[Ip-health] Engelberg, Kesselheim and Avorn on Market Exclusivity for Biologics, in NEJM

[James Love]

Al Engelberg worked for Henry Waxman in drafting the Waxman-Hatch Act --
25 years ago.  Aaron Kesselheim and Jerry Avorn are members of the
Harvard Medical School faculty.  This is a link to their article in the
New England Journal of Medicine on the legislation being considered by
Congress to create a pathway for generic biologic medicines.

The whole article is worth reading, and is available for free directly
from the NEJM web site.   Below is a link, cite and one paragrah from
the timely article.

Jamie

http://healthcarereform.nejm.org/?p=3D2070

Balancing Innovation, Access, and Profits =E2=80=94 Market Exclusivity for
Biologics
Posted by NEJM =E2=80=A2 October 14th, 2009 =E2=80=A2 Printer-friendly

Alfred B. Engelberg, J.D., Aaron S. Kesselheim, M.D., J.D., M.P.H., and
Jerry Avorn, M.D.

<snip>

Biologics represent one of the most promising frontiers in
pharmacotherapy, but their costs can be substantial, reaching $200,000
or more annually for treatments such as imiglucerase (Cerezyme, Genzyme)
for Gaucher=E2=80=99s disease (see table).1 This past summer, committees in=
 both
the Senate and the House approved bills that would authorize the FDA to
create an approval pathway for follow-on biologic, or =E2=80=9Cbiosimilar,=
=E2=80=9D
products that would guarantee manufacturers 12 years of market
exclusivity for a new biologic agent before any biosimilar product could
be approved, even in the absence of a valid patent. Manufacturers could
also obtain an additional 12-year exclusivity period by making minor
changes to the structure of an approved product, such as those that
could lead to changes in administration schedules (e.g., from weekly to
monthly). Supporters argue that these much longer periods of protection
from competition are fair because the development costs for biologic
products are higher than they are for other medications. However, the
bills fail to recognize the unique characteristics of biologic drugs and
upsets the delicate balance between the interests of consumers and those
of innovators.


--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
Wk: +1.202.332.2670 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.=
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