Guest column : The ‘sin’ that led to an #FDA inspection #pharma #quality

Ajit KamathYou can imagine the trepidation of a pharmaceutical company when the US Food & Drug Administration (FDA) comes calling. Given the demanding nature of inspections, recent enforcement actions and the public scrutiny that each warning letter is subjected to, even a battle-ready manufacturing site with the most stouthearted management can’t help but feel a ripple of nervous tension.

Now, consider the situation if the visit were wholly unexpected. Continue reading “Guest column : The ‘sin’ that led to an #FDA inspection #pharma #quality”

India #Pharma 2014 : A quick look back – Part One #quality

The holiday season approaches, so here’s a quick look at the year that was for Indian Pharma, before we disappear into a haze of year-end festivities. It’s a mixed bag (what year isn’t?) including stuff that could influence the way things work in the years ahead. For convenience, I’ve divided up what I think are key developments into posts rather than stick to any specific chronology of events. In the first post, I look at developments in the regulation of Indian manufacturing. Continue reading “India #Pharma 2014 : A quick look back – Part One #quality”

Biosimilars – Indian companies getting real?

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 dollars worth of biologics are losing patent protection in the US in the coming years.

Yet Indian companies have not exactly been falling over each other hailing the move and making bullish predictions. The guidelines came out around the time of an Indian biotechnology industry conference in Hyderabad.  I could find no reporting on reactions to the guidelines from there.

There are two very credible reasons for this. One, industry is still poring over the details – which is where the devil usually lurks. And two,  one senior drug industry executive informed me that the US FDA has been open to providing advice since 2010 when the Biologics Price Competition and Innovation Act of 2009 was made into law to encouarage cheaper biosimilars as a way to bring down ballooning healthcare costs.  So in that sense, this is not exactly a watershed moment.

Yet, I’d like to think that at least some of the silence  suggests that Indian companies acknowledge and accept that hawking biosimilars to advanced markets is going to be a really long haul. And that this is one of many baby step to getting there.

How long? Well,  biologics began losing patent protection in western markets in the early 200s.  But the EU began approving biosimilars only in 2006. There’s still no India biosimilar in Europe.  It is now 2012 and the US has issued draft guidelines which are yet not final. In any event, the tests needed to prove biosimilarity are far more elaborate and their results a lot less certain than in the case of vanilla generics.

In such a situation it has become extremely difficult to predict with certainty when, if at all, an Indian biosimilar will launch either in the US or EU.

Being low-key has its advantages.  This approach sets no expectations among investors and other observers. Anything good that follows is a bonus.