Sandoz, GPhA weigh in on follow-on biologics provision
NEW YORK Many people have a lot to say about the recently passed healthcare bill, but generic drug makers have focused their attention on one area in particular.
Sandoz, the generics arm of Swiss drug maker Novartis, said it welcomed the bill’s inclusion of an abbreviated regulatory approval pathway for follow-on biologics, known variously as “biosimilars” and “biogenerics.”
Sandoz compared the creation of a biosimilars pathway with the Hatch-Waxman Act of 1984, which created an abbreviated pathway for generic pharmaceutical drugs, and expressed confidence in the FDA and eagerness to work with the agency.
But the pathway has its detractors as well, including the Generic Pharmaceutical Association, an industry trade group for the generic drug industry. The bill grants biotech companies a 12-year period of data exclusivity, meaning that the FDA would have to wait until a biotech drug had been on the market for that long before it could accept for review an application for a biosimilar version; the 12-year figure is based on studies that have indicated it takes around 14 years from the time a branded pharmaceutical drug is launched before the generic becomes available. The data exclusivity period for pharmaceutical drugs is five years.
The issue of exclusivity periods has been a thorny one. For most in the generic drug industry, particularly the GPhA, five years would give biotech companies ample time to recoup their investments while also allowing faster access to cheaper alternatives to biotech drugs for patients, and GPhA president and CEO Kathleen Jaeger responded to the healthcare bill’s passage by saying it would provide a pathway for biosimilars “in name only.” Meanwhile, the biotech industry has said that longer exclusivity periods are necessary because biologics cost more to develop and manufacture than pharmaceuticals; also, biotech companies say, the unique properties of biotech drugs would theoretically allow a biosimilar manufacturer to circumvent an innovator’s patents, thus making patent protection with five years’ exclusivity ineffective.
GSK offers free vaccines to uninsured adults
RESEARCH TRIANGLE PARK, N.C. GlaxoSmithKline is offering its vaccines free of charge to low-income adults, the British drug maker announced Monday.
The GSK Vaccines Access Program offers adult vaccines for diseases such as hepatitis, tetanus and human papillomavirus for adults ages 19 years and older who lack health insurance coverage for vaccines.
“Vaccines are one of the most effective ways we can prevent and fight disease, and subsequently drive down the cost of health care in the United States,” GSK president for North America Pharmaceuticals Deirdre Connelly said. “Unfortunately, vaccines are severely underutilized by American adults.”
Children up through the age of 18 years are eligible to receive free vaccines under a separate program, Vaccines for Children, which receives federal funding.
NBA Cares takes vaccination awareness program to Detroit
DETROIT The charitable arm of the NBA is expanding its education program about adolescent vaccinations to Detroit.
Detroit Pistons forward Jonas Jerebko and NBA Legend Bob Lanier teamed up with NBA Cares and the Society for Adolescent Medicine to bring Vaccines for Teens to the Metro Detroit community. Vaccines for Teens is a national multimedia campaign designed to educate teens and their parents about the importance of vaccination against serious and potentially life-threatening diseases.
To tip off the campaign locally, Jerebko and Lanier appeared at the Arts and Technology Academy in Pontiac, Mich., to urge parents of preteens and teens to discuss adolescent vaccinations with their family physicians.
Teens are at risk for influenza disease, both seasonal and the influenza A (H1N1) virus, as well as for other serious infectious diseases such as meningococcal disease (including meningitis) and whooping cough (pertussis). The basketball superstar and local community leaders agree it is more important than ever to help protect preteens and teens in the Metro Detroit area from the potentially life-threatening complications of these diseases.
“Vaccination can help teens grow into healthy adults, and is beneficial for the students at Arts and Technology Academy of Pontiac and for teens throughout the Metro Detroit area,” said Jerebko. “In basketball, the best offense is a good defense, and the same holds true for protecting teen health.”