On 16 July 2026, Organon and Samsung Bioepis announced the expansion of their development and commercialisation agreement for Australia, to include a new biosimilar.  While the biosimilar has not been named by Organon or Samsung Bioepis, Pharma in Focus has suggested that it may be Epyztek®, biosimilar to J&J’s Stelara® (ustekinumab).

Under the terms of the expanded agreement, Organon will obtain the exclusive Australian commercialisation rights to the biosimilar, while Samsung Bioepis will maintain full development, manufacturing and regulatory responsibilities.

Samsung Bioepis’ Epyztek® (ustekinumab) was approved in Australia in October 2024 and was recommended for PBS-listing at PBAC’s March 2025 meeting.  The drug has not yet been PBS-listed pending lodgement of required documentation.

In October 2025, Samsung Bioepis successfully opposed Janssen’s Australian patent application (AU2019346134) relating to a method of treating ulcerative colitis (UC) with Stelara® (ustekinumab).

This followed a decision of the Federal Court of Australia in June 2025, ordering that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016).  In an earlier victory for Samsung Bioepis, Janssen surrendered two innovation patents (AU 2023100041 and 2023100042), which related to methods of treating UC with ustekinumab.

Organon is currently sponsoring three of Samsung Bioepis’ biosimilars in Australia under the existing agreement: Brenzys® (etanercept), which was TGA-approved July 2016 and PBS-listed July April 2017; Renflexis® (infliximab), TGA-approved November 2016 and PBS-listed August 2017; and Hadlima® (adalimumab), TGA-approved in January 2018, launched March 2021 and PBS-listed in April 2021.

In June 2026, the companies announced the expansion of their Canadian collaboration, first established in 2013, from five to six biosimilars to include Pyzchiva®, biosimilar to J&J’s Stelara (ustekinumab).

On 16 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its international multicentre Phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab).

Henlius received approval from China’s National Medical Products Administration for the investigational new drug (IND) application for HLX18 in March 2026.  This followed FDA approval of the HLX18 IND application in December 2025.

The Phase 1 study, initiated in June 2026, is designed to evaluate the similarity in pharmacokinetic profile, efficacy, safety and immunogenicity of HLX18 and BMS’ Opdivo® in patients with resected oesophageal or gastroesophageal junction cancer, melanoma or urothelial carcinoma.  Primary completion of the study is expected in August 2027.

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 Zydus’ ZRCr-4276.  In June 2026, Orion Pharma announced it entered into an agreement with Shilpa Biologicals for the European commercialisation of Shilpa’s intravenous nivolumab biosimilar, which is currently under development.

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.

On 15 July 2026, Sun Pharma announced that the South African Health Products Regulatory Authority (SAHPRA) has approved its semaglutide injection, generic equivalent of Novo Nordisk’s Ozempic® (semaglutide) for the treatment of adults with type 2 diabetes mellitus.  The launch is expected to occur in the coming days.

The semaglutide injection was approved as a pre-filled, multi-dose injectable pen in two strengths (2 mg/1.5 mL and 4 mg/3 mL) for once-weekly treatment of adult patients as an adjunct to diet and exercise.  This is the second market to date, following India, where Sun Pharma’s generic semaglutide has received approval.

On 18 July 2026, Business Insider Africa announced that Novo Nordisk is partnering with Swiss pharmaceutical company, Acino, to launch Extensior™, a lower-cost version of Ozempic® (semaglutide) on 27 July 2026 in South Africa.  Extensior™ will be available in 0.25mg, 0.5mg and 1mg doses in the same injection device as Ozempic®.  This followed Novo Nordisk securing an interim order from the Gauteng High Court preventing iDexis from manufacturing and selling compounded semaglutide medicines in South Africa in June 2026.  iDexis has appealed the court order and decisions made by SAHPRA and the South African Pharmacy Council.

A number of generic semaglutide products have already launched in India and Canada.  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 launched in 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.

Novo Nordisk has recently launched alternative semaglutide formulations globally.  Novo Nordisk’s Wegovy® pill was the first oral GLP-1 treatment recommended for approval by CHMP for weight management in the EU.  Marketing authorisation for the Wegovy® pill and Wegovy® 7.2mg injection in a single-dose pen was granted by the European Commission on 15 July 2026.  This followed the first-in-world US approval of the oral formulation by the FDA on 23 December 2025 and US launch of the Wegovy® pill on 5 January 2026.

On 15 July 2026, Celltrion announced that South Korea’s Ministry of Food and Drug Safety (MFDS) has approved its investigational new drug application to commence a Phase 1 clinical trial of CT-P68, biosimilar to Janssen’s Tremfya® (guselkumab).

The Phase 1 trial will assess the safety and pharmacokinetic equivalence of CT-P68 and Tremfya® in 258 healthy adults.

