BIO Urges Governor Deal to Sign Bill That Ensures Patient Access to Biologic Medicines
Monday, March 30, 2015
Posted by: Angela King
Transparent communication important for Patients and Physicians
WASHINGTON--(BUSINESS WIRE)--The Biotechnology Industry Organization (BIO) calls upon Governor Deal to sign critical legislation to create a pathway for the substitution of interchangeable biologic medicines.
“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.”
The Georgia Senate passed Senate Bill 51 last week with a vote of 43-3. This action follows a unanimous vote on the same bill in the House.
The policies outlined in the bill align with BIO’s principles on biologic substitution, therefore BIO supports this important legislation and encourages Governor Deal to sign the bill when it reaches his desk.
“Senate Bill 51 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 CEO. “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 51 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 Georgians when the first interchangeable biologics are approved by the FDA. 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. 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 Georgia General Assembly continues to address issues related to biologic medicines, BIO encourages 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.
Biotechnology Industry Organization (BIO)
George Goodno, 202-962-6660
Source: Business Wire, http://www.businesswire.com/news/home/20150330005585/en/BIO-Urges-Governor-Deal-Sign-Bill-Ensures#.VR8hO-HwfwA