Indiana Legislation ensures safe access to biosimilars.February 10, 2014 -
BIO and Indiana Health Industry Forum commend Indiana State Senate for passing legislation designed to create pathway for the substitution of interchangeable biologic medicines. Legislation ensures transparency and communication between patients and their treatment teams. Policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.
Indiana Senate Passes Legislation to Ensure Safe Access to Biosimilar Therapies
Biotechnology Industry Organization
1201 Maryland Ave., SW, Ste. 900
Washington, DC, 20024
Press release date: January 30, 2014
Patients Should Be Informed if Doctor's Prescription Changed
WASHINGTON-- The Biotechnology Industry Organization (BIO) and the Indiana Health Industry Forum (IHIF) commend the Indiana State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.
The policies outlined in the identical SB 262 align with BIO’s principles on biologic substitution, therefore BIO and IHIF support passage of this bill as it moves along for consideration by the Indiana House of Representatives.
Although similar bills have been addressed in other states, SB 262 enjoys the support of a broad coalition of both 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. 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. SB 262 seeks to properly preserve patient access to accurate prescription information, maintain incentives for innovation and promote 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. Bills such as this, that properly address the important aspect of physician communication, represent model legislation necessary in all 50 states to address this cutting-edge technology.
The FDA is currently developing a pathway for the development and approval of safe and effective interchangeable biologic products in the United States. 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. 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. Providing information about substitution to 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 Indiana General Assembly continues to address issues related to biologic substitution, BIO and IHIF encourage policy makers to continue to put patients first.
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. BIO produces BIOtechNOW, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtechNOW.
The diverse members of the Indiana Health Industry Forum generate the collective voice of the state’s health and life science industry. The Forum connects key stakeholders to enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation. IHIF is the Indiana affiliate of the Biotechnology Industry Organization. To learn more, please visit www.ihif.org.
Biotechnology Industry Organization (BIO)
George Goodno, 202-962-6660