Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon, has received marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Yesintek, its biosimilar of ustekinumab.
This approval marks a significant step in Biocon Biologics’ expansion across major international markets, further strengthening its position in the global biosimilars landscape.
Yesintek is approved in the United Kingdom for use in both adult and pediatric populations. Its approved indications include:
These indications are aligned with those of the reference (originator) product, making Yesintek a viable, high-quality alternative for patients requiring long-term immunomodulatory treatment.
Biocon Biologics emphasized that clinical data from the ustekinumab biosimilar trial programme demonstrated comparable efficacy and safety to the originator product. This clinical similarity reinforces the biosimilar’s reliability and therapeutic equivalence in real-world medical settings.
In addition to the UK approval, the European Commission (EC) recently granted marketing authorization for ustekinumab biosimilar across all European Union (EU) member states and the European Economic Area (EEA). This pan-European approval opens new avenues for Biocon Biologics to supply its high-quality biosimilar therapies throughout the region.