In March of this year President Obama signed the Patient Protection and Affordable Care Act into law. This is a piece of legislation that authorizes the FDA to implement a shortened approval process for biological products biosimilar to previously approved biological medicines. The ground to be crossed toward approval looks to be rough and hazard strewn. Pharmaceutical consultants may prove to be a valuable asset in guiding companies through this apparently thorny regulatory tangle.
The aim of this legislation is, apparently, the same as similar legislation for generics- that is, to produce and improve access to cheaper drugs and thus to lighten the financial burden for both patients and the healthcare industry. The problem, though, is that there are likely to be far more testing and regulatory complications.
Generic drugs are exact chemical copies of brand-name drugs. A biosimilar, however, is not identical to the brand-name product. Biosimilars are made up of large, often complex proteins produced inside living cells, and very slight differences can produce widely divergent reactions in patients. Therefore, the regulatory approval process a biosimilar has to go through is far more complicated than for a generic and involves human clinical trials as well.
Among industry analysts, the fear on the economic side has been that this legislation, when passed, would look far too much like the Hatch-Waxman Act of 1984, which set the stage for the current generic industry. In that scenario, both the “make-hay” and the “blockbuster” effect would be exacerbated. Smaller companies and start-ups would then, in effect, be nudged out of the competitive picture.
The so-called “make-hay” effect, which came into being after Hatch-Waxman took effect, describes the phenomenon of pharmaceutical companies’ having to make as much money as soon as they can after introducing a new drug. This means that they usually have to raise prices and invest more in marketing and less in innovation. The “blockbuster” effect, most are familiar with. After Hatch-Waxman, companies had to concentrate on bringing to market drugs that had either high patient populations or high value. There appears to be fertile ground here for pharmaceutical consultants to assist drug companies in growing competitiveness and raising profitability.
In early November, representatives from various segments of the drug industry met at the FDA headquarters in Rockville, MD, to hammer out ways to implement and regulate the still inchoate regulatory pathway for follow-on biologic medications (biosimilars). During this important discussion among representatives from pharmaceuticals, generics, and biotechnology, a few common threads could be picked out.
For example, Sara Radcliffe, BIO Executive Vice President – Health, emphasized patient safety and innovation incentives. Similarly, Marie Vodicka, PhRMA’s Associate Vice President for Scientific and Regulatory Affairs, pressed for ensuring patient access to safe biosimilars, creating a science-based approval pathway involving a transparent process, and encouraging innovation and competition. And Joe Militech, Amgen’s Senior Vice President of R&D, averred, “Put patients first and sound policy will follow…. The question before the agency is how we can minimize patient risk and uncertainty associated with the approval of biosimilars.” This seems, then, a pretty clear indication of where things are headed and suggests a growing role for pharmaceutical consulting.
New ground is opening up now in the area of biosimilars in the US. And it can be profitably fertile ground when pharmaceutical companies and pharmaceutical consultants meet on it.
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