The XIX International AIDS Conference (AIDS 2012) was convened from July 22-27 in Washington, DC. This was an historic moment - not only because it was the first of these biennial conferences to be held on this nation's soil since 1990; but also because it took place amid rapid expansion and development of new, innovative therapies for treatment and prevention.
During his plenary lecture, "Ending the HIV/AIDS Pandemic: From Scientific Advances to Public Health Implementation", Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, stressed that the robust arsenal of antiretroviral drugs and scientifically proven interventions now available to treat and prevent HIV infection offers unprecedented opportunities to make major gains in the fight against HIV/AIDS and ultimately end the pandemic.
Over the past three decades, the accumulation of scientific knowledge has enabled scientists to better understand the virus and know what interventions work. While there's still no cure and no vaccine, there are over 30 licensed drugs currently on the market. For persons with HIV and AIDS, biologic medicines are the cutting-edge drugs that hold the promise to transform their lives. As the name suggests, biologic medicines are created using biologic materials -- living starter cells. These cells are then manipulated in a lab to produce large, multifaceted compounds. The end-result is both complex and genetically complicated.
The U.S. Food and Drug Administration (FDA) has helped to layout an initial framework to a pathway for follow-on versions of biologic drugs, or biosimilars, since first tasked with the responsibility in 2010. But before any new medicines are approved for broad consumption, there are still several issues that must be resolved to ensure that these medicines are safe.
Most Americans are familiar with generic drugs. At the pharmacy, one can purchase either the innovator drug or the generic version. According to the FDA, a generic pharmaceutical must have the same active ingredient, dosage form, strength, route of administration, quality and performance characteristics, and intended use as the brand name product. This is possible because generic drugs are produced in an identical fashion with the same chemical molecules.
Biotech medicines are very different. By virtue of their unique starter cells, it is impossible for another pharmaceutical laboratory to perfectly replicate the innovator biologic medicine. Scientists can certainly get close though, which is why these copycat medicines have been dubbed biosimilars.
The FDA has the opportunity to take several extra steps that will create a standard to ensure that biosimilars are safe for their patients. Rigorous clinical trials coupled with a vigilant tracing program will limit the number of adverse effects experienced by patients. Also, giving each new biosimilar a unique name and distinct label will help physicians and pharmacists recognize the medicine and determine whether it is suitable for a particular patient. States must also ensure that physicians and pharmacists are notified if a patient is switched from the innovator biologic to its biosimilar.
A few additional precautions will make an enormous difference in assuring health care providers that these medicines are safe for patient use. With the proper safeguards in place, patients can be assured that they have access to these biosimilars and have hope for an enhanced quality of life as they live with HIV/AIDS. For example, biologics are currently used to treat anemia, which is a serious complication seen in 95% of people with HIV and AIDS. Further, new monoclonal antibody therapies in development (including Progenics' PRO 140, and Tanox's TNX-355) hold promise for HIV-positive patients who no longer respond to other drugs. And in the future, biosimilar versions of these medicines will increase accessibility for all patients.
Thirty years in, the U.S., indeed the planet, is making great strides in HIV and AIDS research. Dr. Fauci's vision of an AIDS-free generation will only be realized with innovative biologic and biosimilar medicines that are effective in and accessible by all affected populations. The continuing challenge is harnessing the societal and economic will and resources to make it a reality.
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