It is more or less certain that Indian companies cannot repeat their relatively early success in chemical generics with biosimilars on the global stage. Indian biosimilars will sell – make no mistake. But it will likely be a whole bunch of large pharma and biotech companies like Merck, and Biogen selling them under their label.
Why do I think that? The costs of entering – and staying – in the biosimilars game are loaded against even our largest firms. You need trials that cost millions of dollars (where generics trials cost thousands). In the short term, you also probably need marketing and detailing expertise since governments do not mandate switching of a branded innovator drug by a biosimilar. Once there is sufficient experience with biosimilars to prove their safety, and efficacy this will likely change.
And you need patience and staying power- plenty of it – to deal with regulators who are keenly aware that if anything goes wrong it’s their neck on the line; they are taking their time figuring out how to get this right. The US biotech lobby, in a bid to protect its monopoly, has reinforced this fear by repeatedly pointing to the difference between chemical and biotech drugs. This also explains why the US, world’s largest pharma market, still has no regulatory pathway for biosimilars.
(Of course, I am assuming here that Indian companies can get their clones, expression systems, and scale-up right. That, by itself, is a substantial stumbling block.)
Emerging markets too appear to be treating this set of products differently. Here’s an excerpt from a recent interview that I conducted with G V Prasad, vice-chairman of Dr Reddy’s which makes a biosimilar of Genentech’s rituximab for cancer since 2007. Reddy’s Rituxan is currently available in India and international sales are expected to begin this fiscal.
Q : Is the registration process for a biosimilar slower even in emerging markets?
A: Biosimilar (approvals) are generally slower even in many emerging markets. Some of them (regulators) would need clinical trials, some may accept what we have done here (in India), some may want a much more analytical package. Biological molecules are not identical molecules so they will always have some differences so (you have to) explain those differences and ensure that those are not meaningful. Resolution and relevance both need to be done – resolution being analytical work, and relevance being clinical work
Q: So barriers to entry even in emerging markets exist.
A : And will probably get higher as the innovators influence the regulators.
But even if they did kickstart the emerging markets, companies with any strategic ambitions in biosimilars will need the US. That, I am assuming would have to be most large generics companies and also a clutch of innovators. After all, more and more new drugs are biologics and they will eventually lose patent protection.
Market analyst Datamonitor has come up with new research which suggests that without a biosimilars approval pathway in the US, the global opportunity to produce and market copies of biotech drugs appears far less attractive. In a statement released on June 23, the firm forecast that the US will account for 90 per cent of the volume of biosimilars sold in seven major markets by 2014. It expects biosimilars sales in these markets to cross a turnover of $2bn by then.
Datamonitor analyst Pam Narang says the “size of the US market combined with the voracious generic erosion that characterises it, makes it an attractive prospect for would-be biosimilars makers.” Besides, in the US “the balance of power” lies with the payer (such as insurers) rather than “physician-prescribing power and brand loyalty” which will facilitate a quicker uptake of relatively less expensive biosimilars, the agency believes. Germany and the UK are also expected to see greater biosimilars acceptance than say, Japan, France, Italy, and Spain where generics usage has been historically low.
To me what was more interesting was that the agency considers it a given that “large and established pharma companies are ideally positioned” to succeed in the biosimilars sector. It adds that “just which companies are selling biosimilars will have an impact on uptake across all markets, especially those are traditionally brand-loyal.” This is the reason why Merck and AstraZeneca are among those who have shown interest in the area, it feels.
What works for them, will likely work against Indian companies.
Datamonitor’s Narang expects that a pathway will be in place next year, but the first biosimilars launched only three years hence. Which makes me wonder how some companies are forecasting a launch over the next 12 to 24 months.
In the meantime, India needs new business models and ways to make its mark on the global biotech drugs scene.
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