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

[James Love]

Correction, Al Engelberg worked on the the Waxman-Hatch Act, as counsel
to GPIA the generic industry trade association.  I regret the mistake.

Jamie

On Fri, 2009-10-16 at 16:35 -0400, James Love wrote:
> 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 fo=
r
> 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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