On 29 April 2026, Gedeon Richter announced that the European Commission has granted marketing authorisation for Tuyory ®, biosimilar to Roche’s RoActemra® (tocilizumab). This follows a positive opinion for Tuyory® in February 2026 from the European Medicine Agency’s Commit...
Following the March 2026 launch of several generic equivalents of Novo Nordisk’s Ozempic® (semaglutide) in India and the “tentative approval” of Apotex’s generic semaglutide in the US, the first semaglutide generics have now been approved in Canada.
On 29 April 2026, the European Commission approved Shanghai Henlius and Organon’s Poherdy® (pertuzumab) as the first biosimilar to Genentech/Roche’s Perjeta®.
Poherdy® is indicated for use (with trastuzumab and docetaxel) in adults with HER2-positive metastatic or lo...
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 24 April 2026 are set out below:...
On 28 April 2026, Celltrion announced the launch of Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in Japan. Avtozma® is the first tocilizumab biosimilar to be launched in Japan, having also been the first to receive approval in September 2025.
At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:
Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syr...
On 27 April 2026, Jazz Pharmaceuticals announced that the FDA accepted for priority review a supplemental Biologics License Application (sBLA) for Ziihera® (zanidatamab-hrii) in combination with BeOne’s (formerly BeiGene’s) Tevimbra® (tislelizumab) and chemotherapy for the ...
On 27 April 2026, Samsung Bioepis published its 13th US Biosimilar Market Report, which has been released every quarter since April 2023. The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (WAC) ...
On 27 April 2026, Sun Pharmaceutical Industries Limited and Organon & Co announced that they have entered into a definitive agreement for the acquisition by Sun Pharma of all outstanding shares of Organon in an all-cash transaction valued at US$11.75 billion.
CEO and Founder Naomi Pearce has been recommended in the Lexology Index – Healthcare & Life Sciences 2026, with recognition in the highly competitive Patent Litigation cat...
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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