The agreement announced this week will see Novartis subsidiary Sandoz share the development and production of an undisclosed number of third wave biosimilar candidates with Indian biomanufacturer Biocon.
“The biosimilar assets that are part of this agreement complement our existing portfolio in immunology and oncology,” Sandoz spokesperson Chris Lewis told Biopharma-Reporter. “Because they are all still at a fairly early stage of development, we would make further disclosures at appropriate development and commercial milestones.”
First wave products are generally versions of cytokines, growth factors and hormones already off patent. This includes Amgen’s Neupogen (pegfilgrastim) which is seeing competition from Sandoz’s Zarxio/Zarzio.
Second wave biosimilars are generally monoclonal antibodies which come off patent before 2020, for example Sandoz’s US approved Erelzi (etanercept).
Third wave biosimilars are versions of more complex mAbs or antibody fragment drugs coming off patent after 2020. Sandoz has yet to reveal any such candidate in its pipeline, but potential targets would be versions of Regeneron’s Eylea (aflibercept) or J&J’s Stelara (ustekinumab).
Sandoz claims to be the only company to have five successful biosimilars across various markets, including its version of AbbVie’s Humira (adalimumab) submitted for US FDA review this week. And this deal aims to replenish its biosimilar pipeline with “next generation,” or third wave, products to remain a major biosimilar competitor in the future.
“The collaboration positions Sandoz to continue its biosimilar leadership well into the next decade, building on five marketed biosimilars and our capabilities in development, manufacturing and commercialisation,” said Lewis.
Under terms of the deal, Sandoz will commercialise any products in North America and the EU, while Biocon will lead commercialization in other territories.
Up the value curve
Biocon is already present in the biosimilar space through its collaboration with Mylan, and the two firms recently saw their version of Roche’s Herceptin, Ogivri, become the first trastuzumab biosimilar to win approval in the US.
“This synergistic partnership will enable us to move up the value curve and also scale up our capabilities for an ‘end to end’ play in the global biosimilars space to address the next wave of opportunities,” a spokesperson from the firm told us.
The spokesperson confirmed biosimilars developed with Sandoz are outside the portfolio being developed with Mylan, and added this partnership was the next step in “moving up the value chain” for the Bangalore-headquartered firm.
“In this partnership, Biocon will get an opportunity to participate not only in end to end development and manufacturing of the partnered products but also in obtaining regulatory approvals and commercialising them in the chosen geographies.”