Biocon, Sandoz to Partner on Next Wave of Biosimilars

Biosimilar developer Sandoz announced today that it has entered into a global partnership with India-based Biocon to develop, manufacture, and commercialize multiple biosimilars targeting immunology and oncology indications.

Under the agreement, the companies will share responsibility for end-to-end development, manufacturing, and regulatory approvals for the products in question, and will share costs and profits. Sandoz will lead commercialization of approved biosimilars in North America and the European Union, while Biocon will commercialize the drugs in the rest of the world.

“Today’s announcement bolsters our leadership position in biosimilars and positions us to continue to lead well into the future,” said Richard Francis, CEO of Sandoz, in a statement. “Biocon is a great complement to our proven biosimilar capabilities at Sandoz. Through this collaboration, we are reinforcing our long-term commitment to increase patient access to biologics.”

Chairperson and managing director of Biocon, Kiran Mazumdar-Shaw, added, “This synergistic partnership will enable us to scale up our capabilities for an end-to-end play in the global biosimilars space.”

The agreement with Sandoz forms Biocon’s second partnership seeking to bring its biosimilars to the US and EU markets; Biocon successfully partnered with Mylan on a trastuzumab biosimilar, Ogivri, approved by the FDA in December 2017. Last week, at the 36th Annual J.P. Morgan Healthcare Conference, Rajiv Malik, company president of Mylan, hinted that Biocon—Mylan’s pegfilgrastim biosimilar could gain FDA approval by the middle of 2018. Both the trastuzumab and pegfilgrastim products are also under European regulatory review.

News of the Sandoz—Biocon partnership comes just days after Sandoz announced that the FDA has accepted for review its Biologics License Application (BLA) for a proposed adalimumab (Humira) biosimilar. The drug maker has already received FDA’s nod for its etanercept biosimilar (which will be marketed in the United States as Erelzi, though no launch date has been made public) and its filgrastim biosimilar (Zarxio). The FDA is currently considering a BLA for Sandoz’s rituximab biosimilar, and the drug maker reports that it will refile its BLA for a pegfilgrastim biosimilar in 2019.