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 an expedited approval process for biologics that are biosimilar to previously approved biologic drugs. The terrain that will be crossed towards approval appears to be rugged and fraught with danger. Pharmaceutical consultants can be a valuable asset in guiding companies through this seemingly thorny regulatory tangle.
The objective of this legislation is apparently the same as similar legislation for generics, i.e. to produce and improve access to cheaper medicines and thus lighten the financial burden on both patients and the pharmaceutical industry. health. The problem, however, is that there is likely to be a lot more testing and regulatory complications.
Generic drugs are exact chemical copies of brand name drugs. However, a biosimilar is not identical to the brand name product. Biosimilars are made up of large, often complex proteins produced inside living cells, and very small differences can lead to widely divergent reactions in patients. Therefore, the regulatory approval process that a biosimilar must go through is much more complicated than that of a generic and also involves clinical trials in humans.
Among industry analysts, the fear on the economic side has been that this legislation, when passed, will look too much like the 1984 Hatch-Waxman Act, which laid the groundwork for today’s generic industry. In that scenario, both the “hay making” effect and the “blockbuster” effect would be exacerbated. Smaller companies and start-ups would then, in effect, be pushed out of the competitive landscape.
The so-called haymaking effect, which emerged after Hatch-Waxman went into effect, describes the phenomenon of drug 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 spend more on marketing and less on innovation. The “blockbuster” effect, with which most are familiar. After Hatch-Waxman, companies had to focus on bringing drugs to market that had a high patient population or high value. There seems to be fertile ground here for pharmaceutical consultants to help pharmaceutical companies increase their competitiveness and increase their profitability.
In early November, representatives from various segments of the pharmaceutical industry met at FDA headquarters in Rockville, MD, to discuss ways to implement and regulate the still-nascent regulatory pathway for follow-on biological drugs (biosimilars). During this important discussion between pharmaceutical, generic and biotech representatives, some common threads could be identified.
For example, Sara Radcliffe, Executive Vice President of BIO – Health, emphasized patient safety and incentives for innovation. Similarly, Marie Vodicka, associate vice president of scientific and regulatory affairs at PhRMA, pushed to ensure patient access to safe biosimilars, creating a science-based approval pathway that involves a transparent process, and encouraging innovation and competition. . And Joe Militech, Amgen’s senior vice president of R&D, said, “Put patients first and you’ll follow a strong policy… 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 an increasing role for pharmaceutical consultancy.
New ground is now opening up in the area of biosimilars in the US and it can be profitable fertile ground when pharmaceutical companies and pharmaceutical consultants find themselves on it.