Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Filter by Categories
BioBlast®
Biosimilars Deals 2023
Diversity
Masterclasses
Other Podcasts
Other Updates
Our Awards
Patent Case Summaries
Patent Litigation
Patents
PipCast®
PTE
Trade Marks
Webinars

Home / News / BioBlast®

EXPLORE OUR

BioBlast®

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.
Scientific Name: cetuximab

2024

February 19, 2024

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: 

New Listings  Amendment Applications  
Janssen-Cilag’s Stelara® (ustekinumab)  Sanofi-Aventis’s Dupixent® (dupilumab) 
Amgen’s Wezlana® (ustekinumab)  Bristol-Myers Squibb’s Opdivo® (nivolumab) 
Bayer’s Eylea® (aflibercept)  Merck’s Erbitux® (cetuximab) 
AstraZeneca’s Enhertu® (trastuzumab deruxtecan)  AbbVie’s Humira® (adalimumab) 
Celltrion’s Vegzelma® (bevacizumab)   
Celltrion’s Yuflyma® (adalimumab)   
AstraZeneca’s Saphnelo® (anifrolumab)   
Roche’s Tecentriq® (atezolizumab)   
UCB’s Bimzelx® (bimekizumab)   

 

 

 

 

 

 

 

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). 

2023

June 1, 2023

Innovent announced that it has entered into a clinical trial collaboration and supply agreement with Merck 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 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. 

May 30, 2023

Lupin announced a strategic collaboration with Enzene Biosciences (Aklem Laboratories’ biological arm) to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and Merck’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.   

2022

November 30, 2022

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).

October 12, 2022

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

August 11, 2022

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.

July 18, 2022

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.

June 22, 2022

AVEO Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab) in the US and Canada in patients with recurrent or metastatic head and neck squamous cell carcinoma.  This follows a similar engagement with Merck earlier in 2022 regarding Aveo’s clinical development plan for ficlatuzumab.

May 23, 2022

Biond Biologics announced the first patients have been dosed in its Ph I trials of BND-22 (an Ig-Like Transcript 2 (ILT2) receptor blocking antibody) in combination with pembrolizumab or cetuximab being conducted in Israel and the US.  BND-22 is being developed under an exclusive world wide licence with Sanofi.

March 28, 2022

Medical Xpress reports on an Institute of Cancer Research, London, study showing that levels of the protein PD-L1 detected in head and neck tumours can be used to personalise medicine.  Depending on PD-L1 levels, patients should receive personalised medicine of either chemotherapy with or without cetuximab, pembrolizumab in combination with chemotherapy, or pembrolizumab alone.

2021

September 28, 2021

Eli Lilly announced that the FDA has approved Erbitux® (cetuximab) in combination with Braftovi® (encorafenib) for the treatment of metastatic colorectal cancer with a BRAF V600E mutation.

July 29, 2021

A new study published in Lancet Oncology reported that pembrolizumab in combination with cetuximab shows promise as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.

April 13, 2021

NKMax and Merck KGaA announced an expansion of its clinical trial and supply agreement to include a Ph I/IIa trial of SNK01 in combination with Erbitux® (cetuximab) in patients with locally advanced or metastatic non-small cell lung cancer.

April 6, 2021

The FDA approved a new dosage regimen for Erbitux® (cetuximab) for patients with K-RAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The new dosage regimen allows for fortnightly dosing.

2020

August 10, 2020

AVEO Oncology releases its Q2 FY2020 earnings report. AVEO reported data from its Ph I study of ficlatuzumab and cetuximab in patients with advanced head and neck squamous cell carcinoma (HNSCC) demonstrated that the products have an acceptable safety profile and showed promising anti-tumour activity in a refractory HNSCC patient population. AVEO also announced that it is evaluating the process to secure additional clinical manufacturing of ficlatuzumab to potentially enable a Ph III clinical trial in 2022.

April 8, 2020

Pfizer announces the FDA has approved Braftovi® (encorafenib) in combination with Erbitux® (cetuximab) for the treatment of BRAF600E-mutant metastatic colorectal cancer after prior therapy.

2018

September 18, 2018

Researchers release results of pre-clinical study of cetuximab candidate APZ001. 

January 10, 2018

Amgen discloses at JP Morgan Healthcare Conference that it is in process development for a cetuximab biosimilar.

2016

January 11, 2016

MabTech announces successful Chinese Ph III clinical trials for Sorrento’s “biosimilar/biobetter” cetuximab STI-001, and infliximab STI-002.

BioBlast® extract From January 11, 2016 to February 19, 2024