Comrades!
I come to you live from the sixth annual Moscow International Congress on Biotechnology, where I have just given my presentation titled, “Biosimilars: Safety or Savings?”
Here is a sampler:
The age of the blockbuster is over. Cost concerns are more challenging than ever. And we are struggling with what “personalized medicine” really means.
We are now in the era of post-patent medicine where advances in manufacturing and molecular diagnostics are as important as new molecular entities, and safety is as important (and as improvable) as efficacy.
The era of post-patent medicine is also the epoch of biosimilars. But will biosimilars really be as important an element of change as many believe. Will it be, as we like to say in the United States, a game changer?
I believe the answer is “yes,” but I am not sure whether or not all the changes will positively affect the advancement of the public health. I fear the expectations that biosimilars will radically reduce costs are overstated. I fear that safety concerns are being understated and that the risks to innovation are real.
As Eli Lilly & Co. CEO John Leichleiter said, "Creating and maintaining the conditions for innovation to flourish is challenging and complicated work - work that is never finished.”
What is the place for Russia in all this? Russia will certainly offer an attractive market for biosimilars and biobetters. With millions of people, and tremendous unmet medical need, we can expect the uptake of quality biosimilar and biobetter products to be substantial, particularly if those products are available at a substantial cost savings, or offer additional therapeutic benefits.
But beyond the market potential, what about the role of Russia as a center for biosimilar and biobetter research and manufacture?
I believe that Russia’s strong tradition in science and medicine offers a platform to both develop and produce these medicines – and potentially not only for its domestic market, but also for export.
Such a proposition is not without risks and it will be a complicated decision depending on a variety of local factors. One critical element will be an evolving regulatory framework.
To protect the health and safety of Russian patients and, moreover, if Russia hopes to export these medicines, a 21st century, state of the art, internationally recognized and harmonized regulatory system will be a fundamental requirement.
No patient, whether in the USA, Europe or Russia, should be exposed to low quality, unreliable biosimilars or unproven biobetters. And no payor -- whether private or government -- should spend one kopek on uncertain products.
I understand that the Russian Health Ministry is looking at revising Russia’s biosimilar regulations to meet the highest international standards and I can think of few things that would be more in the interest of Russian patients or more firmly guarantee Russia’s investments and economic aspirations in this area.
Simply put, a good regulatory system is good for the public health and good for business.
There’s much more to share from my mission to Moscow (which runs through the end of this week). Stay tuned as I delve further into the state of healthcare in Russia – truly a riddle wrapped in a mystery inside an enigma.
