A major Indian biotechnology company just announced it is breaking into the exciting field of biologic medicines. Zydus-Cadila has successfully manufactured a rough copy of a popular autoimmune disease biologic called Humira. The firm has about two dozen other biologic products under development.
This news was largely met with enthusiasm by the American healthcare establishment. Biologics are complex pharmaceuticals derived from living organisms that have proven highly effective in combating cancer, diabetes, and other serious diseases. Indian versions of biologics tend to be significantly cheaper than their brand name counterparts. In fact, Zydus-Cadila’s new drug is expected to be one fifth the price of Humira.
But India’s rise as a major player in the biologic market is not an unalloyed good. The country has a terrible track record when it comes to creating safe and effective pharmaceuticals. American officials will need to install robust quality controls on Indian biologics. Otherwise, millions of patients in this country could be exposed to ineffective and even downright dangerous medicines.
Earlier this year, the Indian generic firm Dr. Reddy’s Laboratories recalled over 13,500 bottles of a blood pressure drug due to problems with pill solubility. The firm has also withdrawn 58,000 bottles of another medication because of microbial contamination. Wockhardt, another large Indian producer, has also been forced to recall an astonishing 110,000 bottles of the exact same blood pressure drug because of the exact same problem.
As Bloomberg News just revealed in an investigative report, a lab technician at an Indian research facility run by Sun Pharma deleted the data from a test evaluating the safety of a major drug line only a few years ago. That data showed dangerous impurities. Shortly after, the drug was declared clean and shipped off to American patients, exposing them to untold health risks.
Likewise, last May, Ranbaxy, one of the largest drug companies in the country, was slapped with half a billion dollars in fines by an American court for lying about drug quality. And the FDA forcibly shut down and banned some its production plants.
The list goes on — because these problems in Indian drug production are widespread. Work from Harvard Medical School found that 30 different, mostly Indian-sourced versions of the most popular pharmaceutical in the world — atorvastatin, a generic version of the cholesterol drug Lipitor — contained significant impurities.
The manufacturing process for traditional chemical pharmaceuticals is significantly less complicated than that of biologics drugs. Part of what makes the latter so powerful is their complexity — and that complexity demands extreme precision in production.
There is no such thing as a generic biologic drug — these medications are too complex to perfectly copy. However, it is possible to produce a rough equivalent of a brand name biologic called a “biosimilar” that has approximately the same therapeutic effects.
Even minor flaws in a crucial production stage, such as the creation of the host cell, can affect biosimilar makeup. And even small differences between a biosimilar and the biologic it is based on can compromise its therapeutic power, rendering the drug ineffective or causing unexpected side effects.
The Indian drug industry has clearly demonstrated that it is currently incapable of consistently producing high-quality chemical pharmaceuticals. Firms cut corners and dodge regulators. There’s no reason to believe this industry can take on the much more difficult task of responsibly producing biosimilars.
After the Federal Aviation Administration discovered serious safety problems with Indian airline companies, it immediately downgraded their status and limited their ability to serve American customers. In so doing, the FAA created clear incentives for Indian authorities to step in and force the problematic carriers to shape up or shut down.
The FDA should do likewise and put the onus on Indian officials to ensure safety and quality in biosimilar production.
American regulators need to act fast. The Indian biologic industry is set for explosive growth.
Next year, patent protections will expire on about $80 billion worth of biologics. Indian — and Chinese — drug firms will jump at the opportunity to start producing biosimilars to supply the market. The Omics Group, a global publisher of scientific journals, predicts that these two countries alone could soon constitute 70 percent of the global drug market.
With proper regulation, Indian biosimilars could offer American patients a low-cost alternative to pricey brand name biologics. But if these drugs flood the domestic market without proper safety controls in place, they could have devastating effects on American well-being.
Biologics represent a profound leap forward in the way we combat disease. If India wants to take part in — and profit off of — this revolution, it will have to start playing by the rules.
Roger Bate is an Adjunct Fellow at the American Enterprise Institute and the author of Phake: The Deadly World of Falsified and Substandard Medicine.