PhRMA to testify at FDA hearing
WASHINGTON The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent and scientific regulatory structure; and enable innovation and competition when creating regulations governing follow-on biologics, according to testimony released in advance of an FDA hearing by a drug lobbying group.
The Pharmaceutical Research and Manufacturers of America will testify Wednesday at the FDA’s public hearing on the implementation of the approval pathway for follow-on biologics that was included in the healthcare-reform bill. PhRMA’s testimony also included statements about biosimilarity, interchangeability and other topics.
The hearing began Tuesday morning and includes testimony from numerous interested organizations and companies.
The healthcare-reform bill, passed late last year, includes provisions for a regulatory approval pathway for follow-on biologics, also known as biosimilars, knock-off versions of biotech drugs. The bill allows for 12 years of data exclusivity for innovator biologics, meaning that the FDA would have to wait that long before it could grant approval to biosimilar versions — compared with generic pharmaceutical drugs, for which the exclusivity period is five years.
Also unlike generic drugs, it is difficult and often impossible to characterize, or fully map out, the chemical structures of biotech drugs and the mechanisms by which they work, hence the use of the term “biosimilars.” What this means is that subtle differences in biosimilars resulting from genetic differences in the cells used to create them could cause them to affect the body differently from the originals on which they’re based, thus requiring a more complex approval process that may include clinical trials.
FDA approves new treatment for bacterial infections
NEW YORK The Food and Drug Administration has approved a new treatment for bacterial infections made by Forest Labs, Forest said.
The drug maker announced the approval of Teflaro (ceftaroline fosamil) for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection, also known as ABSSSI, caused by bacteria that include methicillin-resistant Staphylococcus aureaus.
“Forest recognizes the enormous burden of disease associated with community-acquired bacterial pneumonia and [ABSSSI], and we are extremely pleased to see that our first product in this category has obtained approval for both of these disease indications,” said Dirk Thye, president of Forest subsidiary Cerexa.
Forest said it plans to make Teflaro available to wholesalers by January.
Adding to its clout in specialty care, McKesson wins bid for U.S. Oncology
SAN FRANCISCO In a big boost to its growing specialty pharmacy operation, drug-distribution and health services giant McKesson today revealed it has bought U.S. Oncology for $2.16 billion in cash and assumed debt.
Both companies said the deal should close by the end of McKesson’s third quarter on Dec. 31. When finalized, said company officials, it will merge McKesson’s strengths in healthcare services and information technology with U.S. Oncology’s expertise in clinical care, along with what it calls “the largest community-based cancer treatment and research network in America.” The combined organization, said McKesson, “will focus on providing a comprehensive offering of solutions for the oncology industry, one of the fastest-growing segments in healthcare.”
Following the merger, McKesson’s combined Specialty Care Solutions business will be led by U.S. Oncology CEO Bruce Broussard, who will report to McKesson executive VP and group president Paul Julian. The new operation will be based in The Woodlands, Texas, with additional offices in McKesson’s home city of San Francisco and other locations throughout the country.
It will deliver, in McKesson’s words, “a best-in-class oncology program, clinical tools, guidelines and care pathways that will create a leader in evidence-based medicine backed by a deep team of clinical experts.”
The new organization will initially serve a base of some 3,000 oncologists, spurring what the company said will be accelerated investments in integrated systems and clinical programs to boost productivity, efficient delivery of care and improved patient outcomes.
“For U.S. Oncology customers, they’re going to get a world-class distributor,” said McKesson chairman and CEO John Hammergren. “And for McKesson customers, they’re going to get a world-class oncology operations company.”
Hammergren called the acquisition “the next step in our involvement in oncology.”
“Clearly U.S. Oncology has a significant amount of technology, and has the world’s leading physicians using the world’s state-of-the-art thinking around clinical care,” he added. “They’ve driven efficiency in their practices, but perhaps more importantly, they’ve been leading the practice of health care from an oncology perspective.”
McKesson’s acquisition of the cancer-care giant will accelerate the consolidation of the specialty pharmacy market, predicted Adam Fein, PhD, founder and president of Pembroke Consulting. “After the U.S. Oncology acquisition, McKesson and AmerisourceBergen will now represent almost 80% of all specialty pharmaceutical distribution, which is the primary channel to market for office or clinic-based physicians,” Fein noted today.