EC Approves Yesintek, a Stelara Biosimilar by Biocon, for Inflammatory Diseases

The European Commission (EC) has officially approved Yesintek, a biosimilar of ustekinumab created by Biocon Biologics, for the treatment of several inflammatory conditions. Yesintek is modeled after Johnson & Johnson’s medication Stelara. This approval allows Yesintek to be used in treating moderate-to-severe plaque psoriasis in both adults and children aged six and above, particularly for those whose condition has not improved with alternative systemic treatments or who are unable to use them.

Additionally, Yesintek has received approval for the treatment of active psoriatic arthritis in adults when disease-modifying anti-rheumatic drugs have not provided sufficient improvement. It can also be used for adults with moderately to severely active Crohn’s disease, especially in cases where other treatments have been ineffective or cannot be utilized.

As defined by the European Medicines Agency (EMA), a biosimilar is a type of biological medicine that closely resembles a product already sanctioned within the European Union. Consequently, patients can anticipate a level of safety and efficacy from the biosimilar equivalent to that offered by the reference product.

The EC’s decision regarding Yesintek is based on a recent endorsement from the EMA’s human medicines committee. The decision was further strengthened by clinical data that demonstrated Biocon’s Yesintek offers safety and effectiveness comparable to that of Stelara. According to the EU regulator, "The EMA determined that, in alignment with EU criteria for biosimilar medicines, Yesintek possesses a structure, purity, and biological activity that is highly similar to Stelara, and it is metabolized in the body in a similar fashion."

Globally, psoriasis affects at least 100 million individuals, representing an immune-mediated disorder that causes bodily inflammation. Plaque psoriasis, the most common form, affects up to 90% of patients with psoriasis and is marked by well-defined plaques usually covered by silvery scales. Psoriatic arthritis, often accompanying psoriasis, leads to joint pain, stiffness, and swelling, impacting approximately 30% of those with psoriasis.

Crohn’s disease, one of the principal types of inflammatory bowel disease, impacts around three million individuals in Europe. It manifests as chronic diarrhea and abdominal discomfort and can lead to complications necessitating hospitalization and surgical procedures if not managed adequately.

Ustekinumab, the active component in Yesintek, functions by inhibiting the activity of interleukin 12 and interleukin 23. These proteins are believed to play a crucial role in the inflammatory processes associated with psoriasis, psoriatic arthritis, and Crohn’s disease. By targeting these interleukins, the medication aims to reduce the inflammation and other symptoms linked with these persistent inflammatory conditions.