- Safety & Recalls
- Regulatory Updates
- Drug Coverage
- COPD
- Cardiovascular
- Obstetrics-Gynecology & Women's Health
- Ophthalmology
- Clinical Pharmacology
- Pediatrics
- Urology
- Pharmacy
- Idiopathic Pulmonary Fibrosis
- Diabetes and Endocrinology
- Allergy, Immunology, and ENT
- Musculoskeletal/Rheumatology
- Respiratory
- Psychiatry and Behavioral Health
- Dermatology
- Oncology
FDA unveils guidance for biosimilar development
After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.
After months of anticipation, FDA issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.
The announcement came the same day that FDA officials discussed new user fees for biosimilars and generic drugs at a Congressional hearing. Three separate draft guidances map out the scientific considerations, quality analytical factors and other regulatory issues for bringing to market new therapeutic proteins that are similar, "but not the same" as a reference product.
STEP-WISE APPROVAL PATHWAY
Unlike European regulators, FDA decided not to issue guidances for developing biosimilars in different drug product classes. If a specific issue arises with a specific class, "we may write guidance," explained Rachel Sherman, director, Office of Medical Policy in FDA's Center for Drug Evaluation and Research. But so far, she said, "this has not been seen at the most efficient route."
To avoid redundant and unnecessary animal and clinical testing, FDA will permit sponsors to use a non-US licensed comparator in certain studies, with appropriate bridging data. Most applications, though, will require some additional clinical trials, and Sherman expected that all will need immunogenicity studies.
Once FDA determines that a product is biosimilar, the sponsor can opt to demonstrate interchangeability. That will require additional switching studies to show that changing to the new product does not affect safety and efficacy. Interchangeability is a separate determination, and it's sequential, Sherman emphasized. "It would not look like the generic drug model at all."
FDA expects to be inundated with comments of these proposals and plans a public meeting to hear from stakeholders. Meanwhile, staffers are holding dozens of pre-IND meetings with sponsors and encouraging all prospective biosimilar makers to seek early advice. Nine INDs for biosimilars have been filed so far, and the agency is anticipating a full 351(k) application soon.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
