The competition to tap large molecule structured complex bio-similars or off-patent biotech drugs (that are similar but not identical to reference or originator biological products) is heating up. Industry experts predict that by 2020, bio-similars could generate $290 billion revenue and account for 27 per cent of the pharmaceutical market. The highest demand is for bio-similars for cancer and cardiovascular diseases. These are complex, difficult to make and need massive investments, unlike conventional chemically derived pharmaceutical drugs. What's more, the chances of failure are high.
The prohibitive cost of developing these drugs and clearing separate benchmarks for different countries has, meanwhile, made many Indian players partner with firms abroad to cover research costs. Recently, Lupin tied up with Japanese firm Yoshindo for a rheumatoid arthritis drug, a bio-similar for Etanercept of Pfizer/Amgen with a $12 billion opportunity globally.
By P.B. Jayakumar