Industry Organization (BIO) and the Delaware
BioScience Association (Delaware Bio) call upon Governor Markell to
sign critical legislation to create a pathway for the substitution of
interchangeable biologic medicines.
The Delaware House of Representatives unanimously passed an amended
version of Senate
Substitute 1 for Senate Bill 118 late yesterday. This action sent
the bill back to the Senate where it received a unanimous vote today. A
similar version of this bill was originally passed by the Senate, also
by unanimous vote, last month.
The policies outlined in the bill align with BIO's
principles on biologic substitution, therefore BIO and Delaware Bio
support this important legislation and encourage Governor Markell to
sign the bill when it reaches his desk.
"Senate Substitute 1 for Senate Bill 118 enjoys the support of
physicians across the country, patient groups, and 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," 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
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 Substitute 1 for Senate Bill 118 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 Delawareans when interchangeable
biologics are approved by the FDA," said Greenwood. "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."
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 the Delaware General Assembly continues to address issues related to
biologic medicines, BIO and Delaware Bio 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
About Delaware BioScience Association
Delaware Bio is a non-profit trade association that serves its members
and the State of Delaware by collaborating with other local businesses
and organizations to advance the growth of the bioscience industry in
Delaware and the region (www.delawarebio.org).
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