My colleague Vikas Dandekar of Pharmasianews reports on a potentially pathbreaking event. Swiss drug maker Roche has struck a manufacturing deal with Pune's Emcure to produce some portion of its blockbuster biologic Herceptin for breast cancer and Pegasys for hepatitis B and C in India for India. Of course, it doesn't look as if Emcure … Continue reading Roche’s Emcure deal – thumbs up for market economics?
So finally the US Food and Drug Administration (FDA) has issued long-awaited draft guidelines for the approval of biosimilars or copycats of biologics that may not be identical to the original but similar enough on safety and efficacy parameters to be switched. See here. This is no humdrum development if you consider that billions of … Continue reading Biosimilars – Indian companies getting real?