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 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 8 July 2026, Shanghai Henlius Biotech announced that the first patient in China has been dosed in its multicentre Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab).

The Phase 1 study, initiated in June 2026, is designed to evaluate the pharmacokinetic similarity, efficacy, safety and immunogenicity of HLX05-N compared with US- and EU-sourced Erbitux® in patients with metastatic colorectal cancer (mCRC).  Primary completion of the study is expected in June 2027.

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

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 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including positive opinions for one biosimilar, one “hybrid” medicine and recommended extended indications for a number of biopharmaceuticals.

Lupin’s Vislyfa® (ranibizumab), biosimilar to Genentech’s Lucentis®, was the only biosimilar to receive a positive opinion this month.  There is already a Lupin-developed biosimilar approved in Europe, Ranluspec® (approved February 2026, with planned EU launch in the second half of 2026). Under an August 2025 agreement, Sandoz is commercialising Ranluspec® in the EU (excluding Germany), Switzerland, Norway, Canada, Australia, Hong Kong, Vietnam and Malaysia.  Other ranibizumab biosimilars approved and launched in Europe include Samsung Bioepis’ Byooviz® (approved August 2021 and commercially available in several European countries since March 2023), STADA/Xbrane’s Ximluci® (launched in the EU in April 2023, following November 2022 approval) and Formycon’s Ranivisio® (approved August 2022, being commercialised in the EU by Teva).  Intas’ Rexatilux® (ranibizumab) received a positive CHMP opinion in April 2026.

STADA received positive recommendations for its “hybrid” liraglutide products Ablymico® and STADA Liraglutide™, indicated for weight management and type 2 diabetes, respectively.  The EMA categorises a medicine as “hybrid” where it is similar to an authorised medicine containing the same active substance, but where there are certain differences between the two medicines such as in their strength, indication or pharmaceutical form.  Ablymico® is a hybrid medicine of Novo Nordisk’s Saxenda® (liraglutide), in that it contains the same active substance, but it is chemically synthesised, whereas the active substance of Saxenda® is of biological origin.  For the same reason, STADA Liraglutide™ is a hybrid medicine of Novo Nordisk’s Victoza® (liraglutide).

The CHMP’s May 2026 positive opinions for extended indications include:

• AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan): for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment and who have no satisfactory treatment options;
• Merck KGaA’s Erbitux® (cetuximab): for adults with BRAF V600E mutant metastatic colorectal cancer in combination with encorafenib and FOLFOX for first line treatment and in combination with encorafenib in patients who have received prior systemic therapy;
• AstraZeneca’s Fasenra® (benralizumab): as an add‑on treatment for adult and adolescent patients aged 12 years and older weighing at least 35 kg with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause;
• Shanghai Henlius/Accord’s Hetronifly® (serplulimab): in combination with carboplatin and nab-paclitaxel, for first-line treatment of adults with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma;
• MSD’s Keytruda® (pembrolizumab): in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for treatment of adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin‑containing chemotherapy;
• MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase-alfa): indications extended to adolescents in relation to melanoma and classical Hodgkin Lymphoma; and
• Astellas’ Padcev® (enfortumab vedotin): in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

Celltrion withdrew its EU marketing authorisation application for Veblocema™ (infliximab) for the treatment of rheumatoid arthritis, Crohn’s disease and ulcerative colitis “due to a change in business strategy”, while Laboratoires Delbert withdrew its application for Orblid™ (bevacizumab) for treatment of hereditary haemorrhagic telangiectasia, due to identification of major clinical issues which could only be addressed by carrying out a new clinical study.

On 10 May 2026, Shanghai Henlius Biotech announced that the FDA has approved an Investigational New Drug (IND) application for a Phase 1 clinical trial of HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastatic colorectal cancer (mCRC).

This follows approval of Henlius’ IND application for HLX05-N by China’s National Medical Products Administration in April 2026 for the same indication.

