Biologics & Biosimilars: What is the Science Telling Us?

Panelists from the varied backgrounds of academia, business and regulation agreed on the highest scientific standards of biosimilar regulation. Each panelist emphasized the need for the most stringent of standards in order to ensure patient safety and efficacy within the emerging biosimilars market. As Brian Liang, Executive Director of the Institute of Health Law Studies at California Western School of Law, summed it up, “the need in biosimilars is to focus on science, not cost. These are not small molecule drugs; the regulation of larger molecule drugs has the potential for much higher patient risk.”

Due to the fact that biosimilars are large, complex drugs, the regulation of this class of treatments will not be a one-size fits all approach. Each biosimilar must be held to the highest scientific standards and then evaluated further based on the specific molecule. Marie Vodicka, Ph.D., Associate Vice President of Scientific and Regulatory Affairs at PhRMA agreed, noting that “here is where the FDA is critical” both as a regulatory body and a communicator between the scientific community and the general population.

The conversation quickly moved away from regulatory processes and towards what to do once biosimilars are approved. Michael Kamarack, President of MerckBioventures, noted that in Europe, the population of nations is more homogeneous than in the United States and therefore the regulatory pathway for biosimilars there would be an inefficient model for communication and clinical trials in this country. Clinical trials must include patients from diverse populations to ensure that minorities or at risk groups do not have adverse reactions to biosimilars if they switch over from an innovator biologic or vice versa. Brian Liang emphasized that without adequate communication to doctors and their patients, biosimilar companies will be unable to convince people to switch over from an innovator biologic and therefore sell their products. Different populations need their own targeted outreach from drug companies and regulatory bodies in order to feel comfortable using biosimilars.

As the token regulator on the panel, Marie Vodicka noted that people are less inclined to adopt biosimilars because they are not sure what they are. Biosimilars are not a generic version of the treatment or therapy, and they are not an innovator biologic — they are a new class of drugs and the public must be educated on what this means in order to understand and eventually use these treatments.  Education, communication and continued review of safety and efficacy are the keys to biosimilar adoption in the United States. The panelists agreed that a regulatory pathway for biosimilars should be expected near the end of 2011.

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