BIOSIMILARS PROPOSAL WOULD LIMIT ACCESS
Although generic drug industry leaders have been lobbyingCongress extensively for legislation to speed the approval ofbiogenerics, the latest bill to address that issue is drawing harshcriticism from the Generic Pharmaceutical Association (GPhA).
That proposal, the "Pathway Act to Biosimilars" sponsored byReps Anna Eshoo (D, CA) and Joe Barton (R, TX), "is a pathwayto the wrong destination for patients in need of safe and affordablebiogenerics," GPhA President and Chief Executive OfficerKathleen Jaeger said. "At best," the proposed legislation "is adisappointing distraction that does nothing to advance legislation.At worst, it's a step backwards that puts brand companyprofits before patient needs," she said.
GPhA is particularly opposed to what the association describedas "unwarranted and unprecedented market exclusivity or patentextension provisions" in the bill. Among other things, the legislationwould grant branded manufacturers of biologics "an unjustifiable14.5 years of market exclusivity beyond the years companiesalready have under their existing patents," a GPhA official said.
SPENDING TO PROMOTE GENERICS PAYS OFF
With branded pharmaceutical companiesspending an estimated $30 billionto promote their products to prescribersand patients, government agenciesresponsible for holding down health costsshould fight back with "counter-detailing"to promote the use of less expensivegeneric drugs. At least that is the viewexpressed by generic industry leaders, asthe Senate Special Committee on Agingdebated such an initiative on Capitol Hill.
Such counter-detailing programs havealready been launched by "several statesto deliver objective educational materialto doctors about affordable treatmentoptions, including the use of genericmedicines," a generic industry spokesmansaid.
Under programs in operation in statessuch as Florida, Pennsylvania, and WestVirginia, physiciansare providedwith informationabout generics,diet, and lifestyle changes asalternatives to medication. According toone study, the program underway inPennsylvania saved that state's taxpayersabout $572,000 a year on heartburndrugs alone.
DR. REDDY'S ACQUIRESBASF UNIT
Dr. Reddy's Laboratories recentlyannounced the acquisitionof BASF's pharmaceutical contract manufacturing business,a move that includes the relevant business, customercontracts, related new drug applications, and trademarks, aswell as BASF's manufacturing facility and assets in Shreveport,Louisiana. This business involves the contract manufacturing ofgeneric prescription and OTC products for branded and genericcompanies in the United States. The facility is designed tomanufacture solid, semisolid, and liquid dosage forms.
"We are excited about this acquisition, as this facility providesus with a profitable revenue base built on strong customerrelationships with branded and generic companies,"noted Mark Hartman, president of North America Generics atDr. Reddy's. "It also provides us with an additional platform tofurther 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 Healthand Human Services Office of InspectorGeneral (OIG) found that the FDA exceededthe 180-day review requirement for nearly half of AbbreviatedNew Drug Applications (ANDAs) for generic drugs in 2006,and it is recommending that the agency improve its record bychanging the way it prioritizes these applications.
The OIG's June report notes that the FDA's Office of GenericDrugs generally follows a first-in, first-reviewed policy for ANDAs,rather than first reviewing clear-cut applications that do notinvolve patents or exclusivity issues that complicate the process.
In comments to the draft report, FDA noted that it hasalready identified portions of the primary recommendationsand is implementing process improvements that are the sameas 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 PharmaceuticalIndustries Ltd is increasing itspresence in the European pharmaceuticalmarket through an agreement to buythe generic pharmaceutical operationsof Bentley Pharmaceuticals Inc for $360million.
Exeter, New Hampshire?based Bentleyis a leading marketer of generic drugs inSpain and also sells to other EuropeanUnion countries. Officials at Teva said theacquisition will give their company a?platform to capture a leading position inthe fast-growing Spanish generic pharmaceuticalmarket.? A strategic review conductedby Teva last year identified Spainas one of the company?s target marketsfor future growth.