|[January 30, 2014]
Indiana Senate Passes Legislation to Ensure Safe Access to Biosimilar Therapies
WASHINGTON --(Business Wire)--
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
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.
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