A ‘Toxin’ Delaying Success of Biosimilar Drugs

The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important … Continue reading

‘Rigged’ Payment System Limits Biosimilar Access

As often discussed, market entry of biosimilars, in general, brings a new hope not just for many patients, but also to biosimilar drug manufacturers – planning to get marketing approvals of these drugs in the United States, the El Dorado … Continue reading

Drugs From The Same Indian Plant: Safe For Europe, Unsafe For America, Why?

Good number of stories on US-FDA banning several drug manufacturing facilities of major domestic players of India over serious quality related issues, have been doing the rounds since about a year and almost at a regular interval. The quagmire has … Continue reading

Does India Believe in Two Different Drug Quality standards?

“Maintain and sharpen your intellectual honesty so that you’re always realistic. See things as they are, not way you want them to be.” The above profound statement is what the Management Guru Ram Charan made in his book titled, ‘Execution: … Continue reading

Threats to Indian Generics: Failing in US Inspections is Just Half The Story

At a recent event of the American Enterprise Institute, Dr. Harry Lever, a senior cardiologist at the Cleveland Clinic in Ohio, reportedly expressed his concern based on his personal experience regarding inconsistent quality among Indian generics. As a result, he requires switching patients … Continue reading