As part of $3K in 3 Weeks, here is another in a series of articles on current issues and topics related to Crohn’s disease and ulcerative colitis.
Did you know that biologics1 such as Remicade, Humira, and Cimzia – used in the treatment of Crohn’s disease and ulcerative colitis – are governed by different rules and laws than other traditional medications? As a result, there currently are no approved generic biologics in the U.S. So while you might be able to buy a generic version of a brand name pain killer or blood pressure medication, you can’t buy generic Remicade (at least not legally).
Why are generic biologics not available, and is that likely to change?
To answer those questions, we need to start with a quick history lesson: The generic drug industry arose in 1984 when the Hatch‐Waxman Act made it much easier (and much less expensive) for qualified companies to produce a molecularly identical version of a drug after its patent had expired. (Prior to Hatch‐Waxman, a company wishing to manufacture a generic drug would have had to repeat the full – and costly – clinical studies and the same FDA approval process that the original manufacturer went through.)
When Hatch‐Waxman passed in 1984, biologics were still in the realm of science fiction. Thus that law was written in a way that did not address or even anticipate the emergence of biologics.2
Caution: If you google “generic Remicade” or “generic infliximab”, you’ll find numerous vendors trying to sell you what they claim is a less expensive, generic version of Remicade. Buyer beware! Since under the current rules and laws, generic biologics are not available, you are about to be scammed. At a minimum, those so‐called generics are fakes, and potentially dangerous.3
Since 2001, there have been a number of attempts in the U.S. to develop guidelines (and ultimately laws) to allow and govern production of generic versions of biologics, but none of the those attempts have succeeded. Which brings us to today and the era of U.S. health care reform.
Creation of a legal framework for biologics is one of many issues addressed in the version of the health care reform bill passed by the House of Representatives on November 7.4 That legislation employs the concept of “similarity” — similarity means the FDA would need to be satisfied that a generic biologic is similar enough to the original biologic (both in terms of molecular composition and specific manufacturing process) that it will perform in the same way and yield the same results for patients.
The bill also sets a 12‐year period of market exclusivity for a new biologic agent before any similar biologic product could be approved, even in the absence of a patent. This market exclusivity is intended to protect the investment made in developing, testing and securing approval for the original biology.
Ultimately, the goal of any generic biologic legislation should be to set a balance between innovation and costs savings, in the same way that the Hatch‐Waxman Act of 1984 led to less expensive generic drugs without stifling new drug innovation. As to whether the current legislation will succeed in achieving such a balance, there are strong voices on both sides. The Senate plans to vote on its version of health care reform (called “America’s Healthy Future Act”) in the next few days, so we’re likely to move soon into the next stage of the debate over generic biologics.
What’s your opinion on generic biologics, whether they should be available, and how they should be approved and regulated? Express yourself in the Comments box below.
Additional Resources on Generic Biologics
Additional $3K in 3 Weeks Articles
This article is part of the $3K in 3 Weeks initiative. Click to view all of the $3K in 3 Weeks articles.
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Crohn’s disease and ulcerative colitis, known collectively as inflammatory bowel diseases (IBD), are painful, medically incurable digestive diseases. Approximately 1.4 million Americans are afflicted, including over 140,000 children. Most often striking young adults, IBD exacts a heavy toll in acute care, and can often involve multiple surgeries, hospitalizations, and in rare cases, untimely death. Although we have made significant progress in treating Crohn’s disease and ulcerative colitis in recent years, we do not yet have cures or means of prevention.
—Excerpted from Voices of Progress, CCFA Annual Report 2008
- Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combination of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources – human, animal, or microorganism – and may be produced by biotechnology methods and other cutting‐edge technologies. Gene‐based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available. — Source: U.S. Food and Drug Administration [↩]
- Hatch‐Waxman identifies drugs on the basis of a precise chemical composition, which each drug is literally defined down the last atom. A biologic, however, has a much higher molecular complexity, is usually derived (cloned) from a unique cell bank and can be produced only through a very precise manufacturing process. As a result, a biologic is not defined by an exact molecular structure, but rather by the precise process used to produce it. [↩]
- By the way, infliximab is the active ingredient in Remicade, not a generic name for Remicade. [↩]
- H.R. 3962 Affordable Health Care for America Act: Sections 2575 to 2577 focus on biologics [↩]