Dive Brief:
- Novartis AG’s generics division Sandoz has inked a collaboration with Indian biosimilars developer Biocon Ltd. to develop biosimilars for immunology and oncology.
- The two companies will be equally responsible for end-to-end development, manufacturing and global regulatory approvals of an undisclosed number of biosimilars products.
- Sandoz will be responsible for commercialization of any products in North America and the EU, while Biocon will be responsible for commercialization in the rest of the world. No financial details were disclosed.
Dive Insight:
Biosimilar development has been a particularly hot area for biologic drugmakers over the last few years as we’ve seen the first several of these copycat drugs gain approval from the Food and Drug Administration. Despite the agency’s recent moves to support the approval of more generic and biosimilars drugs, few biosimilars have reached the market due to ongoing legal battles with the makers of the originating products.
Reports suggest that biosimilars could save the healthcare system as much as $150 billion over the next 10 years — but for these cost-saving estimates to be realized, biosimilars would have to actually enter the market, be at a significant discount to the reference products, and actually be used by patients.
Novartis’ Sandoz has set itself as an early leader in the space and has chosen a partner that is also considered an early entrant. Yet, most of the biosimilars that have been approved are of older TNF blockers that typically treat conditions like rheumatoid arthritis. A newer wave of biosimilars have been targeting oncologics.
Biocon and partner Mylan N.V. recently gained FDA approval for their copycat of Roche AG’s blockbuster cancer drug Herceptin (trastuzumab). Despite the approval, the partners reached an agreement with Roche to hold off on launching the biosimilars until an unspecified date.
"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,” said Richard Francis, CEO of Sandoz.