BIO Urges Governor Hickenlooper to Sign Bill That Ensures Patient Access to Interchangeable Biologic Medicines

Washington, D.C. (March 12, 2015) – The Biotechnology Industry Organization (BIO) and the Colorado BioScience Association (CBSA) call upon Governor Hickenlooper to sign critical legislation to create a pathway for the substitution of interchangeable biologic medicines.

The Colorado House of Representatives passed Senate Bill 71 this week, with a vote of 63-1-1. This action follows Senate passage of the same bill last month, with a vote of 34-1.

The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO and CBSA support this important legislation and encourage Governor Hickenlooper to sign the bill when it reaches his desk.

“Senate Bill 71 enjoys the support of physicians across the country, patient groups, and both innovator biologic and biosimilar manufacturing companies. This bill includes transparent communication on all biologic medicines dispensed in order to maintain a consistent and complete medical record,” said Jim Greenwood, BIO’s President and Chief Executive Officer. “This legislation represents a significant step forward, ensures transparency and communication between patients and their treatment teams, and is fully consistent with the BIO principles.”

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. Senate Bill 71 seeks to properly preserve patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies. BIO will continue to advocate for full transparency in the substitution process, as patients and their physicians should have the right to know what biologic medicine the patient receives from the pharmacy.

“This legislation will benefit Coloradoans when the first interchangeable biologics are approved by the FDA,” said April Giles, President & CEO of CBSA. “When they become available, these therapies will be safe, effective, and similar to innovator biologics. Furthermore, they will provide patients with more opportunities to address their unmet medical needs, particularly severely ill patients who rely on cutting-edge medical treatments.”

While the FDA recently approved the first biosimilar product for sale in the U.S, the agency continues to develop a pathway for the development and approval of safe and effective interchangeable biologic products the United States. In fact the FDA has indicated they expect to see applications for interchangeable biosimilar product approvals this year. However, there is still a major role for states to play in ensuring substitution practices remain transparent and physicians remain engaged in the process.

“Interchangeable biologics are not generics. Even slight changes to a biologic drug can change its properties entirely,” said Greenwood. “Unlike conventional generic medicines, interchangeable biologics are not the same as the drugs they seek to substitute. In fact, two biologics made using different cell lines and differing manufacturing processes will rarely, if ever, be exactly the same. Those suggesting interchangeable biologics and generics are the same are wrong.”

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 Colorado General Assembly continues to address issues related to biologic medicines, BIO and the Colorado BioScience Association encourage policy makers to continue to put patients first.

About CBSA
The Colorado BioScience Association (CBSA) is a not-for-profit corporation providing services and support for Colorado's growing biosciences industry. With more than 350 members, CBSA actively works to promote the growth of the industry by working for a better business environment, grow the state's biotech workforce, advocate for policies that support a strong bioscience industry in the state, and speak with a single voice on behalf of the industry. For more information, visit http://www.cobioscience.com.