Aurobindo Pharma Limited announced that its step-down subsidiary, CuraTeQ Biologics s.r.o., has received marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for Dazublys™, a trastuzumab biosimilar.
This approval comes just a month after Dazublys™ was granted marketing authorisation in the European Union by the European Commission. The product is applyd primarily in the treatment of certain types of breast and gastric cancers, and its launch is expected to strengthen Aurobindo Pharma’s oncology portfolio in regulated markets.
According to the company, this is CuraTeQ’s fourth biosimilar approval by the UK regulator, following:
Notably, all three products are also approved in the European Union, underscoring the company’s expanding presence in the biosimilars market.
With this approval, Aurobindo Pharma continues to scale its biologics footprint, leveraging CuraTeQ’s pipeline to cater to oncology and critical care segments across Europe and the UK.
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