By
Donald Zuhn —

Patient Groups Back Senate
and House Committee FOB Legislation

In
September, twenty-seven patients' groups sent a letter to Sen. Harry Reid (D-NV), Sen.
Mitch McConnell (R-KY), Speaker of the House Nancy Pelosi (D-CA), and Rep. John
Boehner (R-OH), expressing their "strong support for the inclusion of a
regulatory pathway for biosimilars in the America's
Affordable Health Choices Act of 2009."  The groups urged Congress "to
identify the appropriate balance between access, patient safety, and the need
for continued innovation," and noted that they "were heartened to see
complementary amendments passed by both Committees of jurisdiction in the
Senate and House with strong bi-partisan support" (see "Senators Champion 12-Year Data Exclusivity in
Senate"
and "House Committee Approves Health Care Reform Bill Calling for 12-Year
Exclusivity Period").  In particular, the groups expressed support
for "the important, compromise Hagan/Enzi/Hatch and Eshoo/Inslee/Barton
amendments which establish a regulatory pathway for biosimilars."

The
signatories to the letter include:  AA CSA Foundation, Alliance for Aging
Research, American Association of Orthopaedic Surgeons, American Autoimmune
Related Diseases Association, American Institute for Medical and Biological
Engineering, Californians for Cures, CANN – Community Access National Network, Celiac
Disease Center at Columbia University, Children's Tumor Foundation, Colon
Cancer Alliance, Community Health Charities, Dystonia Medical, Research
Foundation, Easter Seals, Hereditary Disease Foundation, Immune Deficiency
Foundation, In Need Of Diagnosis, Inc., International Cancer Advocacy Network,
Lung Cancer, Circle of Hope, Men's Health Network, MLD Foundation, National
Alliance on Mental Illness, Parkinson's Action Network, Research for Cure, RetireSafe,
The AIDS Institute, Vietnam Veterans of America, and Vital Options
International.

DelawareBio and BIO Seek
Support of Delaware Delegation

On
Monday, Bob Dayton, the President of the Delaware BioScience Association, and
Jim Greenwood, the President and CEO of the Biotechnology Industry Organization
(BIO), co-authored a letter
on delawareonline, encouraging
Delaware Sen. Thomas Carper (D), Sen. Edward Kaufman (D), and Rep. Mike Castle
(R) to join them "in supporting a biosimilars pathway that protects
patient safety and encourages continued innovation."  Noting that Senate and House committees
had passed health care reform amendments that would establish a follow-on
biologic regulatory pathway — as well as provide a 12-year data exclusivity
period for biologic drug makers (see
"Senators Champion 12-Year Data Exclusivity in Senate"
and "House Committee Approves Health Care Reform Bill Calling for 12-Year
Exclusivity Period"),
Mr. Dayton and Mr. Greenwood contend that "[t]he pathway to regulatory
approval of biosimilars included in the House and Senate health care reform
bills will ensure that these medicines are tested for safety while expanding
access, lowering costs through expanded competition and providing incentives
for biotech companies to continue innovating."  The biotech industry leaders also noted that "[p]atient
advocates, doctors, labor unions, universities and governors, including Gov.
Jack Markell, agree that the provisions must be included in the final health
care bill" (see "Governors
Send Letter to Congressional Leaders in Support of 12-Year Data Exclusivity
Period").

Coalition for a
Competitive Pharmaceutical Market Asks Congress to Fix FOB Provisions of Health
Care Reform Legislation

Last
week, the Coalition for a Competitive Pharmaceutical Market (CCPM)
released a statement
"appealing to Congress to fix the excessive 12-year market exclusivity and
ever-greening provisions for biologics or drop it altogether."  CCPM Chair Annette Guarisco stated that
coalition members "would rather have the status quo than legislation that guarantees
profits for a few at the expenses of the American public."  In its release, the CCPM noted that a
letter had been sent to Sen. Harry Reid (D-NV) and Speaker of the House Nancy
Pelosi (D-CA), "urg[ing] lawmakers to resolve the current provision that will
create an ineffective pathway to bringing biogenerics or biosimilars to
patients and consumers," and "implor[ing] Congress not to overlook
the immediate opportunity to bend the long-term cost curve of health care
through a workable pathway for biogenerics."

The CCPM pointed to a recent Time magazine article (see "Time Magazine on Data Exclusivity
Debate")
as evidence of the "skepticism among the American public, pharmaceutical
researchers, medical students, and industry economic experts about the results
of BIO and PhRMA's influence on the health care reform deal."  The group also pointed to a paper in
the New England Journal of Medicine (see "NEJM Authors Say Five Years of
Data Exclusivity Would Be Sufficient"),
which the CCPM contends "highlights the shortcomings of biologics
provisions [in current health care reform legislation]."  In particular, the group says the article indicates that biosimilar
legislation "would have no value because it would create a pathway that
would scarcely be used," and further, "would allow for
'ever-greening,' or for manufacturers to obtain an additional 12-year
exclusivity period by making minor changes to the structure of an approved
product."  The group concludes
that "[f]inding the right balance between incentives for innovation and
timely access to care means that Congress needs to fix or drop the current
biogenerics provision [in health care reform legislation]."

