[Ip-health] BNA: House Members Receive Feedback on Creating Follow-On Biologics Pathway

[Mike Palmedo]

http://pubs.bna.com/ip/bna/PLP.NSF/eh/a0b6r0c6n7

House Members Receive Feedback On Creating Follow-on Biologics Pathway

BNA Pharmaceutical Law and Industry Report
Volume 6 Number 25
Friday, June 20, 2008
ISSN 1542-9555

The House Energy and Commerce Committee June 17 released responses to
its questionnaire soliciting feedback from drug companies and other
interested parties on creating establish a pathway to allow the Food and
Drug Administration to approve biosimilar products, also called generic
biologic drugs or follow-on biologics.

Rep. Frank Pallone, Jr. (D-N.J.), chairman of the Energy and Commerce
Committee Subcommittee on Health, and Rep. Nathan Deal (R-Ga.), ranking
member of the Subcommittee on Health, sent the letter to stakeholders in
April. "We hope these responses will better inform our efforts to craft
legislation that can achieve consensus among the Members," Pallone and
Deal said in a press release. "We are fully committed to ensuring that
FDA has the authority to approve safe, affordable bio-similar products
in an appropriate and timely fashion."

The responses came from biotech companies, generic drug companies,
government agencies, and consumer groups and differed on such matters as
whether a generic biologic should be interchangeable with the brand
product and the period of data exclusivity allotted to innovators.

In its May 2 response, the Biotechnology Industry Organization (BIO)
said any legislation should "recognize that biological products are
fundamentally different from traditional drugs in their complexity,
development and production processes, and that follow-on biologics are
not generic drugs."

BIO said a pathway must address both how to ensure patient safety and
how to maintain incentives that encourage continued investment and
innovation, including strong protections for intellectual property rights.

"BIO strongly supports the creation of a follow-on biologics pathway and
believes that Congress should pass the right bill as soon as possible
this year," BIO President and Chief Executive Officer Jim Greenwood said.

Biotech drug company Amgen Inc. said that while an abbreviated approval
pathway for biosimilar products should be developed, that pathway must
be tailored to address the unique characteristics of biotechnology.

Among other things, Amgen said that biosimilar products should not be
substituted for the brand product at the pharmacy level without the
consent of a physician. Because of their nature, biosimilars will not be
identical to the brand product and only a physician can determine what
is appropriate for a particular patient, the company said.

Amgen also said the "future of biotech medicines depends upon continued
incentives for innovation" and any legislation should include a
mechanism for the resolution of patent disputes before a biosimilar
comes on the market. The company also suggested that innovators receive
14 years of data exclusivity.

Meanwhile, AARP said it believes that legislation should allow FDA to
approve biogenerics as interchangeable to the brand product.

"Not all comparable biologics will be able to demonstrate
interchangeability, but the FDA should be able to grant such designation
for those who can so demonstrate," David P. Sloane, AARP senior vice
president of government relations and advertising, said. "Again, the FDA
should be granted the flexibility to determine--as science dictates--in
which cases a designation of interchangeability is appropriate."

FTC Input

The Federal Trade Commission said that legislation should "ensure that
generic biologics do not create another opportunity for brand and
generic companies to enter into anticompetitive patent settlements."

FTC also said that Congress should disconnect the FDA approval process
for generic biologics from patent litigation, and ensure there is no
opportunity for brand companies to lengthen their exclusivity periods
through "insignificant changes to a branded biologic or through
excessive procedural delays."

Three biogeneric bills have been introduced in the House that differ on
issues such as data exclusivity and interchangeability. The most recent
bill (H.R. 6529) was introduced March 13 by Rep. Anna G. Eshoo
(D-Calif.) and Joe Barton (R-Texas), the ranking Republican on the
Energy and Commerce Committee (6 PLIR 330, 3/21/08 a0b6e9c2r2 ).

Rep. Henry A. Waxman (D-Calif.), along with Pallone, introduced a bill
(H.R. 1308) in February 2007. Also pending is a bill from Rep. Jay
Inslee (D-Wash.), introduced in April 2007 (H.R. 1956).

In the Senate, a biogenerics bill (S. 1695) was approved unanimously by
the Senate Health Education Labor and Pensions Committee in June 2007 (5
PLIR 674, 6/29/07 a0b4t4e0z2 ).

A Growing Market

Illustrating what is at stake in the biotech follow-on debate, health
information company IMS Health issued a report June 18 finding that
global prescription sales of biotech drugs increased 12.5 percent in
2007, to more than $75 billion. IMS pointed out that the global biotech
market grew at nearly double the rate of the global pharmaceutical
market, which increased by 6.4 percent in 2007.

An IMS press release said that follow-on biologics "are expected to have
only a modest impact on the market over the next 5-10 years." For
example, IMS said that the introduction of biosimilar epoeitin alfa (an
anti-anemia drug) in European markets in 2007, "has had a negligible
impact in the market to date." In addition, the release said that a
biosimilar omnitrope, introduced in 2006, has captured less than 1
percent of the somatropic human growth hormone market. The Food and Drug
Administration approved Sandoz's omnitrope in 2006, not as a generic
product but as "therapeutically equivalent" to Pfizer Inc.'s Genotropin
(4 PLIR 656, 6/2/06 a0b2v9f4a3 ).

However, IMS said the prospect of follow-ons/biosimilars represents "a
shift in the biotech marketplace that over time will bring emerging
competition from biosimilars following the loss of exclusivity of
original products."

Pallone and Deal's letter is available at
http://energycommerce.house.gov/Press_110/110-ltr.040308.list.Biologic%20ltr.pdf.
The responses are available at
http://energycommerce.house.gov/Press_110/040308.FOB.Responses.shtml.

--
Mike Palmedo
Research Coordinator
Program on Information Justice and Intellectual Property
American University, Washington College of Law
4910 Massachutsetts Ave., NW Washington, DC 20016
T - 202-274-4442 | F 202-274-0659
mpalmedo@wcl.american.edu