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BIO Testifies in Support of Biosimilars Legislation that Includes Patient and Physician Transparency

Pending Legislation will Protect Pennsylvanians Utilizing Biologic Medications to Manage Chronic Diseases and other Unmet Medical Needs</p>

Harrisburg, PA (September 11, 2013) – Fritz Bittenbender, Senior Vice President, External Affairs, Biotechnology Industry Organization, will testify today in the Pennsylvania House of Representatives, Health Committee hearing, in support of HB 746 – legislation that properly preserves patient and physician access to accurate prescription information, while promoting a competitive market for complex biologic medicines. Importantly, the bill gives pharmacists the ability to substitute lower cost interchangeable biologic medicines while also ensuring that patients and physicians have been notified of an appropriate switch in their medication.

Pennsylvania law relating to the prescription and pharmaceutical substitution of biological products must be amended to include biosimilars, 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 Pennsylvania House of Representatives Health Committee, Mr. Bittenbender will highlight four key points pertaining to biosimilars:

  • Biosimilars are safe and effective : Similar to innovator biologics, biosimilars will provide patients opportunities to address their unmet medical needs
  • Substitution should occur only when the FDA has designated a biologic product as interchangeable
  • Biosimilars are not generics: biosimilars can be highly 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 unmet medical needs. However, due to the complexity of biologic medications, biosimilars 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 innovator companies developing these medications,” said Fritz Bittenbender, Senior Vice President, External Affairs, Biotechnology Industry Organization. “However, due to the complexities of biologic medications, existing state laws governing generic substitution cannot be applied to biosimilars and we must address this issue prior to biosimilars coming to market.”