Sandoz to testify at FDA biosimilars hearing
HOLZKIRCHEN, Germany — The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.
Sandoz, the generics arm of Swiss drug maker Novartis, and a major supplier of biosimilars, said its head of global biopharmaceutical development, Mark McCamish, will testify on what it called the need for a single, science-based regulatory standard that the FDA should apply across all biologics. The FDA released draft guidances in February.
"Sandoz is pleased that the FDA has taken another step toward increasing patient access to affordable, high-quality biologics," McCamish said. "We support the flexibility of the draft guidances and hope that [the] FDA will provide similar science-based, pragmatic approaches in its final guidelines."
In advocating for a single standard, McCamish will note that several originator biologics have undergone manufacturing changes since their commercialization, saying that it creates "highly similar" biologics that overlap with the originator products’ attributes, saying that such a highly similar product should justify abbreviated clinical trial programs, as outlined in the draft guidances.
McCamish also plans to say that biosimilar clinical studies are only confirmatory because advances in biotechnology allow a biosimilar manufacturer to use various means to more efficiently pick up differences between a biosimilar and its reference product than any clinical trial, thus allowing full characterization between the two products. Third, he will address interchangeability between biosimilars and their reference products.
Sandoz currently makes biosimilars mostly for the European market, alongside Teva Pharmaceutical Industries and Hospira. While the healthcare-reform law included a regulatory approval pathway for biosimilars in the United States, so far the only biosimilar available here is Sandoz’s Omnitrope (somatropin [rDNA origin]), a treatment for children with growth hormone deficiencies and a biosimilar of Pfizer’s Genotropin.
Reports: FDA may be close to approving drug for HIV prevention
NEW YORK — The Food and Drug Administration may be close to approving a drug for preventing HIV infection, according to published reports.
The Associated Press reported that the FDA had said Truvada (emtricitabine and tenofovir disoproxil fumarate), made by Gilead Sciences, appeared to be safe and effective for preventing HIV infection when taken daily. An FDA advisory committee will review the drug and decide whether to recommend its approval for pre-exposure prophylaxis, or PrEP.
According to the Centers for Disease Control and Prevention, PrEP, which involves taking antiretroviral drugs daily to lower the chances of HIV infection, has been shown as effective in heterosexual men and women and in men who have sex with men, a term used for men who have sexual relations with other men, but do not necessarily identify as gay or bisexual. The CDC also is conducting a study of whether PrEP works in intravenous drug users.
Seattle Genetics, Millennium start phase-3 trial of Adcetris
BOTHELL, Wash. — Seattle Genetics and Takeda’s cancer drug subsidiary have started a late-stage clinical trial for a lymphoma drug, the companies said Wednesday.
Seattle Genetics and Millennium announced the start of a phase-3 trial of Adcetris (brentuximab vedotin) in patients relapsed cutaneous T-cell lymphoma that expresses the CD30 cell membrane protein. The study will enroll more than 120 patients who will be divided into two groups, one of which will receive Adcetris and another that will receive methotrexate or bexarotene.
"We recognize this is a significant milestone in our efforts to explore the potential of this targeted therapy in other indications," Millennium chief medical officer Karen Ferrante said. "Looking forward, this study may support the potential to supplement therapeutic options for patients, from traditional systemic chemotherapy to Adcetris, a targeted therapy."
The companies also plan to start phase-3 trials of the drug in patients with Hodgkin lymphoma later this year or early next year.