Generics
Factors influencing the use of trade and generic names
Using trade names for drugs in clinical practice has been shown to increase the use of brand-name drugs. Despite efforts by academic medical centres to teach generic drug names and discourage the use of trade names to reduce bias and contain costs, usage of trade names persists. In order to determine what factors might influence healthcare professionals to prescribe by brand-name or generic name, researchers from Stanford University School of Medicine carried out an analysis of medication pages [1].
Novartis divests dermatology and generic oral solids portfolios and part ways with Alcon
Swiss drugmaker Novartis is to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo and will also part ways with eye care specialist Alcon.
Hospital use of generic drugs increases adoption by community pharmacies
A recent Japanese study reveals that hospital adoption of generic drugs can also promote their use by community pharmacies. The researchers found that hospital adoption of generic drugs increased community pharmacy dispensation by almost 10% in only a year, reducing overall medical costs [1].
Novartis accused of pay-for-delay, while Amgen sues over generic thyroid drug
Novartis is facing a lawsuit for attempts to prevent generic versions of its hypertension treatment Exforge, and Amgen announce it will be suing Accord Healthcare for patent infringement on its thyroid drug Sensipar.
Australia approves first capsule-form Viagra generic
Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) for its sildenafil drug, which is delivered in an oral capsule for treating erectile dysfunction.
FDA significantly increases generic user fees in 2019
The US Food and Drug Administration (FDA) has increased the amount that generics manufacturers will have to pay for large-size operation generic drug applicants by more than US$270,000 for fiscal year (FY) 2019 compared to 2018.
Generic diabetes and cancer drugs pose challenge to Bristol-Myers Squibb and Eli Lilly
Generics manufacturers in Bangladesh and Germany have recently announced the launch of generic versions of Bristol-Myers Squibb’s diabetes treatment Glucophage and Eli Lilly’s lung cancer drug Pemetrexed.
Ulcerative colitis and diabetes generics launched in US
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 9 July 2018 that it had launched generic budesonide extended-release tablets (9 mg) in the US. Then on 25 July 2018, Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical manufacturers, announced that it had launched generic metformin extended-release tablets (500 and 1,000 mg) in the US.
Generics applications under review by EMA – June 2018
Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].
Product recalls increase with increasing generics competition
Generics price competition may lead to relaxed manufacturing standards and ultimately lower quality products, according to a study carried out by researchers from three US universities.
