in January 2026 under which Samsung Bioepis was permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement from May 2026 (excluding Korea where it had already been on the market as Afilivu® since 2024).  Samsung Bioepis has a separate settlement agreement with Regeneron/Bayer for North America, permitting launch of SB15 in the US from January 2027.

Opuviz™ was the third aflibercept biosimilar to be approved in the EU (in November 2024) and has been approved elsewhere, including the UK (April 2025), the US (May 2024), Korea (as Afilivu®) (February 2024) and Australia (September 2025).

Other aflibercept biosimilars launched in UK/Europe, including in PFS form, include Sandoz’s Afqlir® (UK launch in November 2025), Celltrion’s Eydenzelt® (UK/EU launch in December 2025), Biocon’s Yesafili® (UK launch in January 2026), Alvotech’s Mynzepli® (UK launch January 2026) and Formycon/Klinge’s Ahzantive®/Baiama® (EU launch in May 2026).

On 10 August 2026, Amneal Pharmaceuticals announced the completion of its acquisition of Kashiv BioSciences.  This follows the companies entering into a definitive agreement in April 2026, and is in line with their expectations of a H2/2026 closing.

The acquisition combines Kashiv’s expertise in biosimilar development and manufacturing with Amneal’s scale and commercialisation capabilities.  According to Amneal, it creates “an integrated biosimilars business that can launch multiple biosimilars each year” and extend Amneal’s “growth profile into the next decade”.

The acquisition included a USD $375 million cash transaction and USD $375 million in equity payable at closing, with up to USD $350 million based on achievement of certain regulatory milestones, potential royalties based on commercial milestones, and funding of operations through closing.

Kashiv and Amneal have previously entered strategic partnerships in relation to biosimilars in the US, including Fylnetra™ (biosimilar pegfilgrastim) in May 2022 and ADL018 (biosimilar omalizumab) in 2024.

The acquisition brings together Kashiv’s biosimilar pipeline (including Releuko™ (filgrastim-ayow) (FDA-approved March 2022), abatacept/KSHB002 (in clinical trials), certolizumab pegol and nivolumab (pre-clinical) and pembrolizumab (cell line and process development)) with Amneal’s biosimilar pipeline (including Alymsys® (bevacizumab) (FDA approved April 2022) and the exclusive US rights to mAbxience’s Boncresa™ and Oziltus™ (MB09), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) (FDA approved December 2025)).

On 6 August 2026, Replimune announced that its vusolimogene oderparepvec-wtpg, formerly known as RP1 but newly branded as Tudriqev™, has received accelerated approval from the FDA for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.

Tudriqev™ is a is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that is administered via direct intra-tumour injection into superficial and deep and/or visceral lesions.

The FDA approval comes despite the FDA’s 30 July 2026 briefing document for Replimune’s third submission of the Biologics License Application (BLA) for RP1 in combination with BMS’ Opdivo® (nivolumab) for the treatment of advanced melanoma.

The FDA’s briefing document stated in relation to Replimune’s IGNYTE study:

• The study’s “criteria for response assessment confounds interpretation of the reported efficacy results and limits FDA’s ability to verify the reported results”;
• “The objective response data from the single-arm IGNYTE study are not of sufficient magnitude to overcome concerns about the contribution of effect, particularly in the absence of a reliable historical control, and therefore it cannot be determined whether RP1 contributes to any observed effect when administered in combination with nivolumab”; and
• “The overall survival analysis from the single-arm IGNYTE study is not interpretable”.

According to Replimune, continued approval of Tudriqev™ may be contingent on verification of its clinical benefit in confirmatory trials.  A confirmatory Phase 3 trial, IGNYTE-3, is ongoing and assessing Tudriqev™ in combination with nivolumab (NCT06264180).

On 5 August 2026, Novo Nordisk announced that The Hague District Court granted a preliminary injunction (PI) preventing Ceban Ziekenhuisfarmacie B.V. (a retail pharmacy based in the Netherlands) from selling a compounded semaglutide nasal spray under the name Semanova.  To date, no nasal spray formulations of semaglutide have been given regulatory approval anywhere in the world.

Novo Nordisk’s European compound patent for semaglutide (EP 1 863 839) expired in March 2026.  In the Netherlands, Novo Nordisk holds a supplementary protection certificate (SPC) extending patent protection over semaglutide until 19 March 2031.

The court found that Ceban’s nasal spray infringed Novo Nordisk’s Dutch SPC for semaglutide.  As a result, the court has ordered Ceban to cease the infringing activities, remove product listings, disclose commercial supply chain information and reimburse Novo Nordisk’s legal costs.

According to JUVE Patent, Ceban’s defence relied on the pharmacy compounding exemption under Article 54c(e) of the Dutch Patent Act, which permits small-scale compounding for individual patients pursuant to a medical prescription.  The court found that Ceban’s resale of nasal sprays to other pharmacies and registration in the Dutch drug database fell outside of this exemption.

In Europe, Novo Nordisk markets semaglutide as Wegovy® for weight loss (subcutaneous injectable (0.25 mg, 0.5 mg, 1 mg, 1.7 mg or 2.4 mg standard dose or 7.2 mg high dose) or oral pill), and as Ozempic® (once-weekly subcutaneous injectable) and Rybelsus® (once-daily oral pill) for the treatment of type 2 diabetes.

Generic semaglutide products are yet to launch in Europe but have launched in India in March 2026 (including by Dr Reddy’s, Zydus, Alkem, Sun Pharma and Glenmark) and Canada in May 2026 (by Apotex and Dr Reddy’s).  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 and subject to ongoing US patent infringement litigation.

On 3 August 2026, Ono Pharmaceutical reported that Opdivo® (nivolumab) was approved by South Korea’s Ministry of Food and Drug Safety (MFDS) for neoadjuvant treatment of adult patients with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements in combination with platinum-doublet chemotherapy, followed by single-agent as adjuvant treatment after surgery.

Ono retains commercialisation rights for Opdivo® in Japan, South Korea and Taiwan under a 2011 agreement with BMS, while BMS has the rights elsewhere in the world.

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), following the High Court of Delhi’s 12 January 2026 reversal on appeal of a preliminary injunction granted to BMS in relation to the biosimilar.  In July 2026, Biocad’s Nivocad® received marketing approval in Russia.

A number of nivolumab biosimilars are under development including Sandoz’s JPB898, Xbrane/Intas’ Xdivane™, Amgen’s ABP 206, Reliance Life Sciences’ RLS-Nivolumab, Enzene’s candidate, Boan Biotech’s BA1104, NeuClone’s candidate and Shilpa’s intravenous nivolumab biosimilar.  Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Sandoz streamlining its biosimilar nivolumab clinical trials.

BMS’ patent rights for nivolumab are being challenged, including in the EU where EP 3 288 980, for a composition comprising nivolumab for use in a method of treating PD-L1-positive melanoma, was revoked in July 2026 following an opposition by 5 “strawperson” opponents.