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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 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. 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. 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 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. 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. 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.2024
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)
2023
2022
Product specific reports based on extracts from our BioBlast® database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
lecanemab | Leqembi® | Eisai/Biogen
liraglutide | Victoza® /Saxenda® | Novo Nordisk
natalizumab | Tysabri® | Biogen/Elan
olaparib | Lynparza® | AstraZeneca/Merck
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
semaglutide | Wegovy®/Ozempic® | Novo Nordisk
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
ustekinumab | Stelara® | Johnson & Johnson/Janssen
BioBlast® Editor and Contributing Author
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