Currently, biotechnology drugs make up 10 to 15% of the pharmaceutical market in the United States, and this sector is growing faster than any other class of drugs. Biotech drugs include recombinant DNA technology, monocolonal antibodies, and gene therapy, and these drugs are revolutionizing treatment of diseases and complex conditions that previously had an unmet clinical need. The field of biotechnology is relatively new, and these drugs were like something out of science fiction novels only a few decades ago. Today, they are a reality, but they have come at a cost. The expensive and time-consuming research and development process make the drugs necessarily pricey once they are available on the market.

Now, with the original patents ready to expire within 5 years on many biotech products, a new category of drugs is emerging that may help control biotech drug costs. “Biosimilars” or “follow-on biologics” are therapeutic biological products that are similar to generic versions of brand name drugs. Biosimilars are not manufactured until the original patent expires on the innovative biological product, and are considered new non-innovative products. Biosimilars build on the research of the original product, but are not entirely therapeutically equivalent. Biosimilars are only similar in composition to a reference product, but may not be identical or even interchangeable. Generic drugs, on the other hand, are required to be identical in safety, efficacy, dose, and administration to the brand name counterpart.

In the United States, no official regulatory process yet exists for the federal approval of biosimilars. Generic equivalents of non-biotech drugs have an abbreviated approval process under the federal Food and Drug Administration (FDA), and supporters of biosimilars advocate the same type of process for the biotech sector. They also claim that the advent of less costly biosimilars will lead to more competition in the pharmaceutical marketplace and encourage research.

Challengers to the biosimilars movement maintain that prescribers who order drugs using the non-proprietary name may not intend to administer a biosimilar agent, and hospital pharmacies may not be able to afford to stock all varieties of biosimilars for a particular reference product.  Physicians, pharmacists, and patients need to be confident in the suitability and interchangeability of the biotech drugs available. The United States Congress is currently debating these issues before moving forward with an approval process for biosimilar agents.

Many editorials and reviews extol the potential virtues of less costly, yet effective, treatments for conditions like cancer and autoimmune diseases. Still, most health care practitioners and scientists respect the need for appropriate guidance and oversight in this field. The characteristics of biological products are complex, and intrinsic differences between biosimilars and reference products may render them non-interchangeable. They will very likely exhibit differences in clinical efficacy, safety, and immune system response. In sensitive and hard-to-treat conditions, these dissimilarities may be life-threatening.

With a suitable regulatory process in place, biosimilars have the potential to provide considerable cost savings to patients, health care providers, and payors. But, a comprehensive understanding of new products, including manufacturing process, prescribing habits, marketing practices, patent terms, and clinical use needs to be addressed with policy creators and decision makers before the future of biosimilars becomes a reality.

References

S. Gottlieb (2008). Biosimilars: Policy, clinical, and regulatory considerations American Journal of Health-System Pharmacy, 65 (14 Supplement 6) DOI: 10.2146/ajhp080210

P. E. Johnson (2008). Implications of biosimilars for the future American Journal of Health-System Pharmacy, 65 (14 Supplement 6) DOI: 10.2146/ajhp080212

H. Mellstedt, D. Niederwieser, H. Ludwig (2007). The challenge of biosimilars Annals of Oncology, 19 (3), 411-419 DOI: 10.1093/annonc/mdm345

R. G. Wenzel (2008). Introduction American Journal of Health-System Pharmacy, 65 (14 Supplement 6) DOI: 10.2146/ajhp080209