Industry Organization (BIO) and the Indiana
Health Industry Forum (IHIF) commend Indiana Governor Mike Pence for
signing legislation today designed to create a pathway for the
substitution of interchangeable biologic medicines.
The policies outlined in Senate
Bill 262 align with all
five of BIO's principles on biologic substitution. BIO and IHIF
furthermore commend Indiana's Senate and House of Representatives for
passing this bill by wide margins earlier this year.
"Senate Bill 262 received overwhelming bipartisan approval and was
supported by a broad coalition of biologic and biosimilar manufacturers,
along with industry, physician and patient groups," said Jim Greenwood,
BIO's President and Chief Executive Officer. "By signing this bill into
law, Governor Pence added Indiana to a growing list of states, including
Florida, Virginia, Oregon, Utah, and orth Dakota, that have taken a
leadership position in allowing commercial pharmacies to dispense this
class of cutting-edge medical therapy."
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 262 seeks to properly preserve
patient access to accurate prescription information, maintains
incentives for innovation and promotes 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
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," 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 other states continue to address issues related to biologic
substitution, BIO encourages policy makers to continue to put patients
BIO represents more than 1,100 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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