Biosimilars
Manufacturing processes for biologics differ greatly from the small molecules. Small molecules therapeutics is synthesized using chemical reactions. Biologics, by comparison, are produced within engineered cells. Small molecules are well characterized, and can be easily purified and analyzed with routine laboratory tests. Biologics tend to be produced as diverse mixtures of molecules that differ although very slightly from one another, which make it difficult to characterize. The properties of biologics often depend on the nature of the manufacturing process. Furthermore, proteins have unique structural organization patterns (referred to as "folding") that affect the way that they work in the body; even biologics that are chemically the same may have different biological effects due to differences in its structural folding. An example is the difference between a raw egg and a cooked one, chemically the two are the same, but they are physically and biologically different.
Why Biosimilars?
Biologic drugs are:
• Effective clinically
• Successful in revenue generation
• Daily therapy costs X22 small molecule costs in the US, top six biologics = 43%of US Medicare B drug costs.
Why now?
• Demand by patients and care givers for competition to reduce prices
• Vast patent expiry in recent and up coming years, an estimated 40% in global biologics sales will be off patent by 2015
• Increase demand in the developing countries for modern biologics
• Biosimilars are recognized around the world as safe and effective medicines
• Approved regulatory pathway by the EMEA and recently initiated by the US FDA
Challenges to overcome with the help of Vanir Bio PTE:
• Significant time, resources and expertise required for developing biosimilars
• Need access to cost efficient and high quality manufacturing capacity and expertise
• Sourcing a “highly similar” drug product to innovator is complex and requires vast knowledge and experience.
• No ICH like global regulatory harmony yet
