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). 

Innovent announced that it has entered into a clinical trial collaboration and supply agreement with Merck KgGA for a combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX®).  Innovent says the therapy is a potential treatment for non-small cell lung cancer (NSCLC) which will be tested in a phase Ib clinical trial in Chinese patients with advanced or metastatic NSCLC harbouring KRASG12C mutation. 

In October last year, Merck KgGA entered a clinical trial collaboration with Jacobio Pharma to investigate a combination therapy of JAB-21822 (KRAS G12C inhibitor) with ERBITUX® to treat KRAS G12C-mutated colorectal cancer. 

Lupin announced a strategic collaboration with Enzene Biosciences (Aklem Laboratories’ biological arm) to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and MSD’s Erbitux®.  Cetuximab is approved by Drug Controller General of India for treating head and neck cancer, particularly Squamous Cell Carcinoma of the Head and Neck (SCCHN).  

In February 2023, Enzene Biosciences began supply of its Humira® (adalimumab) biosimilar in India for the treatment of ankylosis spondylitis and rheumatoid arthritis.   

Erasca announced it has signed a clinical trial collaboration and supply agreement with Pierre Fabre for BRAFTOVI (encorafenib) within key international territories.  Erasca reported that this agreement will support a clinical proof-of-concept trial evaluating ERAS-007 (oral ERK1/2 inhibitor) in combination with encorafenib and cetuximab for the treatment of BRAF V600E-mutant metastatic colorectal cancer (mCRC).

Jacobio Pharma announced it has entered into a clinical trial collaboration agreement with Merck KgGA to study Jacobio’s JAB-21822 (KRAS G12C inhibitor) in combination with Erbitux® (cetuximab) for the treatment of KRAS G12C-mutated colorectal cancer.

ALX Oncology announced the initiation of Ph II trials of evorpacept (CD47 blocker) in combination with Erbitux® (cetuximab) and Keytruda® (pembrolizumab) for the treatment of refractory microsatellite stable metastatic colorectal cancer following at least two lines of systemic therapy.

Erasca and Eli Lilly announced that they have entered into a clinical trial collaboration and supply agreement for Erbitux® (cetuximab).  This agreement will support Erasca’s ongoing Ph I trials evaluating ERAS-601, its SHP2 inhibitor, with cetuximab for the treatment of triple wildtype metastatic colorectal cancer and HPV-negative advanced head and neck squamous cell carcinoma.  Lilly will supply cetuximab to Erasca at no cost.