Cetuximab biosimilars have been approved and launched in India (Alkem’s Cetuxa™ approved January 2023, launched May 2023), China (Simcere Zaiming/Mabpharm’s Enlituo® (cetuximab beta) approved June 2024) and Russia (R-Pharm’s Arcetux™ approved February 2026).

On 14 April 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for HLX05-N, biosimilar to Eli Lilly/Merck KGaA’s Erbitux® (cetuximab), for the treatment of metastatic colorectal cancer (mCRC).

According to Henlius, it now plans to commence an international multicentre Phase 1 clinical study of HLX05-N “once the necessary conditions are met”.

Other cetuximab biosimilars have been approved globally, primarily for the treatment of mCRC and head and neck squamous cell carcinoma (HNSCC).  Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched, having been approved in India in January 2023 and launched in May 2023.  Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™.  Simcere Zaiming/Mabpharm’s Enlituo® (cetuximab beta) was approved in China in June 2024.  In February 2026, R-Pharm’s Arcetux™ (cetuximab) was the first biosimilar cetuximab to gain approval in Russia.

On 4 February 2026, R-Pharm announced it has obtained Russian marketing authorisation for the anti-cancer drug Arcetux™, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab).  This is the first biosimilar cetuximab to be approved in Russia.

Arcetux™ has been approved for two indications, local head and neck cancer treatment and metastatic colorectal cancer.  Cetuximab is listed on the Russian Vital and Essential Drugs (VED) list, which allows for increased accessibility for patients.

The approval follows R-Pharm’s announcement in December 2025 at the 29th Russian Oncology Congress that Arcetux™ had completed Phase III trials.

Alkem’s Cetuxa™ was reportedly the first cetuximab biosimilar to be approved and launched globally, having been approved in India in January 2023 and launched in May 2023.  Alkem’s biological arm, Enzene, entered into a strategic collaboration with Lupin in May 2023 for Indian commercialisation of Cetuxa™.  Sincere Pharmaceutical/Mabpharm’s Enlituo® (cetuximab beta) was approved in China in June 2024.

On 22 December 2025, R-Pharm announced that it has presented its progress on two biosimilar products at the 29th Russian Oncology Congress: Persinthia®, biosimilar to Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer; and Arcetux®, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab), for treatment of head and neck tumours.  Both biosimilars have completed Phase III trials and R-Pharm expects they will gain registration in Russia in 2026.

Biocad already has Russian approval for a pertuzumab biosimilar.  Pertuzumab biosimilars have also been approved in at least the US (Shanghai Henlius) and India (Enzene, Zydus and Intas).

Roche has recently indicated that biosimilar competition to Perjeta® (pertuzumab) is a bigger concern than it previously anticipated.  Roche is also taking legal action in India to prevent biosimilar competition to Perjeta® from Zydus’ Sigrima® product, with the High Court of Delhi issuing an interlocutory judgment in July 2025.

Further pertuzumab biosimilars are under development – Sandoz and EirGenix have a commercialisation deal in place for EG1206A (November 2025) and received positive feedback from both the FDA and the European Medicines Agency, confirming that the product qualifies for an abbreviated development pathway allowing for the waiver of Phase III comparative efficacy trials.

In May 2023, Lupin and Enzene announced a strategic collaboration to launch Cetuxa® in India, as the first biosimilar cetuximab in that country.  In January 2018, Amgen disclosed at the JP Morgan Healthcare Conference that it was in the process of developing a cetuximab biosimilar.

New Zealand’s drug-funding body, Pharmac, has announced that Eli Lilly/Merck KgGa’s Erbitux® (cetuximab) will now be funded for left-sided, RAS and BRAF wild-type, metastatic colorectal cancer.  Minor amendments have also been made to eligibility criteria for currently funded head and neck cancer indications.

Pharmac is still assessing whether funding should also be extended to BRAF-mutated metastatic colorectal cancer and has invited a funding application to be made for cetuximab in combination with encorafenib.  This funding application would require a submission for Medsafe approval of encorafenib which is not yet approved in New Zealand, unlike in the US where this combination therapy has been approved.

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following: 

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab).