THE BLOG
06/25/2012 12:18 pm ET | Updated Aug 25, 2012

Approved Pathway for Biosimilars Must Be Patient-Focused

There is no question that innovation is exploding as U.S. drug companies invest in the biotech marketplace. New biologic medicines offer the best hope for some of the most devastating and debilitating diseases, including Parkinson's disease, cancer, and Alzheimer's. However, while these drugs are being rapidly produced in countries around the world and the United States remains a leader in the efforts, the development of more affordable versions available here is still in its early phases.

Unlike chemically-produced pharmaceuticals, biologics are extremely complex. Biologics are manufactured using recombinant DNA and have molecular sizes that are several hundred times larger than chemical drugs like Tylenol. For this reason, biologics cannot be exactly replicated; instead, only similar copies or "biosimilars" can be created. Small differences in the structure of the innovator drug and the attempted copy could affect the efficacy, safety and tolerance of the drug for the patients.

Follow-on products are not allowed to be sold in the United States under an abbreviated approval pathway because of their complexity. However, with lower-cost biosimilars already available in Europe, Canada and Japan, U.S. regulators are beginning to consider a pathway that would allow them here. Although the demand for greater access to less expensive medicines is great, regulators -- specifically, the Food and Drug Administration (FDA) -- must ensure that these treatments are effective and safe.

The 2010 Affordable Care Act tasked the Food and Drug Administration with developing guidance that outlined a shortened approval pathway for biosimilar drugs. If done correctly, this pathway will safely and effectively bring copycat versions of innovative drugs to the U.S. market.

In February 2012, the FDA provided the U.S. industry with draft guidelines to introduce biosimilars. Several companies have already begun to seize the opportunity to address this challenge and begin biosimilar development. Clusters of biotech firms are popping up around the country, including many here in North Carolina. This is no surprise, as North Carolina's Research Triangle is an active site for clinical trials, research and development, job and investment opportunities.

Biosimilars have great potential to revolutionize the U.S. drug market because they are extremely effective and are highly accurate in targeting the diseased organs or cells that need to be treated. But to capitalize on their potential, the regulatory pathway set forth in the United States must be patient-focused.

The FDA must ensure that a vigilant traceability system is in place to allow for better identification of products and ultimately protect patients. And by providing a unique and distinctive naming and labeling system, the FDA will be able to document cases of adverse effects and will be better able to act quickly before they can harm patients.

The pharmaceutical industry in the United States has worked hard to become an international leader in the production of biotech drugs, and patients across the country can benefit from having access to better medicines. But as the nation introduces these new medicines, we need to ensure that safety protocols are in place -- so that every patient has the opportunity to get healthy.

For more by Eva M. Clayton, click here.

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