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Jun 26, 2025
On 25 and 26 June 2025, respectively, Amgen filed BPCIA litigation in the US District Court for the District of New Jersey against Hikma Pharmaceuticals/Gedeon Richter and Shanghai Henlius Biotech/Organon…
Jun 25, 2025
On 25 June 2025, Bio-Thera Solutions, Ltd. and Costa Rican-based SteinCares announced that they have signed an agreement to commercialise biosimilar dupilumab across Latin America. Under the…
Jun 25, 2025
On 25 June 2025, Formycon announced that Klinge Biopharma, its exclusive global licensee of FYB203/Ahzantive®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2 mg), has entered an exclusive licence agreement with Valorum Biologics for commercialisation of FYB203 in the US and Canada…
Jun 24, 2025
On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating…
Jun 24, 2025
On 24 June 2025, Ono Pharmaceutical and BMS announced that they have received a supplemental approval for expanded use of Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in…
Jun 23, 2025
On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg)…
Jun 23, 2025
On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for…
Jun 23, 2025
On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®…
Jun 20, 2025
Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®)…
Jun 20, 2025
On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab)…
Jun 20, 2025
On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab…
Jun 19, 2025
On 19 June 2025, Australia’s Therapeutic Goods Administration (TGA) updated its online list of prescription medicine registrations to include expanded indications for BMS’ Opdivo® (nivolumab)…
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