Teva Secures FDA Nod For PONLIMSI, Biosimilar Candidate To Xolair Applications Accepted By FDA & EMA

The FDA approved PONLIMSI, Teva's biosimilar to Prolia, the company announced, clearing the way to market a denosumab biosimilar for osteoporosis and other bone conditions in the U.S. Approval strengthens Teva’s biologics/generics franchise and could incrementally boost specialty revenue while increasing competitive pressure on the Prolia incumbent. The news is likely to be modestly positive for Teva shares, with potential low single-digit percent moves for the stock and clearer revenue upside as commercialization details and pricing emerge.

Analysis

The FDA approved PONLIMSI, Teva's biosimilar to Prolia, the company announced, clearing the way to market a denosumab biosimilar for osteoporosis and other bone conditions in the U.S. Approval strengthens Teva’s biologics/generics franchise and could incrementally boost specialty revenue while increasing competitive pressure on the Prolia incumbent. The news is likely to be modestly positive for Teva shares, with potential low single-digit percent moves for the stock and clearer revenue upside as commercialization details and pricing emerge.