Generics
Proposed rebates will hit patients, not drug companies
Attempts by US Congress to halt the rise in generics prices with new rebates payable by drugmakers has received a stinging rebuff from the Generic Pharmaceutical Association (GPhA).
Dr Reddy’s faces temporary sales ban on generic esomeprazole
A US court has temporarily banned Dr Reddy’s Laboratories from selling its generic version of AstraZeneca’s heartburn drug Nexium (esomeprazole) in the US over allegations of trademark infringement.
Safety monitoring of drug interchangeability
When a brand-name drug is going off patent protection, pharmaceutical or generics companies may file an abbreviated new drug application (ANDA) for approval of a generic drug. As indicated by the US Food and Drug Administration (FDA), two drug products are claimed to be bioequivalent (BE) if the 90% confidence interval (CI) for the geometric mean ratio is totally within the bioequivalent limits of (80%, 125%) based on log-transformed data [1, 2] and an approved generic drug can be used as a substitute for the brand-name drug. FDA, however, does not indicate that approved generics of the same brand-name drug can be used interchangeably. Assume a patient switches the generic drug from BE 125% to BE 80% or from BE 80% to BE 125%, the change of the drug concentration in blood are both dramatic. As more generics become available in the marketplace, it is a concern whether the approved generics are safe and can be used interchangeably.
US politicians form Affordable Drug Pricing Task Force
On 4 November 2015, democratic members of the House Committee on Oversight & Government Reform launched the Affordable Drug Pricing Task Force, which its members say will bring about ‘meaningful action to combat the skyrocketing costs of pharmaceuticals’.
FDA evaluation of residual solvents in generics
Differences between generics and their reference product in terms of inactive ingredients, e.g. residual solvents, are allowed if applicants provide information demonstrating that these differences do not affect the safety or efficacy of the proposed drug product. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by formulation differences between generic and originator drugs [1].
Tentative FDA approval for chemotherapy generic
Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015.
Prescribing generics for chronic musculoskeletal pain
The use of generics has become an issue of concern, both in public health and economical terms. Nevertheless, parallel to an ever-stronger advocacy for their use, various sources of information have reported patients’ concerns regarding substitution. Using a qualitative interview study, researchers from Geneva University Hospitals and the University of Geneva investigated the personal definitions and understanding of generics in patients suffering from non-specific chronic musculoskeletal pain, to elucidate the reasons that might explain why patients are confident or reluctant to take generics [1].
FDA making progress with ANDA backlog
Despite an increase in the volume of abbreviated new drug application (ANDA) submissions, Type II API Drug Master Files (DMFs), supplements and amendments during financial year (FY)2014, the US Food and Drug Administration (FDA) has acted on more pending submissions compared to FY2013.
Sandoz launches authorized fluvastatin generic in US
Sandoz, the generics division of Novartis, announced on 16 October 2015 the launch of an authorized generic version of Lescol (fluvastatin) tablets.
FDA evaluation of impurities in generics
Although generics may differ from their reference product in terms of inactive ingredients, which includes impurities, such compounds in generics, especially genotoxic impurities, are an area of increasing concern for the pharmaceutical and regulatory world. Authors from the Office of Generic Drugs at the US Food and Drug Administration (FDA) highlight general toxicology concerns caused by such formulation differences between generic and originator drugs [1].
