Novartis and Biocon, which have each had success developing biosimilars on their own, will now see what they can do together. The two have formed a partnership to produce “next generation” biosimilars.
They announced the collaboration today saying they would share the costs equally for developing and commercializing multiple biosimilars in immunology and oncology. Sandoz, the generics unit of Novartis, will market them in the U.S., Canada and most of Europe, while India’s Biocon will take the rest of the world.
They said the partnership is an important part of their strategy to address the “next wave of biosimilar opportunities globally.”
“Together, we will be able to realize benefits at every stage of the value chain, from development, through manufacturing to commercialization," Carol Lynch, global head of biopharmaceuticals at Sandoz, said in a statement.
Both companies were early to biosimilars, with Novartis’ Zarxio, a copy of Amgen's blockbuster Neupogen, becoming the first biosimilar approved by the FDA. Last summer, Sandoz won EU approval for a biosimilar of Roche’s big-selling cancer drug Rituxan.
Biocon and its partner Mylan last month became the first drugmakers to win FDA approval of a biosimilar of Roche's blockbuster cancer drug Herceptin, a drug that raked in $2.5 billion in U.S. 2016 sales. It also has had success with insulin copies, winning a 2016 approval in Japan for its version of the world’s top-selling insulin, Sanofi’s Lantus.
But both companies have had their difficulties in the new realm as well. Biocon and Mylan had their progress with the Herceptin copy slowed by issues raised by both U.S. and EU regulators about a manufacturing facility in Bangalore. Changes made at the plant also led the FDA to issue a complete response letter for their proposed biosimilar pegfilgrastim, a copy of Amgen’s chemotherapy companion drug Neulasta.
Sandoz in 2016 also got a CRL for its version of Neulasta over questions raised about manufacturing and the biosimilarity of its product. Sandoz, working to erase the FDA’s concerns, last month released new data from a phase 1 study that the company said proves its version of the drug matches the original.
Novartis has indicated biosimilars are one bright spot in its generics business in the U.S. where tight pricing have made profits hard to come by. It is pushing forward with biosimilars even as it looks at downsizing or selling off some of its portfolio of small molecule drugs.