Grunenthal GmbH [2026] APO 9 (16 March 2026)
Date of decision:
16 March 2026
Body:
Australian Patent Office
Adjudicator:
Dr ...
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By Naomi Pearce, Helen Macpherson, Mathew Lucas PhD | Apr 30, 2026
Grunenthal GmbH [2026] APO 9 (16 March 2026)
Date of decision:
16 March 2026
Body:
Australian Patent Office
Adjudicator:
Dr ...
By Bioblast Editor | Apr 29, 2026
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...
By Bioblast Editor | Apr 29, 2026
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,...
By Bioblast Editor | Apr 29, 2026
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...
By Naomi Pearce, Chantal Savage, Maliha Hoque | Apr 29, 2026
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:...
By Bioblast Editor | Apr 28, 2026
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.
Avtoz...
By Bioblast Editor | Apr 28, 2026
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...
By Bioblast Editor | Apr 27, 2026
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 ...
By Bioblast Editor | Apr 27, 2026
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) ...
By Bioblast Editor | Apr 27, 2026
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.
The...
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