Prescribing Caution for Biosimilars

Published on: 
BioPharm International, BioPharm International-04-01-2013, Volume 26, Issue 4

Sound policies are needed to govern the substitution of interchangeable biologics.

In statehouses around the country, lawmakers are beginning to address the complexities of cutting-edge biotech drugs and the regulatory issues related to the interchangeability of biosimilar medicines.

James C. Greenwood

These legislative efforts represent a significant step in recognizing the important and complex role biologic medicines play in the future of healthcare and chronic disease management. They are also a necessary measure to ensure that patients and their physicians remain in control of their medical treatment decision-making as the market for complex biologics evolves over the next several years.

Biosimilars are biologic products manufactured with the goal of closely mirroring the composition and treatment profile of an innovator biologic product, but are produced without access to the innovator's proprietary manufacturing processes.


Two biologics made using different cell lines and manufacturing processes will rarely, if ever, be exactly the same, hence the name "biosimilar." Simply put, biosimilars are not generics, and those suggesting otherwise are incorrect. Thus, current state laws governing the substitution of generics are not, and should not be, automatically applicable to biosimilars.

Patients and physicians managing chronic conditions are generally aware of which treatments work best in their unique circumstances. Therefore, the decision to change to a biosimilar treatment is best made by doctor and patient. However, at a minimum, providing notice to the prescribing doctor and patient ensures everyone in the treatment continuum is informed of decisions to switch to a different biologic drug, either at the pharmacy level or due to insurance coverage guidelines.

Until recently, there was no pathway for the development and approval of biosimilar products in the United States. The US Food and Drug Administration is currently developing such a pathway. Even after it is enacted, the policy on whether one biologic product may be substituted by dispensers when a different biologic product was prescribed will continue to be governed by state law.

At present, most state laws need to be updated to address the commercialization and distribution of new biologic products and their biosimilar competitors, which are set to enter the marketplace over the next few years. Sound policy in each state outlining the parameters for safe substitution of interchangeable biologics is the best option to ensure patients have access to the most effective and appropriate treatments possible.

Recognizing the authority US states have over biosimilar and interchangeable biologic medicines, the Biotechnology Industry Organization (BIO) developed five principles on biologic substitution that we believe should be considered by all states when evaluating biosimilar legislation. Briefly stated, these principals are:

  • Substitution should occur only when FDA has designated a biologic product as interchangeable

  • The prescribing physician should be able to designate a prescription as not substitutable

  • The prescribing physician should be notified of the substitution if one occurs after the prescription is ordered

  • The patient, or the patient's authorized representative, should, at a minimum, be notified of the substitution

  • The pharmacist and the physician should keep records of the substitution.

These principles strike the appropriate balance of preserving the physician-patient relationship, protecting patients, and promoting a competitive market for biologic therapies. We welcome the opportunity to further discuss this issue with lawmakers as they seek to address vital drug safety measures that accompany this cutting-edge technology.

James C. Greenwood, President & CEO of the Biotechnology Industry Organization.