On 19 June 2025, the Unified Patent Court (UPC) Court of Appeal issued decisions refusing two rehearing applications by Alexion Pharmaceuticals in proceedings it had brought seeking preliminary…
On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicines for evaluation for March, April and May 2025…
On 17 June 2025, Regeneron filed a new BPCIA complaint against Amgen in the United States District Court for the Central District of California, asserting that Amgen’s Pavblu™/ABP 938 (aflibercept)…
On 16 June 2025, Celltrion announced that the FDA has approved a new single-dose 45mg/0.5mL subcutaneous injection of Steqeyma® (CT-P43), biosimilar to J&J/Janssen’s Stelara® (ustekinumab)…
On 16 June 2025, Korea Biomedical Review reported that the Dusseldorf Higher Regional Court ruled that Samsung Bioepis/Biogen’s Imraldi®, biosimilar to AbbVie’s Humira® (adalimumab), infringes a formulation patent held in Germany by Fresenius Kabi…
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…