|[June 25, 2014]
Massachusetts Governor Patrick Signs Bill Granting Patient Access to Interchangeable Biologic Medicines
SAN DIEGO --(Business Wire)--
Industry Organization (BIO) and the Massachusetts
Biotechnology Council (MassBio) commend Massachusetts Governor Deval
Patrick for signing legislation yesterday designed to create a pathway
for the substitution of interchangeable biologic medicines.
The policies outlined in House
Bill 3734 align with all
five of BIO's principles on biologic substitution. BIO and MassBio
commend Massachusetts's Senate and House of Representatives for passing
this legislation earlier this month. Governor Patrick announced
yesterday at the 2014
BIO International Convention that the bill had been signed.
"This important legislation enjoys the support of physicians across the
country, patient groups, and both biologic and biosimilr manufacturing
companies," said Jim Greenwood, BIO's President and Chief Executive
Officer. "By signing this bill into law, Governor Patrick added
Massachusetts to a growing list of states that have taken a leadership
position in allowing retail pharmacies to substitute interchangeable
"We're so excited that once again Massachusetts is leading the way in
adopting policy that not only supports a growing industry, but more
importantly allows patients access to the most cutting-edge therapies
that have been proven safe and effective," said Robert K. Coughlin,
President & CEO of MassBio, the state's life sciences trade association.
"We are fortunate to have visionary leaders like Governor Patrick,
Senate President Therese Murray and House Speaker Robert DeLeo who are
willing to stand up for innovation and patient safety."
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. House Bill 3734 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
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
medicines, BIO encourages policy makers to continue to put patients
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
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