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Biosimilars are follow-on versions of biologic drugs and far more complex and more difficult to copy than generic drugs because of the structure of the molecule. “India offers a better opportunity for launbiosimilar drugs than other markets. In regulated markets we face challenge of proving biosimilarity, requirement of various quality standards and the plethora of patents that need to be looked at. Every regulator thinks biosimilars are different,” Patel said at the 13th edition of BioAsia in Hyderabad.
In the United States alone it is estimated biologic drugs worth $20 billion will go off patent in the coming years. Most of the drugs are widely prescribed for growing ailment of diseases like cancer. Patel said that most companies want to make the same biosimilar drugs, ignoring a whole range of other drugs.
“Biologic drugs are too expensive. We have to see how we can bring down the prices of these drugs. Also, our biosimilar industry is too nascent compared to pharma, so this will take time,” he said.
The comments come at a time when a few Indian drug makers such as Dr Reddy’s and Biocon are seeking to boost their biosimilar business in overseas markets. Dr Reddy’s in particular has been pumping up its pipeline by investing nearly $40 million in biosimilar research and development.
It has tied up with a number of global companies such as Germany’s Merck Serano to bring in a drug in regulated markets. In India the company sells nearly nine biosimilar drugs.
In India, too, generic drugs makers have been sporadic in their biosimilar launches. Partly because the price differentiation between the original drug and the biosimilars is not too much, these drugs have not managed to dent the market as a generic drug launch would do.
“The quantum of regulatory threshold required to launch a biosimilar drug might negate the size of the opportunity,” said Utkarsh Palnitkar, head-lifesciences at consultancy firm KPMG. “So you might require the same amount of threshold for a biosimilar that is required of an innovative drug, and that takes cost and time,” he said.
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