According
to the CCPM website,
the group has 33 participating members, which include Apotex, Hospira, Momenta
Pharmaceuticals, Mylan Labs, Ranbaxy Pharmaceuticals, Teva Pharmaceuticals USA,
Watson Pharmaceuticals, and the Generic Pharmaceutical Association (GPhA).

TJU Dean Asks Congress to
Focus on Patient Safety

In
a letter
to the congressional daily The Hill, Dr.
David Nash (at right), Dean of the Jefferson School of Population Health at Thomas
Jefferson University in Philadelphia, PA, urges Congress not to ignore "the
broader need of ensuring patient safety" when crafting a follow-on
biologics (FOB) regulatory pathway in current health care reform legislation.  Dr. Nash, who last spring moderated a
policy forum entitled:  "Regulation
of Follow-on Biologics: Ensuring Quality and Patient Safety" at the
National Press Club in Washington, DC (see
"Follow-on Biologics News Briefs – No. 3"),
noted that much of the FOB discussion has focused on the issue of data
exclusivity.  He contends that
"[t]his focus is extremely shortsighted, and ignores the broader need of
ensuring patient safety for both current and future drugs."  Stating that "it is not possible to
create an identical biologic copy of the original drug because of the living
proteins and carbohydrates used to make them," Dr. Nash warns that "the
complexity of the genetic engineering demanded for producing [follow-on biologics]
creates serious safety concerns." 
As a result, "[q]uestions of patient safety that hinge on the
interchangeability and immunogenicity of FOBs can be answered only through
rigorous and comprehensive human testing."  Dr. Nash also contends that FOBs should be subject to
post-marketing study and surveillance. 
He concludes that "[o]nly these actions can ensure that we're
placing a higher premium on patient safety than other considerations."

    By
Donald Zuhn —

Last
Thursday, Rep. John Dingell (D-MI) introduced the Affordable Health Care for
America Act (H.R. 3962) in
the House of Representatives.  The
1,990-page bill, which was co-sponsored by Rep. Robert Andrews (D-NJ), George
Miller (D-CA), Frank Pallone, Jr. (D-NJ), Charles Rangel (D-NY), Pete Stark
(D-CA), and Henry Waxman (D-CA), includes a section (§ 2575) providing for
the establishment of a licensure pathway for biosimilar biological products.

With
regard to the issue of interchangeability, the bill states that a biological
product (i.e., follow-on biologic or
biosimilar) shall be determined to be interchangeable with a reference product
(i.e., innovator biologic) if
information is provided showing that "the biological product . . . is
biosimilar to the reference product" and "can be expected to produce
the same clinical result as the reference product in any given patient."  Biosimilarity is defined as meaning
"that the biological product is highly similar to the reference product
notwithstanding minor differences in clinically inactive components," and
that "there are no clinically meaningful differences between the biological
product and the reference product in terms of the safety, purity, and potency
of the product."  For
biological products that are administered to an individual more than once, information
must also be provided showing that "the risk in terms of safety or
diminished efficacy of alternating or switching between use of the biological
product and the reference product is not greater than the risk of using the
reference product without such alternation or switch."

With
regard to the issue of data exclusivity, the bill states that a biosimilar
application cannot be approved "until the date that is 12 years after the
date on which the reference product was first licensed," and further, that
a biosimilar application may not be submitted "until the date that is 4
years after the date on which the reference product was first licensed."  The bill also provides an additional 6
months of exclusivity for the use of reference products "in the pediatric
population."

Following introduction, H.R.
3962 was referred to the Committees on Energy and Commerce, Education and
Labor, Ways and Means, Oversight and Government Reform, Budget, Rules, Natural
Resources, and Judiciary, for consideration of the provisions of the bill falling
within the jurisdiction of each of the Committees.

    By
Donald Zuhn —

On
October 23, twelve Senators sent a letter to Sen. Harry Reid (D-NV), asking the
Senate majority leader to "support the establishment of a responsible
pathway for the approval of follow-on biologic treatments, or 'biosimilars,'
that ensures patient safety and includes 12 years of data exclusivity."  The letter, which was signed by Mark
Udall (D-CO), Christopher Bond (R-MO), Ben Nelson (D-NE), Kay Bailey Hutchinson
(R-TX), John Kerry (D-MA), Robert Bennett (R-UT), Thomas Carper (D-DE), Thad
Cochran (R-MS), Barbara Boxer (D-CA), Dianne Feinstein (D-CA), Paul Kirk, Jr.
(D-MA), and Mary Landrieu (D-LA), states that "[t]he bipartisan
vote this past summer by the Health, Education, Labor, and Pension (HELP)
Committee to provide 12 years of data exclusivity for innovator biotechnology
companies will help ensure the twin goals of making life-changing and
life-saving biologic treatments more accessible and affordable, while continuing
to foster the ongoing search for new cures and treatments."

The Senators contend that "lengthy
and costly research and development must be coupled with an adequate period of
data exclusivity for the innovator to ensure the future of new life-saving biotech
discoveries."  Nothing that
"more than 150 patient organizations, research universities, venture
capital groups, and innovators have stated strongly that 12 years of data
exclusivity is crucial for ensuring continued growth and discovery in the
biotech industry," the Senators "urge [the majority leader], this
year, to support the enactment of 12 years of data exclusivity for innovator
biotechnology companies."