FDA approval puts India on the global map of biosimilars: Kiran Mazumdar-Shaw - (Forbes via NewsPoints Desk)

  • The recent approval of Biocon's Ogivri, marking the first approval of a biosimilar of Roche's Herceptin, could boost India's standing in the global market, Forbes reported Monday.

  • "India's pharma sector has played a pretty important global leadership role when it comes to generic drugs," remarked Biocon managing director Kiran Mazumdar-Shaw, adding "this category is based on our huge skill base in chemistry and synthetic chemistry. And we’ve leveraged that to take us to where we are today."

  • "Typically, a biosimilar drug can take upwards of $150 million to develop and about 80 percent of that cost is the clinical development price," Mazumdar-Shaw explained, continuing "the risk is pretty high because you are spending all this money and hoping that the data that comes out matches that from the tests conducted with the original drug."

  • "We have [the biologics] pegfilgrastim, [insulin glargine] and bevacizumab in our pipeline," the managing director disclosed, adding "I don't think there's a chance of huge competition in the first four to five years as there will be only a handful of players with the risk appetite and deep pockets to develop these kind of products."

  • "The fact that we started our biologics business with novel biologics gave us the confidence that we could address the biosimilars opportunity," stated Mazumdar-Shaw, continuing "we had the capabilities and understanding of large molecules which made it easier to make biosimilars. That said, Biocon's business strategy has always been about balancing biosimilars with novel biologics."

  • "Now we have embarked on developing a pipeline of interesting novel biologics, which we will look at as a global opportunity," noted Mazumdar-Shaw, adding "one is in the area of cancer again. These are called 'fusion antibodies'…and the method of action involves first attacking the tumour and then getting to the T-cells to further attack and kill the tumour."

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