Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 1 May 2026 are set out below:
CVS Health to Drop J&J’s Stelara® & Preference Biosimilar Ustekinumab
By Bioblast Editor | May 05, 2026
On 5 May 2026, Reuters reported that, from 1 July 2026, CVS Health will preference lower-cost, interchangeable biosimilars over Johnson & Johnson’s (J&J) Stelara® (ustekinumab) in its most common drug lists. CVS Health’s pharmacy benefit management unit, Caremark,...
FDA Approves Lannett/Sunshine Lake’s Interchangeable Biosimilar Insulin Glargine
By Bioblast Editor | May 04, 2026
On 4 May 2026, Lannett Company, with its wholly owned subsidiary, Lanexa Biologics, and Sunshine Lake Pharma (the pharmaceutical business arm of HEC Group) announced that the FDA has approved Langlara™ (insulin glargine-aldy), as an interchangeable biosimilar to Sanofi’s La...
New Indication Alert: FDA approves J&J’s Stelara® (Ustekinumab) for Paediatric Crohn’s Disease
By Bioblast Editor | May 01, 2026
On 1 May 2026, Janssen/Johnson & Johnson (J&J) announced that, on 15 April 2026, the FDA approved Stelara® (ustekinumab) for the treatment of children two years and older with moderately to severely active Crohn’s disease. Stelara® is now the only FDA-approved IL-1...
CuraTeQ’s Biosimilar Bevacizumab Approved in Canada
By Bioblast Editor | May 01, 2026
On 1 May 2026, Aurobindo announced that its subsidiary, CuraTeQ Biologics, received Canadian approval for Bevqolva™ (bevacizumab), biosimilar to Genentech’s Avastin®. Bevqolva™ is indicated for various cancers and is available in 100 mg and 400 mg formulations.
Cura...
Celltrion Submits EMA Application for Trastuzumab SC Biosimilar
By Bioblast Editor | Apr 30, 2026
On 30 April 2026, Celltrion announced that it had submitted an application to the European Medicines Agency (EMA) for Herzuma® SC/CT-P6 SC, biosimilar to Roche’s Herceptin® SC (trastuzumab hyaluronidase, marketed in the US as Herceptin Hylecta™).
The timing of the ap...
Xbrane Resubmits Ranibizumab Biosimilar BLA to FDA Following CRL
By Bioblast Editor | Apr 30, 2026
On 30 April 2026, Xbrane announced that it has resubmitted its BLA for biosimilar ranibizumab to the FDA following a Complete Response Letter (CRL) received in October 2025. In November 2025, Xbrane had indicated that it expected to resubmit its BLA in March 2026. However...
Inevitable Result and Clinical Trial Protocols
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 ...
Gedeon Richter’s Tocilizumab Biosimilar EU-Approved
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...
First Generic Ozempic® (Semaglutide) Approved in Canada for Dr Reddy’s & Apotex
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,...
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