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
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.