[Ip-health] Health Canada Issues Draft Guidance For Biologics and details re new US Biologics bill

[Sarah Rimmington]

Health Canada Issues Draft Guidance For Biologics
March 24th, 2008 8:27 am By Ed Silverman
http://www.pharmalot.com/2008/03/health-canada-issues-draft-guidance-for-bi=
ologics/

As the US grapples with a pathway for biogenerics, Health Canada has
beat the FDA to the punch and issued a draft guidance. The agency
recently posted on its website requirements for manufacturers and says
it could approve products under existing regulations until laws are
amended to include the new approval pathway, FDA News reports.

If finalized, a so-called subsequent-entry biologic would have to be
similar to a previously approved biologic, relying in part on publicly
available safety and efficacy data. Interchangeability and
substitutability would not be automatic, but would be decided on a
case-by-case basis, according to the draft guidance. Health Canada says
it plans to publish additional guidance documents on specific product
classes, FDA News continues.

A subsequent-entry biologic would not automatically be approved for all
the same indications as the reference product, and data would be
required to support each indication in most cases. A meeting is
scheduled for May. This is Health Canada=92s draft guidance [go to the web
link for the article to download it]. In the US, a bill was recently
introduced in Congress that would create a pathway for FDA approval.

----

You can see details about the new House Biologics bill, in a previous
pharmalot article:

Biosimilar Bill Is Introduced To Hoots & Hollers
March 14th, 2008 8:50 pm By Ed Silverman
http://www.pharmalot.com/2008/03/biosimilar-bill-is-introduced-to-hoots-hol=
lers/

As promised last month, Anna Eshoo, a Democrat from California -
specifically, the region where many biotechs and venture capitalists are
based - has now introduced legislation that would create a so-called
pathway for FDA approval while offering brand-name companies 12 years of
exclusivity, plus an extra two years for a medically significant
innovation. That adds up to, yes, 14 years. (This is the bill and this
is the summary).

Not surprisingly, the BIO trade group was ecstatic in its praise for
Eshoo and Joe Barton, a Texas Republican who joined her in sponsoring
the bill, which calls for studies to demonstrate safety and efficacy;
requires the FDA to create a mechanism to determine whether products are
interchangeable and also requires the agency to issue guidances for
biosimilar approvals.

=93Some special interests publicly say they want to delay follow-ons
legislation until next year or beyond,=94 says BIO ceo Jim Greenwood in a
statement. =93We urge Congress to pass the right bill as soon as possible.
It is time all parties work together to place patient needs before
political gamesmanship. The time is now to pass a pro-patient,
pro-innovation, pro-science follow-on biologics bill.=94

Conversely, the Generic Pharmaceutical Association was distressed and
argued the lengthy exclusivity provision will deny patients access to
lower-cost meds for years. =93=91The Pathway for Biosimilars Act=92 is a
pathway to the wrong destination for patients in need of safe and
affordable biogenerics. This new bill, at best, is a disappointing
distraction that does nothing to advance legislation. At worst, it=92s a
step backwards that puts brand company profits before patient needs,=94
says GPHA ceo Kathleen Jaeger, in a statement. =93For a pathway to work,
it must ensure patient access. Unfortunately, this new proposal creates
a pathway filled with needless roadblocks to access.

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/