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BioBlast® w/e 14 Oct 22: BioFactura’s ustekinumab, Prestige’s trastuzumab, Merck/Moderna personalised cancer vaccine combo, Regeneron’s aflibercept, Jacobio Pharma/Merck’s cetuximab, Janssen’s guselkumab/golimumab, Alvotech’s aflibercept

by | Oct 17, 2022

Significant biosimilar activities this week include:

14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable PK to Stelara® in Ph I trial

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BFI-751.  The trial in Australia and New Zealand involved 226 subjects and demonstrated bioequivalence of BFI-751 to the US and EU versions of Janssen’s Stelara.  BioFactura now intends to conduct a Ph III confirmatory safety and efficacy trial in patients.

13 Oct 22 | US | Prestige requests Type 4 meeting with FDA in relation to Tuznue® (biosimilar trastuzumab)

Prestige Biopharma announced that it has submitted a request to the FDA for a pre-submission meeting to discuss the planned BLA for Tuznue® (biosimilar trastuzumab).  Prestige announced that it plans to submit the BLA by the end of the year.

12 Oct 22 | Merck and Moderna collaborating on Personalized Cancer Vaccine under evaluation in combination with KEYTRUDA® (pembrolizumab)

Merck announced that it has exercised its option to jointly develop and commercialise the personalised cancer vaccine mRNA-4157/V940 under the terms of the Collaboration and License Agreement originally signed by Merck and Moderna in 2016.  Moderna is conducting a Phase 2 clinical trial evaluating mRNA-4157/V940 in combination with Merck’s KEYTRUDA® as adjuvant treatment for patients with high-risk melanoma. Primary data are expected in Q4 2022.

12 Oct 22 | US | FDA accepts aflibercept sBLA for treatment of retinopathy of prematurity for Priority Review

Regeneron announced that the FDA has accepted for Priority Review the sBLA for Eylea® (aflibercept) to treat retinopathy of prematurity in preterm infants.   The target action date for the FDA decision is 11 February 2023.

12 Oct 22 | Jacobio Pharma and Merck enter into clinical trial collaboration for JAB21822 and Erbitux® (cetuximab)

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.

10 Oct 22 | Janssen publishes data from guselkumab and golimumab trial

Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis.  Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a higher clinical remission rate than induction and maintenance treatment with either guselkumab alone or golimumab alone.

09 Oct 22 | Phase III study for Alvotech’s AVT06 (biosimilar aflibercept) to proceed in India

India’s Central Drug Standard Control Organisation granted permission to IQVIA to conduct Ph III clinical trials of Alvotech’s AVT06 (biosimilar aflibercept) for the treatment of retinal vascular diseases.

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