Biosimilars are expected to be a multibillion dollar market with the patent expiries of monoclonal antibodies. Although they are a reality in the last 5 years in certain parts of the world, expected FDA guidance for biosimilars is making the pie more interesting and this makes everybody to jump on this wagon throughout the world.
Not only the generic manufacturers like Sandoz, but also some innovators like Pfizer, Merck and GSK are already investing in biosimilars. Additionally, some giants from other industries like Samsung, Hanwha, Fujifilm Corporation have taken their places in this area already.
Hanwha, a South Korean chemicals company who is trying to develop the biosimilar version of Amgen/Pfizer’s Enbrel, made a recent deal with Merck Bioventures including the development and commercializing the product except South Korea and Turkey1.
HD 203 is a biosimilar version of the blockbuster treatment sold for rheumatoid arthritis, plaque psoriasis and ankylosing spondylitis. Its global sales hit a record of $3.27 billion last year.
Samsung, the electronics giant of South Korea, made a deal in February this year, with Quintiles Transnational Corp. for biosimilar development and biologicals manufacturing. The venture, with approximately $250 million in capital, will build a plant and the first target will be Roche/Genentech’s Mabthera/Rituxan. Rituxan sales was $6.1 billion last year and it was the world’s ninth best-selling product. Samsung has set the goal of generating US$1.8 trillion a year from biopharmaceuticals by 20202.
Additionally, in the recent years, we have also seen similar collaborations from other innovator giant companies like Pfizer, GSK and some others.
The cost of developing a typical biosimilar varies for different sources but it is around $100 million in general. The development period is longer than a small molecule generic but the possible income is making everybody excited in this area.
According to Reuters, there have already been nine deals for manufacturing, supply, distribution or licensing of biosimilars during 2011, compared to seven during the whole of 2010. As the prize is huge, the results should not surprise anyone who are interested in this area.