An additional lead pipeline candidate is being developed in partnership with Polpharma Biologics. PB006 is our second most advanced biosimilar candidate and belongs to the third-wave biosimilars. We have completed PB006 process development and reached an important milestone in taking PB006 into GMP production.
Pre-clinical studies were completed successfully and human bioequivalence studies are scheduled for early 2018. Clinical development and all regulatory activities are conducted by bioeq. Market launch of the PB006 biosimilar is anticipated in 2021.