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See the DrugPatentWatch profile for cimzia
Does Cimzia cross the placenta in the third trimester? Cimzia (certolizumab pegol) shows minimal placental transfer in the third trimester because its PEGylated structure limits active transport across the placenta. What levels reach the newborn? Infant blood levels at birth remain low or undetectable when the mother receives the drug late in pregnancy, unlike other TNF inhibitors that show higher fetal exposure. Why the difference from other biologics? Most monoclonal antibodies use Fc-mediated transport that increases sharply in the third trimester, but Cimzia lacks a functional Fc region, so this pathway is blocked. How do clinicians handle this? Some guidelines allow continuation through delivery when disease control outweighs theoretical risks, while others recommend stopping earlier; decisions rest on individual maternal disease activity. What about breastfeeding? Small amounts may appear in breast milk, but oral absorption by the infant is minimal, so exposure through nursing is considered low. When does patent protection end? Cimzia’s U.S. composition-of-matter patent expires in 2024, opening the possibility of biosimilar competition after that date.
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