Report: Specialty injectable drugs market worth more than $90 billion by 2014
NEW YORK The value of the market for specialty injectable drugs will top $90 billion by 2014, according to a report by medical technology consulting firm Greystone Research Associates.
The firm based its estimate on an analysis of the eight largest specialty injectable therapeutic segments –– including autoimmune disease, metabolic disease, reproductive health, viral infections and others –– while also examining the relationship between product dosage forms, packaging and revenue growth. The data are included in the report, titled “Injectable Drug Delivery: Drugs, Devices, Targets, Markets and Forecasts.”
“The chronic nature of diseases and conditions in these segments makes repetitive dosing a fact of patient life,” Greystone’s managing director George Perros said. “While efforts to develop drugs in sustained-release formulations for less-frequent dosing have yielded some success, the availability of therapies in safe and simple devices and packages remains an important element of patient acceptance.”
Study questions accuracy of health info shared through social media
WOONSOCKET, R.I. A recent study of diabetes information shared on Facebook raised questions about the accuracy of the information on social media sites and its sources, according to the research sponsored by CVS Caremark.
Harvard University and Brigham and Women’s Hospital conducted the survey as part of CVS Caremark’s previously announced three-year collaboration with the researchers. Researchers evaluated 690 individual postings on wall pages and discussion boards written by 480 unique users. The 15 diabetes-related Facebook sites had an average of 9,289 participants.
"To the best of our knowledge, this is the first study to analyze in detail the quality of the information that people with diabetes are sharing with each other through Facebook," stated William Shrank, senior author of the study. "There are certainly public health benefits that can be garnered from these sites — but patients and doctors need to know it is really the Wild West out there."
The researchers found "tentative support" for the health benefits of social media in the management of chronic disease — evidence of patients sharing valuable insights into their conditions not typically available through traditional medical channels, as well as evidence of community-building where emotional support is abundant. However, 1-in-4 comments on these sites were promotional in nature, generally for non-FDA-approved products.
The researchers also identified numerous incidences of surveys, marketing pitches and efforts to recruit patients for clinical trials where the true identity of the poster could not be confirmed. The results of the study were published online in the Journal of General Internal Medicine.
Additional findings include:
- Amajority of posts (66%) are individuals describing their personal experiences with managing diabetes;
- Nearly one-quarter of the posts (24%) represent sharing of personal information that is unlikely to be shared between patient and doctors, such as individuals discussing carbohydrate management in the setting of alcohol consumption;
- Twenty-nine percent of the posts are by diabetic patients providing emotional support to others grappling with aspects of the disease;
- Thirteen percent of the posts are providing specific feedback to information requests by others in the diabetic community; and
- Twenty-seven percent of the posts feature promotional activity and first-person testimonials around non-FDA-approved products and services.
"Social media is an evolving forum that clearly is attractive to people looking to share information and to find support and strategies for living with chronic diseases," stated Troyen Brennan, EVP and chief medical officer of CVS Caremark. "This study shows the many ways that patients are benefiting from social media networks but is critically important for patients to understand the need for fact-checking."
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.