On 1 July 2026, Australia’s Pharmaceutical Benefits Scheme published its Summary of Changes, which includes a newly PBS-listed ustekinumab biosimilar and new or expanded PBS-listings for a number of biopharmaceuticals.
The newly PBS-listed ustekinumab biosimilar is A...
On 1 July 2026, Celltrion announced that the FDA has granted interchangeability status to Truxima®, biosimilar to Genentech/Biogen’s Rituxan®, making it the first rituximab biosimilar in the US to earn this designation. As the first interchangeable rituximab biosimilar in ...
On 1 July 2026, Seoul Economic Daily reported that Celltrion has launched its new Omlyclo® (omalizumab) Pen Injection 150mg, an autoinjector formulation designed for the treatment of allergic asthma and chronic idiopathic urticaria.
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 26 June 2026 are set out below:<...
On 30 June 2026, EirGenix announced that it has signed an agreement for the licensing and commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab), in Japan. The partner to the deal has not been identified but is said to be a “leading Japanese pharmaceutic...
On 30 June 2026, Nordic-based Orion Pharma announced it has entered into an agreement with India-headquartered Shilpa Biologicals, a subsidiary of Shilpa Medicare, to commercialise in Europe Shilpa’s intravenous nivolumab biosimilar, which is currently under development.
Pearce IP continues to deliver on its commitment to set the standard for excellence in the provision of legal and intellectual property services across Australia and New Zealand wit...
On 29 June 2026, Health Canada approved Apotex’s Sevmia™, generic equivalent of Novo Nordisk’s Wegovy® (semaglutide). Sevmia™ is the first generic semaglutide product approved in Canada for chronic weight management.
Sevmia™ was developed in partnership with Orbicul...
On 29 June 2026, Samsung Bioepis announced positive results from global Phase 1 and Phase 3 clinical trials, confirming equivalence of SB27 (pembrolizumab) with the reference product, MSD’s Keytruda®. According to Samsung Bioepis, it is the first developer of a pembrolizum...
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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