Read our latest updates & insights

MSD and Moderna announced that their joint investigational personalized mRNA cancer vaccine mRNA-4157/V940, in combination with Keytruda®, Merck’s anti-PD-1 therapy has been granted Priority Medicines (PRIME) scheme designation by the EMA for the adjuvant treatment of patie...

A Samsung Bioepis study published in JAMA Network Open has demonstrated that SB3, its proposed trastuzumab biosimilar is comparable to Genentech’s Herceptin®.   In their analysis of RCT outcomes of SB3 and Herceptin®, long term cardiac safety and efficacy were comparable af...

Accord BioPharma, the US speciality division of Intas, announced that the FDA has accepted its BLA for proposed trastuzumab biosimilar HLX02 for adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing me...

A study published in Frontiers in Pharmacology has found that the pharmacokinetic characteristics and immunogenicity of Livzon Mabpharm’s LZM008 were similar to Genentech’s ACTEMRA®.  The safety profiles of LZM008 were similar in two groups with mild–moderate adverse effect...

STADA announced the European launch of locally-manufactured Ximluci® (ranibizumab) biosimilar to Roche/Genentech’s Lucentis®.  Ximluci® is indicated for the treatment of visual impairment in all Lucentis® adult indications.

Ximluci® is the first product developed thr...

Sandoz announced that the EC granted marketing authorisation in the EU for its citrate-free high concentration (100mg/ml) formulation of its Hymiroz® (adalimumab), biosimilar to AbbVie’s Humira®, for all indicates covered by Humira®.

On 21 March 2023, the Sandoz citr...

Korea Biomedical Review reported that the 24 week results from Celltrion’s Ph III trials of CT-P42 (aflibercept) demonstrate equivalence and similarity to Regeneron’s Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regenero...

AstraZeneca announced that the CHMP has recommended marketing authorisation for its Ultomiris® (ravulizumab) to treat patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive.  If authorised, Ultomiris® would be the first and o...

The PBS Catch-up Statutory Price Reductions have reduced the cost of AbbVie’s Humira® products by 24.39% to $618.90, with adalimumab biosimilars (Arrow Pharma’s Hadlima®, Apotex’ Amgevita®, Sandoz’ Hyrimoz® and Fresenius Kabi’s Idacio®) reduced by 6.91%.  Interestingly, thi...