Big Molecule Watch
November 11, 2016

CHMP Recommends Approval of Three Biosimilars to EMA

The Committee for Medicinal Products for Human Use, (“CHMP”), the committee at the European Medicines Agency (“EMA”) that is responsible for preparing opinions on questions concerning medicines for human use met earlier this week and recommended approval of nine medicines to the EMA.  Of the nine medicines recommended for approval, three are biosimilars: (1) Lusduna™ (insulin glargine), Merck Sharpe and Dohme’s biosimilar to Sanofi’s Lantus® for the treatment of diabetes; (2) Movymia (teriparatide), STADA Arzneimittle AG’s biosimilar to Lilly’s Forteo® for the treatment of osteoporosis; and (3) Terrosa (teriparatide), Gideon Richter plc’s biosimilar to Forteo®.

The CHMP’s opinion is a step in the regulatory pathway towards a grant of market authorization by the EMA.