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On 27 September 2024, the Australian Therapeutic Goods Administration (TGA) approved Pfizer’s Ixifi™, biosimilar to Janssen’s Remicade® (infliximab), in 100mg powder for injection vial for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, p...

On 27 September 2024, Formycon and Fresenius Kabi announced that Otulfi®/FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), has received approval from both the European Commission and the US FDA.  The European approval is for moderately to severely active Crohn’s disea...

On 27 September, AbbVie announced that it submitted a Biologics License Application (BLA) to the FDA for accelerated approval of telisotuzumab vedotin (Teliso-V) in adult patients with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR...

In a short decision published on 26 September 2024, Justice Meade of the High Court of Justice of England and Wales has refused Janssen leave to appeal from a decision that the UK counterpart of Janssen’s European Patent No. EP 3883606, relating to the use of ustekinumab fo...

On 25 September 2024, Eli Lilly published three-year data for its atopic dermatitis treatment, Ebglyss™ (lebrikizumab-lbkz).  The results, presented at the European Academy of Dermatology and Venereology (EADV), reportedly show that more than 80% of adults and adolescents w...

On 25 September 2024, MSD announced that Japan’s Ministry of Health, Labour and Welfare approved its Keytruda® (pembrolizumab) in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy, for patients with non-small cell lung carcinoma (NSCLC)...

On 25 September 2024, Biocon Biologics Ltd announced new data on its adalimumab and ustekinumab biosimilars, presented at the 2024 European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam.

The first set of data is results from a Phase 3 study comp...

On 25 September 2024, Alvotech announced commencement of a Phase 3 clinical trial for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), in moderate to severe ulcerative colitis.

In August 2024, Intas Pharmaceutical received approval from India’s Central Drug Stan...