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“Heal the World?” Perspectives from the recent Recovery XIV Conference

Unlike previous conferences, the Recovery of Biological Products XIV conference (Aug 1-6; Squaw Valley, CA) began with a forward-looking session preceding the opening keynote address that encouraged attendees to take a step back and look at the bigger picture before diving into a weeklong conference with very high-quality technical presentations and posters. In particular, three seemingly disparate presentations from the opening day defined a common theme of importance for the future of the biopharmaceutical industry.

 

Brian Kelley (Genentech) gave a well-articulated and constructed presentation, pointing out that the biotech industry has accumulated far more technological capability and production capacity to manufacture monoclonal antibody products (MAbs) than we are likely to need for the foreseeable future. By investing in both large-tank capacity (>20,000 L per batch) and process capabilities (volumetric productivities of >3 g/L), we have moved from batch sizes of 1-8 kg in 1997 when Rituxan was launched to batches of 50-100 kg today. With an installed base of bioreactor capacity approaching 3 million liters and growing, we could theoretically make well over 100 metric tons per year of antibody, far more than the estimated 7 metric tons required to meet the 2009 worldwide demand for all approved MAbs. Since we have succeeded well beyond the current needs of our business to produce MAbs at an acceptable cost of goods sold (COGS), reduction of COGS is not likely to be a driving force for new technology adoption in the foreseeable future. Given this, Brian posed some provocative and challenging questions around the need to invest in new technologies, strive for lower COGS, or even to build “Factories of the Future.” After the presentation, several participants asked equally provocative questions around the relative importance of reducing COGS in developed and emerging markets and the perils of technological stagnation that comes with standardization.

Cartikeya Reddy (Dr. Reddy’s Laboratories Ltd) next presented a very insightful overview of the biosimilar product development landscape, addressing two important tensions facing companies developing biosimilars. Specifically, these are the tension between regulatory frameworks and payer-prescriber-patient demands and requirements, and the tension between emerging markets and developed markets. Cartik’s talk highlighted the two fundamentally different approaches to developing biosimilars for emerging and developed markets. The enormous differences in the maturity of the regulatory framework and level of pharmacoeconomic control in the developed markets compared to emerging markets suggests that the time, effort, data requirements, and cost to navigate a biosimilar product through the regulatory approval process in developed markets will be significantly greater than in emerging markets and, more importantly, the cost of marketing and the resistance to adoption of new biosimilar products in developed markets will be far greater than in emerging markets.

As an illustration of this latter fact, Cartik provided some data on the dramatic price reduction in G-CSF and rituximab following approval of biosimilar versions of these products by Dr. Reddy’s Laboratories (DRL) in India. In both cases, the launch of DRL’s biosimilar product resulted in price reductions of 70-80% accompanied by 6-15 fold increases in unit volume sales compared to the innovator products prior to launch. This stands in stark contrast to the relatively low adoption rates of early biosimilars in developed markets, and the corresponding lack of price erosion.

Finally, Joseph Chamie (Center for Migration Studies), former director of the UN’s Population Division, gave a keynote address that provided a fascinating glimpse into the rapidly changing demographics of our planet as we head towards 9 billion people by 2100.With the world population and population distribution changing faster than at any time during recorded history, the implications for health care and for our industry are significant. For example, by the end of this century, the population of Africa will be almost 5 times that of Europe, a remarkable shift when you consider that Africa was far less populous than Europe 50 years ago. And did you know that in the coming years India will become the most populated country in the world? Or that one-third of the Italian population will soon be over 65?

A common theme emerging from these talks is the tension between the “haves” and the “have nots.” Brian reminded us that the driving force for technological innovation is pretty weak if you are already producing your products for a small fraction of their selling price and you’re sitting on half a million liters of underutilized capacity. This is especially interesting to consider when health organizations worldwide are struggling to control the ever increasing costs of prescription medicines. On the other hand, the world looks very different if you have no capacity and want to control the manufacturing of your product pipeline, particularly in emerging markets. Cartik pointed out this dilemma, noting the improbability of a single biosimilar development pathway that will work for both developed and emerging markets. These will be different for the simple reason that the needs and constraints in these two market segments are so dramatically different. And finally, Joseph Chamie reminded us that, for every person in the developed world who has access to the novel life-saving medicines that our industry produces, there are four or five people in lesser developed countries who don’t. And it is virtually certain that it will be many years, if ever, before full access to our products becomes a reality.

All of which connects these talks to BIO’s theme of “Heal the world; Fuel the world; Feed the world.” We should not lose sight of the incredible ability that our industry has collectively demonstrated to solve tough technical problems by bringing complex biopharmaceuticals to market in the first place and then dramatically lowering their cost of production over just a few decades. This should give us all hope in the power that our capacity for technical innovation and product development has to improve lives across the globe and – in the long run – to enable us to live more sustainably on our planet.

 

Blog article by Tom Ransohoff and Howard Levine