BIOSIMILARS PROPOSAL WOULD LIMIT ACCESS
Although generic drug industry leaders have been lobbying
Congress extensively for legislation to speed the approval of
biogenerics, the latest bill to address that issue is drawing harsh
criticism from the Generic Pharmaceutical Association (GPhA).
That proposal, the "Pathway Act to Biosimilars" sponsored by
Reps Anna Eshoo (D, CA) and Joe Barton (R, TX), "is a pathway
to the wrong destination for patients in need of safe and affordable
biogenerics," GPhA President and Chief Executive Officer
Kathleen Jaeger said. "At best," the proposed legislation "is a
disappointing distraction that does nothing to advance legislation.
At worst, it's a step backwards that puts brand company
profits before patient needs," she said.
GPhA is particularly opposed to what the association described
as "unwarranted and unprecedented market exclusivity or patent
extension provisions" in the bill. Among other things, the legislation
would grant branded manufacturers of biologics "an unjustifiable
14.5 years of market exclusivity beyond the years companies
already have under their existing patents," a GPhA official said.
SPENDING TO PROMOTE GENERICS PAYS OFF
With branded pharmaceutical companies
spending an estimated $30 billion
to promote their products to prescribers
and patients, government agencies
responsible for holding down health costs
should fight back with "counter-detailing"
to promote the use of less expensive
generic drugs. At least that is the view
expressed by generic industry leaders, as
the Senate Special Committee on Aging
debated such an initiative on Capitol Hill.
Such counter-detailing programs have
already been launched by "several states
to deliver objective educational material
to doctors about affordable treatment
options, including the use of generic
medicines," a generic industry spokesman
said.
Under programs in operation in states
such as Florida, Pennsylvania, and West
Virginia, physicians
are provided
with information
about generics,
diet, and lifestyle changes as
alternatives to medication. According to
one study, the program underway in
Pennsylvania saved that state's taxpayers
about $572,000 a year on heartburn
drugs alone.
DR. REDDY'S ACQUIRES
BASF UNIT
Dr. Reddy's Laboratories recently
announced the acquisition
of BASF's pharmaceutical contract manufacturing business,
a move that includes the relevant business, customer
contracts, related new drug applications, and trademarks, as
well as BASF's manufacturing facility and assets in Shreveport,
Louisiana. This business involves the contract manufacturing of
generic prescription and OTC products for branded and generic
companies in the United States. The facility is designed to
manufacture solid, semisolid, and liquid dosage forms.
"We are excited about this acquisition, as this facility provides
us with a profitable revenue base built on strong customer
relationships with branded and generic companies,"
noted Mark Hartman, president of North America Generics at
Dr. Reddy's. "It also provides us with an additional platform to
further expand our prescription generic and OTC capabilities,
and our general product portfolio as well."
STRONGER PRESENCE IN SPAIN FOR TEVA
A recent study by the Department of Health
and Human Services Office of Inspector
General (OIG) found that the FDA exceeded
the 180-day review requirement for nearly half of Abbreviated
New Drug Applications (ANDAs) for generic drugs in 2006,
and it is recommending that the agency improve its record by
changing the way it prioritizes these applications.
The OIG's June report notes that the FDA's Office of Generic
Drugs generally follows a first-in, first-reviewed policy for ANDAs,
rather than first reviewing clear-cut applications that do not
involve patents or exclusivity issues that complicate the process.
In comments to the draft report, FDA noted that it has
already identified portions of the primary recommendations
and is implementing process improvements that are the same
as or similar to the recommendations.
The full report can be accessed at www.oig.hhs.gov/oei/reports/oei-04-07-00280.pdf.
BIOGENERICS COULD HELP SAVE MEDICARE
Generic drug maker Teva Pharmaceutical
Industries Ltd is increasing its
presence in the European pharmaceutical
market through an agreement to buy
the generic pharmaceutical operations
of Bentley Pharmaceuticals Inc for $360
million.
Exeter, New Hampshire?based Bentley
is a leading marketer of generic drugs in
Spain and also sells to other European
Union countries. Officials at Teva said the
acquisition will give their company a
?platform to capture a leading position in
the fast-growing Spanish generic pharmaceutical
market.? A strategic review conducted
by Teva last year identified Spain
as one of the company?s target markets
for future growth.
Inside the Issue
