Indianapolis, IN (October 22, 2013) – Fritz Bittenbender, Senior Vice President, External Affairs, Biotechnology Industry Organization, testified today before the Indiana Health Finance Commission in support of proposed legislation that properly preserves patient and physician access to accurate prescription information, while promoting a competitive market for complex biologic medicines.
Importantly, the proposed legislation gives pharmacists the ability to substitute lower cost interchangeable biologic medicines while also protecting the patient-physician relationship by ensuring the physician is notified when a switch in the patient’s medication has been made at the pharmacy level.
Indiana law relating to the prescription and pharmaceutical substitution of biological products must be amended to include interchangeable biologics, ensure consistency in the system, safeguard the primacy of the physician-patient relationship and forward transparency and communication between patients and their treatment teams.
In his testimony to members of the Indiana Health Finance Commission, Bittenbender highlighted four key points pertaining to the substitution of biological products:
Biosimilars and interchangeable biologics, once approved by the FDA, will be safe and effective: Similar to innovator biologics, they will provide patients with additional options to address their medical needs
Substitution at the pharmacy level should occur only when the FDA has designated a biologic product as interchangeable
Biosimilars are not generics: biosimilars will be similar to the innovator biologic medicines they seek to replicate but are not exactly the same. Therefore the policy issues surrounding these medicines are different than those associated with generic medications
Transparency between physicians, patients and pharmacists, as well as all appropriate parties in the patients care continuum, is imperative so that any immunogenicity issues or adverse reactions from innovator biologics, biosimilars or interchangeable biosimilars can be documented and appropriately addressed.
Biosimilars are biologic medications that are similar to innovator products but are not identical and will provide patients with more options to treat chronic diseases and other medical needs. However, due to the complexity of biologic medications, they should only be substituted for innovator biologics if the FDA has designated them as interchangeable.
“Ensuring access to these potentially life-saving medications is a shared goal with advocacy organizations and the innovator companies developing these medications,” said Bittenbender. “However, due to the complexities of biologic medications, existing state laws governing generic substitution should not be applied to biosimilars, and we must address this issue prior to biosimilars coming to market.”