Amgen R&D chief testifies at FDA biosimilar hearing
THOUSAND OAKS, Calif. Amgen’s SVP research and development, Joe Miletich, urged members of a Food and Drug Administration panel to establish approval standards for biosimilars that ensure patient safety and follow a science-based approach.
“Put patients first and sound policy will follow,” Miletich said. “Amgen believes biosimilars have a meaningful role to play in the healthcare system. However, dissimilar — unlike generic drugs — are not identical to the innovative biological products.”
In his testimony, Miletich outlined three key recommendations:
- Use well-designed clinical trials to establish biosimilarity;
- Ensure the product manufacturer and lot number is known for all administered biological; and
- Set scientific and practical criteria for interchangeability.
“The challenge with biosimilars is knowing which structural variations matter clinically and which do not. Many differences probably do not matter, while some differences are important,” Miletich said. “Minor changes in structure, formulation or impurities can have a significant impact on patients that cannot always be anticipated with analytical studies.”
In a company statement, Amgen noted that the experience with biosimilar applications in Europe demonstrated the need for clinical trials. “Approximately half of the biosimilars developed in Europe have had unexpected clinical outcomes at some point in their development. Clinical trials are an essential step in evaluating differences between medicines that analytical and pre-clinical studies indicate are similar. Equally important, we must ensure accountability through accurate tracking and tracing of all biological products,” the company stated.
Survey: Shoppers feel supermarkets are helpful in making healthful choices
ST. PETERSBURG, Fla. As many as 50% of shoppers felt that their supermarket helped them make healthful choices, according a recent Catalina Marketing survey (supported by the Food Marketing Institute) released Monday.
In addition, 36% of shoppers believed their supermarket helped them manage or reduce their risk of specific health concerns. And more than 40% of shoppers were interested in supermarkets providing recipes and information for specific health concerns, health screening services, nutritional counseling and personalized wellness plans.
“We will use this study to make it easier for both manufacturers and retailers to help shoppers make healthy, nutritious choices in every aisle of the store,” stated Sharon Glass, Catalina Marketing’s group VP health, wellness and beauty. “It uncovers what shoppers really want and how to design programs or services that best align with their needs. Making smart nutritional choices can notably improve overall health and how we feel each day.”
According to the findings, shoppers want a combination of convenience, cost, taste and messaging that will motivate them to replace fast-food meals with healthier options. “Our members want an integrated approach to creating comprehensive health-and-wellness programs,” stated Cathy Polley, VP health and wellness and executive director of the FMI Foundation at the Food Marketing Institute. “Catalina Marketing’s blueprint can help them make health and wellness a reality in their supermarket.”
Other findings include:
- 38% of shoppers reported that their grocery store provides information on foods and beverages that can help manage their personal health concerns;
- 25% believed that store employees are knowledgeable about nutrition. But less than one-third of respondents felt that supermarket employees were knowledgeable enough to provide assistance about nutrition, vitamins, nutritional supplements and over-the-counter health remedies;
- 77% believed healthy food is expensive, and more than 80% said coupons for healthy products encourage healthy shopping;
- 59% felt that healthy foods and beverages generally taste good. Fast-food fans are the least likely to agree that healthy options generally taste good;
- 69% of shoppers were interested in having their store stock freshly prepared, healthy meals, and 64% were interested in programs that recommend healthier options for the products they generally buy through messages printed at the checkout or website tools; and
- 51% of respondents with children find it hard to plan healthy meals.
The online study surveyed more than 2,500 male and female adults across the United States older than 21 years of age with primary responsibility for the grocery-shopping in their homes. The study provided guidance on how the industry can best help shoppers make positive choices in nutrition and lifestyle management.
Research shows retail clinics can replace up to 1-in-4 emergency room visits
CONSHOHOCKEN, Pa. Up to 1-in-4 emergency room visits could take place at a retail-based health clinic or urgent care center, saving potentially $4.4 billion annually, according to new research published in the September issue of Health Affairs.
Furthermore, the research found that such retail clinics as Take Care Clinics have been shown to save patients $279 to $460 per visit compared with emergency room costs.
A second study published in Health Affairs found that 42% of the 354 million annual visits for acute care are made to patients’ personal physicians.
"This research reaffirms the need for alternative sites of care to help ease the pressure of overcrowded emergency departments and long wait times that are often necessary to get an appointment with patients’ primary care providers," stated Hal Rosenbluth, Walgreens SVP, president of Walgreens health-and-wellness division and co-founder of Take Care Health Systems. "The fact that $4.4 billion could be saved by utilizing options like Take Care Clinics and other retail and urgent care clinics is a wake-up call to patients, employers and health plans that money spent on health care can be better allocated to help ease the pressure on an already burdened system."
The Health Affairs article looked at data provided by retail clinics and urgent care centers in 2007 and compared it with emergency department visit data in 2006. The researchers used a list of health conditions that commonly are treated at retail clinics and urgent care facilities to determine the number of visits that could have been treated at alternative sites.
"We are playing an integral role in healthcare reform by providing an entry into the healthcare system for many Americans through both our retail clinics as well as our worksite health centers," stated Sandy Ryan, chief nurse practitioner for Take Care Health Systems. "By offering quality health care where people live and work, Take Care Health Systems is improving the lives of our patients, connecting them within the existing healthcare community and reducing the burden on the healthcare system as a whole. This trend could continue as health plans and employers explore ways to encourage patients to utilize retail clinics more frequently instead of making trips to the emergency department."