The ban on fixed dose combinations : Quick take #FDCban

I’ve been quite vocal in my views about the ban on fixed dose combinations on Twitter. So here’s a selection of my key tweets (and some retweets) on the subject. Good way to get a quick summary of the subject while I hem and haw over a longer article (if it ever gets written).  Latest tweets on top. Continue reading “The ban on fixed dose combinations : Quick take #FDCban”

Key takeaways from Cipla’s first biosimilar launch

On April 17, Cipla launched its first biosimilar drug in India. The product is Etacept, a branded biosimilar of Pfizer’s Enbrel (etanercept).

The drug treats rheumatoid arthritis (RA) an autoimmune disease that leads to painful and debilitating inflammation, predominantly of the joints, and is estimated to impact 0.7 per cent of the Indian population above the age of 16 years. Cipla imports the biosimilar from a Chinese company. While Cipla’s launch was muted – a quiet press release – the development is worth a closer look. Here are some key takeaways. Continue reading “Key takeaways from Cipla’s first biosimilar launch”

No Indian data on vaccines market?

At a recent press conference to announce the launch of its vaccine Prevenar 13, Pfizer MD Kewal Handa declined to share revenue numbers of the vaccine’s predecessor Prevenar in India. That’s not surprising – companies rarely reveal internal numbers for specific products. But what was surprising is that it did not provide ORG-IMS  numbers either. The reason the company cited: ORG-IMS audits are not set up to capture vaccines data especially since these are bought directly by doctors or hospitals from stockists. Hence, they said, it would not be accurate.

Now if companies won’t reveal their numbers, and the only available database in the country isn’t good enough then does this mean we will never know how big the private vaccines market in India is?  Vaccines after all are a high growth sector. Globally more money is going into vaccine research and development than before. And India’s baby cohort and growing middle-class mean that it’s a potentially large market for these companies. Surely there has to be a way?

Pfizer’s Nigerian nightmare. Or is it the other way around?

Children who participated in an allegedly botched Pfizer drug trial in Nigeria in 1996 may still have their day in an American court. The US Supreme Court has refused to block a suit brought against Pfizer by their families. The plaintiffs contend that Pfizer tested its experimental antibiotic Trovan during a meningitis epidemic in Nigeria without following due process of written informed consent. Nor did it warn the families of the drug’s side-effects or inform them that an approved drug was being distributed free by an aid organisation nearby. It also allegedly administered a low dose of a control (approved) antibiotic to make Trovan seem more efficacious.  Some children in the trial died while others suffered lasting damage. See here for details.

Pfizer – which has denied all wrongdoing – had insisted that the lawsuits should be filed in Nigeria not the US but the plaintiffs allege that Nigeria’s “corrupt” courts will not deliver justice. Pfizer has already paid the Nigerian government $75mn to settle claims.

This is a case that India should follow closely to its logical conclusion. To know why, look no further than Bhopal to see how good the country is at protecting its people. Now put that together with the pace of drug trials in the country and the absence of adequate oversight.