On 12 June 2025, Celltrion, Amgen and Pfizer each received FDA approval of an additional indication for their rituximab biosimilars (Truxima®, Riabni® and Ruxience®, respectively), for treatment of…
On 12 June 2025, the US FDA announced that it has approved MSD’s Keytruda® (pembrolizumab) for adults with resectable locally advanced head and neck squamous cell carcinoma (HNSCC) whose…
On 11 June 2025, Sweden-based Xbrane Biopharma and OneSource Specialty Pharma, an Indian-based CDMO, announced that they have entered a partnership for the commercial manufacture of Xbrane’s biosimilar portfolio…
On 10 June 2025, Outlook Therapeutics announced that the Scottish Medicines Consortium has accepted Lytenava™ (bevacizumab gamma) for use within NHS Scotland for the treatment of wet AMD…
On 9 June 2025, the Federal Court of Australia ordered that three Janssen Biotech innovation patents be revoked (AU2024100006, AU2024100007 and AU2024100016). The Court’s revocation…
On 9 June 2025, Samsung Bioepis announced that it has entered into a partnership agreement with NIPRO Corporation in Japan for multiple biosimilars, including SB17, Samsung Bioepis’ biosimilar to Janssen’s Stelara® (ustekinumab)…
On 9 June 2025, the US Patent Trial and Appeal Board issued a written decision invalidating all claims of Johns Hopkins University’s US Patent No. 11,591,393 on the basis of anticipation and obviousness…
On 9 June 2025, Celltrion announced that its Qoyvolma (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab) has received marketing approval from the European Commission (EC). Qoyvolma® is…
On 5 June 2025, Formycon announced that Brazil’s ANVISA has granted marketing authorisation for Ranivisio® (FYB201), biosimilar to Genentech’s Lucentis® (ranibizumab)…
On 5 June 2025, Alvotech and Dr Reddy’s announced that they have entered into a global collaboration and licence agreement to co-develop, manufacture and commercialise a biosimilar to MSD’s Keytruda® (pembrolizumab)…
On 4 June 2025, Sandoz Australia published a white paper entitled “Pioneering Access for Patients Through Biosimilar Medicines” which outlines proposals for reducing healthcare costs and expanding…
On 4 June 2025, Alvotech announced that it has completed the acquisition of Xbrane’s Swedish R&D operations, as well as XB003, biosimilar to UCB’s Cimzia® (certolizumab pegol), in a deal worth…
On 2 June 2025, Biocon announced that its generic liraglutide has been approved by India’s Central Drugs Standard Control Organisation (CDSCO) in 6 mg/ml solution for injection in pre-filled pen and…
On 2 June 2025, ChosunBiz reported that Celltrion has launched Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in Korea. Avtozma® was approved by Korea’s Ministry of Food and Drug Safety…
On 2 June 2025, Outlook Therapeutics announced that it has launched Lytenava™ (bevacizumab gamma) in the UK and Germany, for the treatment of nAMD. Lytenava™ is the first and only…
On 2 June 2025, Sandoz announced its US launch of Wyost® and Jubbonti®, biosimilars to Amgen’s Xgeva® and Prolia® (denosumab), respectively. Wyost® and Jubbonti® are the first and only…