Read our latest updates & insights

Bio-Thera Solutions announced that its phase III study of BAT2206 demonstrated it is highly similar to Janssen’s Stelara® (ustekinumab) in patients with moderate to severe plaque psoriasis.  Bio-Thera confirmed it will present the results at a future medical meeting or in a...

Samsung Biologics disclosed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has taken ₩3T (US$2.3B) in orders in 2023 after it has entered a new confidential sales/supply contract worth ₩588B (~US$457M).  The contract partner and contra...

Daiichi Sankyo announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare for Daichirona® for IV injection as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19.  Daichirona® is the first Japanese-made mRNA vaccine, and will...

Alvotech reported unaudited financial results for the first nine months of 2023.  Results included product revenue of US$29.8 million in 2023 compared to US$11.1 million for the same period in 2022, and R&D expenses of US$152.8 million compared to US$133.1 million in 20...

Biocon Biologics announced that it has completed the integration of Viatris in 31 countries in Europe.

Biocon Biologics completed the US integration in September 2023.  The multi-billion dollar deal was finalised in November 2022.

Formycon AG and Klinge Biopharma GmbH announced that they have applied to the European Medicines Agency (EMA) for marketing authorisation in the EU for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

Only a few days before on 24 November 2023, Celltrion annou...

Sanofi and Regeneron have announced they plan to file a supplemental biologics licence application (sBLA) with the FDA for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.  This application will be based on two phase III clinic...

Outlook Therapeutics announced that it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab, mark...

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing authorisation in the EU for its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) on 23 November 2023.  The application is based on the po...