No guselkumab biosimilars have yet been approved in any major market.  Guselkumab biosimilars are being developed by Polpharma Biologics, whose PB019 is licensed to MS Pharma in the MENA region, and Samsung Bioepis.  Alvotech also has a proposed guselkumab biosimilar in development, partnered with Advanz Pharma for commercialisation in the EU, UK and Switzerland.

On 14 July 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety (MFDS) is implementing a revised notice on the Regulation on Approval and Review of Biological Products.  The revisions permit Phase 3 clinical trial data to be waived for biosimilar approval applications if equivalence with the reference drug is sufficiently demonstrated through quality, non-clinical, and pharmacokinetic studies.

The change is aimed at accelerating biosimilar development and aligning Korean regulations with global standards.  The European, US and Canadian regulatory agencies have adopted similarly reduced requirements for Phase 3 clinical trial data, as follows:

• At its meeting from 23-26 March 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a reflection paper which considers that, in certain circumstances, analytical comparability and pharmacokinetic data may be sufficient for approval of biosimilars, with Phase 3 trial data no longer required;
• On 9 March 2026, the FDA issued a new draft guidance on biosimilar development and the BPCIA aimed at reducing upfront research and development timelines and costs for biosimilar developers and lowering the cost of medicines for consumers.  In the new draft guidance, FDA “recommended streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified” stating that “this change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million, and help lower drug costs.”
• On 19 May 2026, Health Canada published its revised Guidance on Information and Submission Requirements for Biosimilar Biologic Drugs, providing that comparative clinical efficacy studies are not typically required for a biosimilar to a Canadian reference biologic drug when the biosimilar has been compared and extensively characterised by analytical and clinical pharmacology studies.

Biosimilar developers are taking advantage of the reduced Phase 3 trial requirements globally, including Celltrion streamlining its US Phase 3 trial for biosimilar pembrolizumab and EU Phase 3 biosimilar secukinumab trial, Sandoz streamlining its nivolumab and ocrelizumab biosimilar trials and minimising its Phase 3 biosimilar pembrolizumab trial, and Formycon voluntarily terminating its Phase 3 clinical trial for biosimilar pembrolizumab.

On 14 July 2026, Formycon and OneSource Speciality Pharma announced that they have entered into a strategic manufacturing partnership for biosimilars.  OneSource is an Indian-based specialty pharma Contract Development & Manufacturing Organisation (CDMO) that provides end-to-end services for complex pharmaceutical products.

Under the partnership, OneSource will provide integrated drug substance and drug product manufacturing capabilities from its biologics facility in Bangalore, to support the development of Formycon’s biosimilar programs for global markets.

Formycon’s CEO, Dr Stefan Glombitza, stated that “by adding OneSource to our network of strategic manufacturing partners, we are further strengthening our supply capabilities”.  Neeraj Sharma, OneSource’s Managing Director & CEO, added that this partnership “…reinforces our belief that India is uniquely positioned to serve as a global hub for the development and manufacturing of world-class biologics”.

In June 2025, Sweden-based Xbrane Biopharma and OneSource entered into a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio.

On 14 July 2026, ChosunBiz reported that Celltrion has voluntarily terminated the European Phase 3 trial of CT-P51, biosimilar to MSD’s Keytruda® (pembrolizumab), and has withdrawn its investigational new drug application.  The early termination of the trial in Europe is part of Celltrion’s strategy to streamline its development program for the biosimilar.

Celltrion’s strategy follows a “reflection paper” published by the European Medicines Agency in April 2025, and adopted by the Committee for Medicinal Products for Human Use (CHMP) in March 2026, which considers that, in certain circumstances, analytical comparability and pharmacokinetic data may be sufficient for approval of biosimilars, with Phase 3 trial data no longer required.

Celltrion has also recently streamlined its US Phase 3 trial for CT-P51 (pembrolizumab), having filed with the FDA an amendment to reduce the number of trial participants from about 600 to around 220.  The US Phase 3 trial plan was originally approved by the FDA in August 2024 and aims to compare the efficacy and safety of CT-P51 and Keytruda® in patients with previously untreated metastatic non-squamous non-small cell lung cancer.  The trial will be conducted over a period of 2 years.

Celltrion’s revisions to its Phase 3 trial strategy comes shortly after Samsung Bioepis announced positive results from its global Phase 1 and Phase 3 clinical trials for SB27 (pembrolizumab).  According to Samsung Bioepis, it was the first developer of a pembrolizumab biosimilar to announce global Phase 3 trial results.

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, Bio-Thera, 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 14 July 2026, Merck KGaA announced that Erbitux® (cetuximab) was approved by the European Commission for adults with BRAF V600E mutant metastatic colorectal cancer (mCRC) in combination with Pierre Fabre’s Braftovi® (encorafenib) and FOLFOX (fluorouracil, leucovori, and oxaliplatin) for first line treatment and in combination with Braftovi® in patients who have received prior systemic therapy.  The EC approval follows the CHMP’s positive opinion in May 2026.

