Biocon Announces Exclusive Global Collaboration with Sandoz on Next-Generation Biosimilars
- What are the broad contours of the biosimilars co-development deal between Biocon and Sandoz?
This is an exclusive global collaboration between the two companies wherein both will share responsibility for end to end development, manufacturing and global regulatory approvals for a number of biosimilar products, and will have a cost and profit share arrangement globally. The collaboration will leverage the combined strengths of the two companies in development, manufacturing and commercialization of biosimilars.
- How many products will you be co-developing and for which therapy areas?
The collaboration aims to co-develop a set of identified high-quality, affordable immunology and oncology biologics, complementing our current biosimilars portfolio. It provides foundation for expansion of the portfolio.
- What are the financial terms of the deal?
Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products and will have a cost and profit share arrangement globally.
Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America, including the US and Canada, and EU, including European Free Trade Association and Balkan states, while Biocon will lead commercialization in Rest of the World, including India, Russia and Commonwealth of Independent States (CIS).
- What is the combined market potential of these multiple biosimilars?
The partnership will address a multi-billion dollar global opportunity.
- When do the patents expire for these products?
We are targeting opportunities that are expected to open up in the next decade.
- Will the development costs for these biosimilars start reflecting on Biocon’s P&L?
These biosimilars are in early stages of development. As the cost incurred during the early stages are not significant we don’t expect our R&D costs to go up materially as of now.
- What led Biocon to team up with Sandoz for developing these biosimilars?
Biocon is committed to provide affordable access to advanced biopharmaceuticals for global patient populations. We are developing advanced therapies that have the potential to benefit billions of patients, thus making healthcare both more effective and more equitable around the world. Along with Sandoz, we share a long-term commitment to increase patient access to high-quality biosimilars.
After successfully partnering Mylan, our collaboration with Sandoz is part of our journey of moving up the value chain. 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 commercializing them in the chosen geographies.
This collaboration is also in keeping with Biocon’s long-term strategy of targeting the global opportunity offered by the next wave of biosimilar products.
- What does the agreement with Sandoz mean for Biocon’s existing collaboration with Mylan?
The biosimilars being developed under the Biocon and Sandoz partnership is outside the portfolio being developed with Mylan and we are confident that this collaboration will be equally strong and meaningful in furthering our shared vision of expanding access to affordable biologics for patients globally.
Biocon and Mylan have one of the longest-standing partnerships in the global biosimilars space. We have leveraged our mutual strengths to build one of the largest and most diverse biosimilar pipelines, spanning biosimilar monoclonal antibodies, other recombinant proteins, and insulin analogs. We continue to work closely in advancing some of these products to be commercialized in various developed markets. We immensely value our partnership with Mylan and believe our joint portfolio will deliver near term value growth for us.
9.Are you aware if other global biosimilars players are also working on the same drugs that Biocon and Sandoz are collaborating on?
While we cannot comment on the pipelines of other companies, we believe there will be competition. However, given that biosimilars is a complex area with high entry barriers there will be a limited number of players, which makes it an attractive opportunity – and by beginning our work together now, we continue to be ahead of competition.
The article first appeared in MoneyControl on 19th January