A Safe Pathway to Biosimilars

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What are the similarities between Alzheimer’s, Parkinson’s, HIV/AIDs, and breast cancer? All are life-threatening medical conditions, of course. All cause pain for patients and their family members. And all are being treated by cutting-edge biologic medicines which came about through several scientific advances in the last few decades.

Today biologics offer a bright alternative for patients diagnosed with debilitating diseases and conditions. In contrast with traditional chemical drugs, these advanced medicines are made from organic materials. Scientists start with tissue, blood, or stem cells and, through biologic processes, create complex compounds that can successfully alter the course of a disease to provide precious time and hope to patients. In 2010, the U.S. Congress approved the development of a pathway for biosimilar medicines, which are imitative versions of biologic drugs.

Biosimilars are a new class of products, not identical copies but similar to already approved biologics. Biosimilars are created from different starter cells and are produced through distinct manufacturing processes. As a physician, I am excited about the potential that biosimilars offers for my patients both in terms of quality and reduced cost. However, I believe that the success of biosimilars is tied to the confidence that all physicians who will prescribe them have in the process the Food and Drug Administration (FDA) employs to make them available in the U.S.

There is significant room for variation between a biologic and its follow-on counterpart so it is up to the FDA to ensure that biosimilars undergo robust clinical measures to demonstrate that there are no meaningful differences in terms of the safety, purity, and potency of the product. Clinical testing also enables a rigorous examination of the side effects of these advanced medicines and could offer the chance to register adverse reactions associated with a product before it enters the U.S. market.

Recently, the FDA issued a series of draft guidance documents that outlined the approach the agency would take to make biosimilars available for patients in the U.S. While the guidance documents emphasized that the FDA was rightly focused on safety, they failed to provide clarity around what measuring stick the FDA will use to determine if a product is similar. We know that clinical trials could be used to prove that they are trustworthy.

But we need to find the questions that must be answered by manufacturers of biosimilars to make doctors rest easy when prescribing them. Ultimately, we want to have the same confidence in biosimilars that we have in biologics, but that can only happen if the FDA is clear and specific about the standards to which it is holding biosimilar manufacturers and if the data is available to the public.

An example of this is what level of difference in adverse events will be considered clinically significant? And if clinical trials will not be necessary in the evaluation of a particular biosimilar what constitutes the scientific justification for not doing them since they are the gold standard in the evaluation of clinical drugs? As the guidance is completed, it’s important that the FDA’s data requirements for the approval of a biosimilar as well as a designation of ‘interchangeability’ reflect that a biosimilar is similar to, but never identical to its innovator biologic.

Thus the decision to substitute a biosimilar for a biologic should never be made by the pharmacy or an insurer without physician consent. Only patients acting with the advice of their physicians should decide the best course of their own treatment. And finally, the FDA must oversee the naming of new biosimilar medicines. Each medicine should be given a unique name to be easily tracked and traced.

Naming is of the utmost importance to ensure that drugs can be recalled with ease in the case of an adverse event. Biotech medicines offer promising treatments to some of the worst medical conditions. With an FDA guideline that ensures patients as its top priority, biologic and biosimilar medicines can continue to improve the lives of patients and their families.

Dr. Dolinar is Chairman of the Alliance for Safe Biologic Medicines and is a practicing endocrinologist based in Phoenix, AZ.


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