Novartis division Sandoz has teamed with Polpharma for the commercialization rights to a Phase III biosimilar of Biogen’s multiple sclerosis monoclonal antibody Tysabri (natalizumab).
The deal sees Sandoz enter into an agreement with Polpharma Biologics to commercialize and distribute worldwide the Polish biopharma firm’s natalizumab program, currently in Phase III trials. The molecule is being developed as a biosimilar of the relapsing-remitting multiple sclerosis (RRMS) monoclonal antibody Tysabri, which pulled in $1.86 billion (€1.7 billion) for Biogen in 2018.
“Polpharma Biologics will maintain responsibility for development, manufacturing and supply,” Sandoz spokesman Chris Lewis told Bioprocess Insider.
While he would not comment on manufacturing location or plans for scale-up, Polpharma has cGMP facilities in Central Europe, specifically one in Gdańsk, Poland and another in Duchnice, Poland which will be run by Polpharma Biologics’ CMO partner when operational next year.
Sandoz itself has been one of the leading companies in the biosimilar space, with eight products approved and launched in various markets. This includes Zarxio (filgrastim), the first biosimilar to be approved and launched in the US.
The firm is also developing a pegfilgrastim and denosumab biosimilar in-house, along with having various development partnerships in place. These include Gan & Lee, EirGenix, Biocon, and now Polpharma.
“To achieve our goal of remaining a global leader in biosimilars for the long term, we need a broad portfolio to match our extensive commercial footprint,” said Lewis.
“Collaborations such as this allow us to commercialize more biosimilars than we could on our own and focus internal resources on other priorities.”