United Laboratories International Holdings Limited (“TUL”), a leading pharmaceutical company in the People’s Republic of China (PRC), has received official production approval for all three recombinant human insulin products: Rapid Acting (Humulin R), Long Acting (Humulin N) and Intermediate Acting (NPH). The release states:
“TUL spent 8 years on research and development of the recombinant human insulin products. Afterwards, the Group invited the assessment organizations recognized by the Government to carry out clinical treatment tests and assessment exercises. Results show that the equivalent treatment effectiveness of the new product is equivalent to that of the imported insulin series. The products are mainly used for clinical treatment of type 1 and type 2 diabetes. […] Currently, China’s diabetes patients are more than 100 million. The demand for recombinant human insulin products in China is about 6 billion RMB per year. “ (Nearly 1 billion US $ per year).
“With [a] well-established sales force, network and strategies, the [TUL] Group foresees a new era driven by the insulin products. We are now conducting research on insulin analogues such as insulin glargine (Lantus) and insulin aspart (NovoRapid). We hope that we can launch these two products to market next year.”
Even though production has not been approved for the analogue (ie, glargine, lispro, aspart — so-called designer insulins), they are evidently in development. My guess is TUL will not be the only Chinese pharmaceutical utilizing R&D for insulin production. Whatever the case, this is big news for our friends over at Lilly, Novo Nordisk and Sanofi-Aventis. This news is especially rattling for Lilly and Novo Nordisk who are more dependent on sales of their branded insulin for survival in the global market. Has a new era begun? The PRC would certainly be foolish, given their robust stand on trade regulations to allow foreign pharmaceuticals to benefit from a percentage of the 100 million diabetics in China who require or who will require insulin. Given the diabetes epidemic in Asia, particularly in China – a wave of new entries to the market is inevitable.
I live in Hong Kong and along with other patients using analogues here and on the mainland, I must source NovoRapid (produced by the Danish Company, Novo Nordisk), which has been manufactured nearby in a plant in China. Lilly’s Humalog is also available to me. When I was growing up with Type 1 in the 1970s and 80s, Lilly insulin was a brand as recognizable as Colgate Toothpaste or Ivory Soap. That changed when my New York endocrinologist suggested I switch to European brand Novo Nordisk even though I had been faithfully injecting Lilly’s Humalog (Lispro). I was stunned at first; how could I switch to another brand after starting out with and using evolving compounds of Lilly since I was diagnosed as a kid? Lilly products had worked on saving my life for years. This switch wasn’t like changing one aspirin for another, I depended on my brand of insulin to stay alive, not just feel better. So, it was with some anxiety that I made the switch. Did I ever feel disloyal when I made the change? Not much, I was more concerned about efficacy. Everything worked out in the end, but I was shocked to understand that insulin prices did not decrease, not even in a competitive market. When Sanofi-Aventis launched Lantus in 2000, I realized that the most effective insulins were not intended to be affordable for patients. Where were the generics? Even though analogues were a far cry from what Banting and Best had discovered in the early 1920s, what made the newer insulins so precious and so hard to replicate? Patents, politics, and profits. The three P’s – a financial hard-ship recipe for the chronically ill doomed to lifelong existence on branded prescriptions.
Here in Asia, progress in diabetes care is moving forward, but there is a perception of less to zero credibility in best practice and standards (let’s call it quality control) for Western consumers. I see it another way. Given the FDA’s recent record(Does the FDA have a Drug Problem?) for mishaps and fatalities, why do US consumers continue to have blind faith in pharmaceutical regulations? The European Union is much tougher on standards when compared to the US, but debt challenges abound these days in the EU and may affect public health. Companies such as Novo Nordisk, Lilly and other leaders in Big Pharma are turning to Asia for expansion. Regarding standards of manufacturing practices, aren’t they all relying on the same regulations and workforce in China? Time will tell, but the playing field is at the very least, starting to level out. China is determined to ensure that science and academia have equivalent prestige and respect as counterparts in the West, and a similar determination and need exists when it comes to replicating Western technology — which applies to medicine too. Is United Labs (TUL) planning on marketing their insulin as a generic? Probably not, but China’s state run health care system will always deliver the lowest cost insulin in demand to hospitals across all provinces and if United Labs is successful, something tells me the PRC will buy local.
Unsurprisingly, China’s not the only Asian insulin manufacturer. India and Pakistan have been leaders for years – manufacturing animal, human and analogue insulin for local SE Asian markets. India’s Biocon, Wockhardt and Middle East/Pakistan’s Getz have been working hard on US and Europe entry for the past decade. None of these pharmaceuticals have been successful in gaining access to the US market and have struggled to gain approval in the Europe Union, but they are much further ahead than China. (China is apparently moving mountains to catch up to their Asian competitors in Pharma business). India’s status will now change with the recent news that Pfizer will pay Biocon up to 350 million (US $) for rights to sell Biocon’s version of human insulin and insulin analogues. (Pfizer Makes Move Into Biologic Drugs) While Biocon’s insulin portfolio is not considered generic, they are near generic or biologic(al) drugs. Plans to introduce these to market should coincide when the patents for many of the branded traditional analogues expire, 2013-2017. (Lilly’s patent for Humalog expires in 2013; S-A’s Lantus in 2015 and Novo Nordisk’s patents for their analogs expire sometime during 2014-2017.) The India/American Pharma alliance is huge news, but will the result translate into a better priced insulin for consumers in the West? One indisputable fact exists: Biocon and Pfizer need their designer line of biologic insulins to placate their stakeholders and succeed financially. They also need FDA approval.
Is a Reliable Generic Coming Soon?
What will this increased pressure and global competition mean for current insulin manufacturers in the US and Europe? Pricing has continued to be a fundamental issue for diabetes care, and many see insulin as an easy replicated or reproduced commodity – analogues included. In the United States, generic insulin initiatives have been shelved and re-shelved by the FDA much to the consternation of the public, patients and many state politicians who see generic insulin as one answer to decreasing hefty state Medicare bills (States, Bridling at Insulin’s Cost, Push for Generics, 2007). Insulin is a huge financial burden for America’s health care system and for the three pharmaceutical corporations involved, the USA is the most valuable private health care market. What about advocacy? Does JDRF help or the American Diabetes Association assist with initiatives to heighten the issue of generic insulin unavailability? It appears that neither of these organizations have actively advocated for generic insulin, although they have supported many other types of valuable advocacy on behalf of diabetes patients. It is no surprise that all three insulin manufacturers (Lilly, NN and S-A) have donated millions over the years in funding and in-kind services to support the organizational activities of both JDRF and ADA crucial to their Corporate Social Responsibility (CSR) programs and corporate marketing strategies.
Fundamental to the shift in the global insulin market will be to see how the US and Europe regulatory fields adapt. Existing patents have become a shield for profits and too many people are suffering without affordable access to lifesaving insulin, and I include the modern analogues as a prescription for best care. With most of the diabetes patients in the world residing in Asia, I have long believed that science and commerce in this part of the world would quickly catch up. How exciting for patients that its arrival has occurred more swiftly than I thought possible.
Change is inevitable in the coming years and especially in this decade (2011-2020). Let’s hope the new manufacturers, in generic or biologic form, help make access and affordability a whole lot better, not solely for Asia or for the West, but for all patients, everywhere.