What are the risks of using cosentyx while breastfeeding?

What are the risks of using Cosentyx while breastfeeding?

Cosentyx contains secukinumab, a monoclonal antibody that targets interleukin-17A. Because antibodies can pass into breast milk, doctors generally advise against using Cosentyx during breastfeeding.

How does secukinumab reach breast milk?

Secukinumab is a large protein molecule. Large proteins have low oral bioavailability, which means a nursing infant would absorb only a small fraction of any amount that enters breast milk. Still, potential effects on the infant's immune system remain a concern because secukinumab suppresses immune responses.

What clinical data exist on secukinumab in lactation?

Limited human data guide decisions. One case report describes a woman who continued secukinumab throughout pregnancy and lactation. The infant showed no immediate adverse effects, but this is single-case evidence. No large-scale studies track long-term outcomes for breastfed infants exposed to secukinumab.

Why are companies challenging this patent?

Secukinumab is covered by several U.S. patents held by Novartis. Multiple biosimilar developers have filed petitions at the Patent Trial and Appeal Board to invalidate key patents. Some petitions have succeeded in canceling claims, which could accelerate biosimilar entry.

When does patent expire?

The basic composition-of-matter patent for secukinumab expires in 2031. Extended exclusivity periods, including pediatric and orphan-drug extensions, may push full generic or biosimilar competition to 2032 or later.