By
Donald Zuhn —

Affordable Health Care
for America Act Placed on Senate Legislative Calendar

The
Affordable Health Care for America Act (H.R. 3962), which was passed by the
House of Representatives on November 7th by a narrow five-vote margin (220-215),
has now been placed on the Senate Legislative Calendar.  The 1,990-page bill includes a section
(§ 2575) providing for the establishment of a licensure pathway for biosimilar
biological products, which precludes a biosimilar application from being
approved "until the date that is 12 years after the date on which the
reference product was first licensed," and offers an additional 6 months
of exclusivity for the use of reference products "in the pediatric population"
(see "House Health Care Bill
Includes Biosimilar Licensure Pathway").

Health Care Bill
Introduced in the Senate

On
November 18th, two days after H.R. 3962 was placed on the Senate Legislative
Calendar, Senate Majority Leader Harry Reid (D-NV) unveiled the Senate's own
health care bill, the Patient Protection and Affordable Care Act (H.R. 3590).  At first glance, the bill appears to be
unrelated to health care, stating instead that it "amend[s] the Internal
Revenue Code of 1986 to modify the first-time homebuyers credit in the case of
members of the Armed Forces and certain other Federal employees, and for other
purposes."  However, a check
of THOMAS indicates that the H.R. 3590 "is the vehicle for the version of
health care reform that will be debated in the Senate."  Like H.R. 3962, the 2,074-page Senate
bill contains a section (§ 7002) providing for an approval pathway for
biosimilar biological products. 
Also like H.R. 3962, the Senate bill precludes a biosimilar application
from being approved "until the date that is 12 years after the date on
which the reference product was first licensed."  In addition, the Senate bill, like H.R. 3962, offers an additional
6 months of exclusivity for the use of reference products "in the
pediatric population."

AP Reports on Senate Health
Care Bill

An
Associated Press report ("Reid
health bill helps chiropractors, drugmakers")
regarding the Senate bill states that it "extends the
protection some brand-name manufacturers would get from generic competitors,"
as "Reid's bill would add another six months of protection for drugmakers
who also test those products for use by children."  Because the bill passed in the House
contains an the same pediatric exclusivity provision, it is perhaps unfair to
suggest that the pediatric exclusivity provision of Senator Reid's bill has somehow extended innovator exclusivity even
further.

CCPM Comments on Senate
Health Care Bill

The
Coalition for a Competitive Pharmaceutical Market (CCPM),
which recently released a statement "appealing to Congress to fix the
excessive 12-year market exclusivity and ever-greening provisions for biologics
or drop it altogether" (see
"Follow-on Biologics News Briefs – No. 9"),
released a short statement
after Senator Reid unveiled H.R. 3590, in which the CCPM "voic[ed] serious
concern in response to the extension of biologics exclusivity included in The
Patient Protection and Affordable Care Act (H.R.3590)."  In particular, the group states that
"[d]espite numerous economic studies, widespread media attention, patient
outcry, and the support of the Administration for a more balanced approach, the
Senate Health Care Reform bill went in the opposite direction by adding
additional exclusivity to the already unacceptable 12 years of market
exclusivity for brand products."  The CCPM statement does not specify exactly how the Senate bill goes "in the opposite direction by adding
additional exclusivity."

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).

GPhA Says Senate Bill
"Gratuitously Extends Biologic Monopolies"

In
a statement
released by the Generic Pharmaceutical Association (GPhA) on November 19th,
GPhA President and CEO Kathleen Jaeger writes that "[j]ust when you think
the pro-BIO and PhRMA provisions in health care reform couldn't get any more
favorable for them, the Senate health care reform bill has further disappointed
consumers by adding additional monopoly protection to expensive biologic medicines,"
adding that "[r]egardless of the motivation, the biologic provision in
this bill takes the already egregious and unwarranted 12 years of exclusivity
and extends it."  With regard to how the bill extends the 12-year exclusivity period, Ms. Jaeger
alludes to the Senate's failure "to close down a major loophole known as
'evergreening.'"  She also states that "[i]n the name of true health care
reform, it is incumbent upon Congress to strip the anti-consumer biologic provision
out of health care reform." 
The GPhA represents manufacturers and distributors of finished generic
pharmaceuticals and bulk active pharmaceutical chemicals.

Boston Globe Criticizes
12-Year Exclusivity Period; Prompts Response

An
Op-Ed article in last week's Boston Globe
commends Congress for trying "to open the door for approval of generic
versions of drugs known as biologics," but concludes that "after
intensive lobbying by the biotech industry, the measures that are emerging from
Congress grant too many years of exclusivity to the original makers"
("Biotech bills give drugmakers too many years of exclusivity").  The Globe
argues that the 12-year exclusivity period in current House and Senate
bills is "too long, more than double the five years of protection from
competition guaranteed for conventional drugs."

The
Globe Op-Ed, however, appears to disregard
the differences in developmental costs and time between small molecule
therapeutics and biologics (see
"Amgen VP Makes Case for Longer Exclusivity Period in Follow-on Biologics
Legislation").  Instead, the article contends that
"competition from generics is not likely to erode the ability of the
original biotech manufacturers to continue reaping profits," because
"[t]here are onerous technical barriers to making so-called biogenerics,
unlike generic versions of conventional medications, so companies that invent
original drugs are likely to retain market share despite the new competition."

In
support of this argument, the Globe points
to an article published in the New
England Journal of Medicine last month, which contends that a 5-year
exclusivity period would be sufficient because follow-on biologics have led to
biologic price reductions of between 25-30% (as compared with innovator small
molecule price reductions of up to 80%) in Europe (see "NEJM Authors Say Five Years of Data Exclusivity Would Be
Sufficient").  The Globe
parts ways with the NEJM article on
an appropriate exclusivity period, stating that "[i]n clearing the path
for generic alternatives to expensive biologics, Congress should enact a
shorter window of market exclusivity than 12 years, but more than the five
years afforded to simpler, conventional drugs," and adding that "[a]
protection period that falls directly in between these extremes would strike a
balance between encouraging companies to make biologic drugs and making them
affordable."

In
response
to the Op-Ed article, Massachusetts Biotechnology Council (MassBio)
President Robert Coughlin argued that the Globe's
"editorial misleadingly compared the 12 years of data exclusivity in the
biosimilars legislation with the five-year provision for traditional
pharmaceuticals," contending that "[t]his apples-to-oranges
comparison overlooks the fact that biologics cannot achieve the same kind of
patent protection as pharmaceuticals."  Mr. Coughlin also noted that:

Data
exclusivity does not prevent competition. 
Companies can bring competitive products to market during the
exclusivity period, provided they conduct their own safety and efficacy
research.  They cannot piggyback on
an innovator’s proprietary data to obtain FDA approval until the exclusivity
period ends.  That’s simply fair.

According
to the MassBio website, the group represents
more than 600 biotechnology companies, universities, academic institutions and
others dedicated to advancing cutting edge research.