For generic dug manufacturers in India and elsewhere the number of blockbuster drugs that have recently come off patent has been a bonanza. But the product mix coming off patent over the next three years is dramatically different to the small molecule blockbuster drugs that dominated patent expirations in 2012. This presents a problem for … Continue reading Guest column : Can Indian generics move from blockbusters to biologics?
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?