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The Scottish Medicines Consortium (SMC) accepted Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for restricted use within NHSScotland as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer when patients have received one or more pri...

The Korea Herald has reported that Celltrion has confirmed in a phase III study the safety and efficacy of CT-P39, a biosimilar to Genentech/Novartis’ Xolair® to treat asthma and urticaria.  The results indicate that CT-P39 prompted the same biological response in terms of ...

A study published in Clinical Ophthalmology has found that Intas’ Razumab® (ranibizumab) biosimilar to Genentech’s Lucentis® has similar efficacy and safety in Indian patients over 50 years old for treating neovascular age-related macular degeneration (nAMD).  The study pro...

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...