Matthias Wernicke, Merck’s Head of Global Therapeutic Area Specialty Care stated this approval “marks an important milestone for patients … as BRAF V600E mutant mCRC is associated with a historically poor prognosis and limited effective options.”  The Erbitux®/Braftovi®/FOLFOX combination received accelerated approval by the FDA in December 2024 and traditional approval in February 2026 for the same indication.

Merck KGaA licensed the right to market Erbitux® outside the US and Canada from ImClone LLC, a wholly-owned subsidiary of Eli Lilly, in 1998.

No cetuximab biosimilars have been launched to date in China, the United States, Europe or Japan.  Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched in India (January 2023 and May 2023, respectively).  Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™.  In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.  On 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China had been dosed in a multicentre Phase 1 clinical trial of its cetuximab biosimilar, HLX05-N.

On 13 July 2026, Seoul Economic Daily reported that Samsung Bioepis has secured US formulary listings for Pyzchiva®/SB17, with two major pharmacy benefit managers (PBMs).

Pyzchiva® was listed as a preferred drug by CVS Caremark from 1 July 2026, following the inclusion of Pyzchiva® on the Express Scripts (ESI) formulary earlier this year.  According to the announcement, CVS Caremark and ESI cover 57% of the US PBM market, broadening patient access.

Samsung Bioepis also supplies private label versions of Pyzchiva® through agreements with distribution subsidiaries of these PBMs, including Quallent (an ESI subsidiary) and Cordavis (a CVS Caremark subsidiary).  The private label versions of Pyzchiva® are supplied under the proprietary brands of the PBM subsidiaries.

The reference drug, J&J’s Stelara® (ustekinumab) is excluded from major formularies in the US.  In May 2026, it was reported that from 1 July 2026, CVS Health would preference lower-cost, interchangeable biosimilars over Stelara® in its most common drug lists.  CVS Health’s pharmacy benefit management unit, Caremark, will transition to biosimilar versions of Stelara®, such as Sandoz/Samsung Bioepis’ Pyzchiva® and Biocon Biologics’ Yesintek™.

Pyzchiva® was developed by Samsung Bioepis and is commercialised by Sandoz in the US pursuant to a deal entered into in September 2023.  The FDA approved Pyzchiva® in July 2024 for multiple indications, including plaque psoriasis, active psoriatic arthritis, Crohn’s disease and ulcerative colitis.

There are currently seven other FDA-approved ustekinumab biosimilars in the US market: Amgen’s Wezlana® (FDA-approved October 2023; launched January 2025), Dong-A ST/Accord BioPharma’s Imuldosa® (FDA-approved October 2024; launched August 2025; added to ESI’s commercial formulary December 2025), Alvotech/Teva’s Selarsdi® (FDA-approved April 2024; launched February 2025; interchangeability status May 2025), Biocon’s Yesintek® (FDA-approved in December 2024; launched February 2025), Formycon/Fresenius Kabi’s Otulfi® (FDA-approved September 2024; launched March 2025), Celltrion’s Steqeyma® (FDA-approved December 2024; launched March 2025) and Hikma’s Starjemza™ (FDA-approved May 2025; launched November 2025).

On 13 July 2026, Shanghai Henlius Biotech announced that the first patient in the US has been dosed in its international multicentre Phase 1 clinical trial of HLX-15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.

Shanghai Henlius’ Investigational New Drug (IND) application for the Phase 1 trial was approved by the FDA in February 2026, shortly after approval by China’s National Medical Products Administration.  The first patient in China was dosed in May 2026.

The Phase 1 study, initiated in May 2026, is designed to evaluate the pharmacokinetic similarity, safety, tolerability, immunogenicity and efficacy of HLX15-SC compared to US-Darzalex Faspro® following single and multiple subcutaneous injections in newly diagnosed multiple myeloma patients ineligible for transplant.  Primary completion of the study is expected in May 2027.

Henlius is also developing an IV form of HLX15, having completed a successful Phase 1 clinical trial of HLX15-IV against US, EU and CN sourced Darzalex® (daratumumab) in June 2024.

Both SC and IV forms of HLX15 will be exclusively commercialised by Dr Reddy’s in Europe and the US under the terms of a licence agreement announced in February 2025.

The first reported regulatory approval for a daratumumab biosimilar worldwide was announced by BIOCAD in August 2025 for Russian approval of Daratumia®.  Daratumumab biosimilars are under development, including by CSPC Pharmaceutical Group, which obtained approval in December 2025 to conduct clinical trials in China of its Daratumumab Injection, and Celltrion, whose Phase 3 clinical trial plan for CT-P44 (daratumumab) was approved in Europe in September 2025.