On 12 March 2025, Medical Dialogues reported that Intas Pharmaceuticals has received approval from India’s Subject Expert Committee functional under the Central Drug Standard Control Organisation (CDSCO) to conduct Phase 2/3 trials of bevacizumab (solution for intravitreal ...
On 11 March 2025, Celltrion announced that its biosimilar infliximab for injection, currently known as Inflectra®, will be rebranded to Remdantry™ in Canada commencing on 1 April 2025. The formulation, indications and dosages of Remdantry™ will remain the same as those for...
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 7 March 2025 are set out below:...
On 10 March 2025, Coherus BioSciences reported its fourth quarter and full year financial results for 2024, and announced that it will transfer approximately 50 employees to Intas Pharmaceuticals’ specialty unit, Accord BioPharma. The move will reduce Coherus’ workforce by...
On 9 March 2025, Sun Pharma and Checkpoint Therapeutics announced that they have entered into an agreement for Sun Pharma to acquire Checkpoint Therapeutics. Under the deal, Sun Pharma will own Checkpoint’s leading biopharmaceutical Unloxcyt™ (cosibelimab).
On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic plaque psoriasis (PsO). The study reportedly demonstrated equivalent efficacy, ...
On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab). Omlyclo® is approved as a 75 mg/0.5ml and 150mg/ml injection in a single pre-filled syringe for subcuta...
On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with unresectable or advanced hepatocellular carcinoma (HCC). The EC approval follows the CH...
On 7 March 2025, AstraZeneca announced that India’s Central Drugs Standard Control Organisation (CDSCO) has approved its Imfinzi® (durvalumab) 120 mg/2.4 mL and 500 mg/10 mL solution for infusion, for the treatment of patients with limited-stage small cell lung cancer (LS-S...
On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi in relation to its denosumab biosimilar. The order followed a stipulation by t...
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