21 September 2018 - Positive opinion is based on comprehensive data confirming that Sandoz biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.
Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the CHMP of the EMA has adopted a positive opinion for marketing authorisation of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim.
Sandoz is committed to increasing patient access to high-quality biosimilars, with five marketed and seven approved biosimilars in Europe.