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BIO & Kentucky Life Sciences Council Support Bill Ensuring Patient Access to Interchangeable Biologic Medicines

March 17, 2016

Frankfort, KY (March 17, 2016) – The Biotechnology Innovation Organization (BIO) andKentucky Life Sciences Council (KLSC) today voiced support for Kentucky Senate Bill 134, legislation that properly preserves patient and physician access to accurate prescription information, while promoting a competitive market for complex biologic medicines.

This important piece of legislation gives pharmacists the ability to substitute lower cost interchangeable biologic medicines while safeguarding the primacy of the physician-patient relationship and maintaining communication between patients and their treatment teams.

The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO and KLSC support this legislation and are grateful for bipartisan support and leadership on this issue.

Following today’s House Health and Welfare Committee hearing, BIO and KLSC highlight four key points pertaining to biosimilars:

  • The full spectrum of biologic medicines are safe and effective: Similar to innovator biologics, interchangeable biologics 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 and interchangeable biologics are not generics: interchangeable biologics will be highly similar to the innovator biologic medicines they seek to replicate but not exactly the same. Therefore the policy issues surrounding these medicines are different than those associated with generic medications
  • Communication 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

“We are pleased to see Kentucky legislators leading the way in adopting policies that not only support a growing industry in our state, but more importantly allow patients access to safe and effective therapies to treat chronic conditions,” said Kyle Keeney, Executive Director of the Kentucky Life Science Council. “We encourage the House of Representatives to pass this legislation that will allow for more treatment options with potential cost savings and will also improve patient safety by ensuring that the prescribing physician is always notified of the exact medication dispensed.”

“Ensuring access to these potentially life-saving medications is a shared goal with patient groups and both innovator biologic and biosimilar manufacturing companies,” said Patrick Plues, Senior Director, State Government Affairs, BIO. “Due to the complexities of biologic medications, existing Kentucky laws governing generic substitution cannot be applied to biosimilars and we must address this issue prior to interchangeable biologics coming to market.”

While the U.S. Food and Drug Administration (FDA) oversees approval of biologic medicines and designation of interchangeability, policies governing whether one product may be substituted in place of a doctor's prescription and whether a pharmacist must inform patients and doctors are covered by state law.

Patients and physicians managing chronic conditions are generally aware of which biologic treatments work best in their unique circumstances. Communicating with patients and physicians allows everyone involved the opportunity to discuss past treatment experiences so that any possible unexpected issues can be better understood and avoided.

As the Kentucky Legislature continues to address issues related to biologic medicines, BIO and KLSC encourage policy makers to continue to put patients first.

About KLSC 
The Kentucky Life Sciences Council (KLSC) is a statewide association focused on developing the life science industry in Kentucky. KLSC works to educate both state and federal policymakers, the media, and the public about how legislative policies will affect the growth and development of the life sciences industry.

About BIO
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO's blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

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