BIO, GPhA and Sandoz testify at FDA biosimilars hearing
SILVER SPRING, Md. The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of generic drugs, testified Wednesday at a hearing sponsored by the Food and Drug Administration to collect public and industry input on the implementation of the regulatory approval pathway for follow-on biologics included in the healthcare-reform bill.
Biotechnology Industry Organization EVP health Sara Radcliffe said the regulations should emphasize patient safety and incentives for innovation. During debates over the pathway, BIO was on the side of groups that said the regulations governing follow-on biologics, also known as biosimilars, should include a data exclusivity period of 12 years — meaning that the FDA would have to wait 12 years after a biotech drug has hit the market before approving a follow-on version. The generic drug industry, represented by the Generic Pharmaceutical Association, as well as several consumer and patient advocacy groups, favored a five-year exclusivity period similar to the one used for pharmaceutical drugs.
“BIO supported the passage of legislation to enable the FDA to approve biosimilars,” Radcliffe said in her testimony. “As the FDA considers how best to implement the pathway for approving biosimilars, we call on the agency to make patient safety the top priority while preserving incentives for future biotech innovation.”
Mylan VP and head of global biologics research and development Rasmus Rojkjaer testified on behalf of the GPhA, saying that a science-based approval process is needed to ensure lower costs to patients and warning against legal loopholes that would allow exclusivity periods for biotech drugs to be extended indefinitely.
“GPhA believes the Biologics Price Competition and Innovation Act passed earlier this year as part of national healthcare-reform legislation was a cautious first step toward establishing a regulatory approval process for biogeneric products,” Rojkjaer said.
Meanwhile, Sandoz, the generics division of Swiss drug maker Novartis, emphasized the importance of regulations recognizing biosimilarity, meaning a high degree of similarity between an original biotech drug and a knock-off version as demonstrated through a streamlined clinical trial process; the use of supportive data, such as the use of data on biosimilars from other countries when considering whether to approve them for the U.S. market, as long as the product is produced and marketed under the same standards as the U.S. version; and interchangeability between an original biotech drug and a biosimilar.
Sandoz has marketed biosimilars in Europe for several years, alongside Israel-based Teva Pharmaceutical Industries and U.S.-based Hospira. It also markets the biosimilar human growth hormone Omnitrope (somatropin) in the United States, a biosimilar of Pfizer’s Genotropin, under a special approval obtained from the FDA in 2006.
The Pharmaceutical Research and Manufacturers of America also testified Wednesday, releasing a summary of its testimony to Drug Store News Tuesday.
Medco achieves 10.7% profit growth in Q3
FRANKLIN LAKES, N.J. Pharmacy benefit manager Medco Health Solutions had sales of $16.3 billion, including $2.9 billion from specialty pharmacy operations, the company said Tuesday.
The sales resulted in a profit of $371.5 million, a 10.7% increase over third quarter 2009. Cash flows for the first three quarters of the year were $1.37 billion, a decrease of $1.18 billion compared with last year — the decrease resulting from reductions in inventory. The company expects cash flows for the year as a whole to total $2.4 billion. Earnings per share were 85 cents, which the company called record-breaking for third quarter.
Mail-order prescriptions were 27.3 million, a 7.1% increase over last year, with generic volumes increasing by 15.5%, to 17.1 million. The generic dispensing rate was 71.6%, a 3.9% increase over the same period last year.
NACDS weighs in on FDA priorities, urging simpler med info for patients
ALEXANDRIA, Va. The National Association of Chain Drug Stores is urging federal health officials to adopt a simpler means of communicating drug safety and efficacy information to patients, and to clear the way for an approval pathway for generic versions of biologically engineered drugs.
NACDS made its priorities known in a letter Monday to Margaret Hamburg, commissioner of the Food and Drug Administration. The letter came from Kevin Nicholson, the group’s VP government affairs and public policy.
NACDS, he told Hamburg, strongly endorses FDA efforts to adopt a simpler, single medication information document for patients in order to provide clear, easy-to-understand instructions and warnings about possible side effects, etc., of their prescription medicines. Such a document, Nicholson asserted, provides the “final link in the prescription supply chain,” and should be “standardized with respect to format and content.”
Behind that priority: the need to eliminate confusion and improve patient safety, NACDS agreed. “Today, patients receive several different types of written medication information, developed by different sources that may be duplicative, incomplete or difficult to read and understand,” Nicholson pointed out. “This current system is not adequate to ensure that patients receive essential medication information.”
The NACDS official reminded Hamburg that his group was part of a coalition of pharmacy groups that submitted a citizen petition to the FDA in 2008, urging the agency to require drug suppliers to provide “a concise, plain-language document for patients” when they fill a prescription.
Among the group’s other priorities with the agency: adoption of an abbreviated approval pathway for biogenerics. Nicholson also applauded recent efforts by the FDA’s Center for Drug Evaluation and Research and its director, Janet Woodcock, to address lingering skepticism among “certain sectors of the public” about the therapeutic equivalence of generic drugs.
“We applaud Dr. Woodcock for acknowledging this skepticism and for making its resolution a high priority,” he added.
Nicholson also addressed the issue of safety in the pharmaceutical supply chain, noting that NACDS has long supported state efforts to prevent the entry of adulterated or counterfeit drugs into the distribution pipeline. He urged the FDA to continue its stepped-up efforts to assure the integrity of the drug supply system by pursuing “developing global alliances of regulators, more inspections and updated technology systems to assist the agency with increased workload.
“Our industry has supported state-level legislation requiring enhanced wholesale distributor licensure requirements and chain-of-custody ‘pedigrees’ for drug distributions outside the recognized and sale ‘normal distribution channel,’” Nicholson told Hamburg. To that end, he added, “more than 60% of the states have enacted laws and regulations to strengthen the security for the drug distribution supply chain.”