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On 27 December 2024, BMS announced that the US FDA has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20).  The approval cove...

On 27 December 2024, Celltrion announced that the US FDA has approved its Investigational New Drug (IND) application for a global Phase 3 clinical trial of CT-P44, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab).  According to Celltrion, the trial will involve...

On 26 December 2024, Hikma Pharmaceuticals announced that it has received FDA approval for, and launched, its generic version of Novo Nordisk’s Victoza® (liraglutide) in the US in a 6mg/mL dosage form.

The FDA prioritises review of generic versions of drugs that are ...

On 24 December 2024, Bio-Thera Solutions announced that it has entered an exclusive licensing agreement with Tabuk Pharmaceutical Manufacturing Company in relation to the commercialisation of BAT2206 (ustekinumab), biosimilar to J&J/Janssen’s Stelara®. Bio-Thera’s FDA B...

On 24 December 2024, Biocon announced that the company and its European partner, Zentiva, have received Decentralised Procedure (DCP) approval for liraglutide in the European Union.  The approval is for the generic versions of Novo Nordisk’s Victoza®, to treat type-2 diabet...

On 24 December 2024, GlycoNex announced that it has entered into a licensing agreement with an undisclosed partner for SPD8 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®.  Under the agreement, the licensee will be responsible for developing SPD8, securing regulatory...

On 23 December 2024, following the November 2024 recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult...

On 23 December 2024, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its Aptozma™/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), for all indications of Actemra®, including rheumatoid arthritis (RA), systemic juvenile idiopathic arthriti...

On 21 December 2024, Novo Nordisk announced that the US FDA has approved its Alhemo® (concizumab) injection as a once-daily prophylactic treatment to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years or age and older with haemoph...