Generics

FDA approves first EpiPen generic amid shortages

Generics/News | Posted 28/09/2018

The US Food and Drug Administration (FDA) announced on 16 August 2018 that it had approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and paediatric patients.

Factors influencing the use of trade and generic names

Generics/Research | Posted 21/09/2018

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

Generics/General | Posted 21/09/2018

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

Generics/Research | Posted 14/09/2018

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

Generics/General | Posted 14/09/2018

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

Generics/News | Posted 14/09/2018

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

Generics/General | Posted 07/09/2018

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/News | Posted 07/09/2018

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

Generics/News | Posted 31/08/2018

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

Generics/General | Posted 24/08/2018

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/Research | Posted 24/08/2018

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.

Patient sociodemographics and use of generics

Generics/Research | Posted 20/07/2018

Researchers from the US have found that poorer patients are more likely to use generics [1].

MSF challenges hepatitis C patent in China

Generics/General | Posted 20/07/2018

Médecins Sans Frontières (MSF, Doctors Without Borders) announced on 19 June 2018 that it was challenging the ‘unmerited’ patent in China for hepatitis C medicine velpatasvir from Gilead Sciences (Gilead). The health advocacy group said that ‘affordable generic versions from China could save millions of people’s lives’.

Generic cancer pain relief launched in Japan

Generics/News | Posted 20/07/2018

Japan-based Daiichi Sankyo announced on 15 June 2018 that it had launched a generic version of cancer pain relief Fentos Tape (fentanyl citrate tape).

Generic sofosbuvir and daclatasvir bioequivalent to originators

Generics/Research | Posted 13/07/2018

With the aim of eliminating hepatitis C (HCV) by 2030, some originator pharmaceutical companies have granted voluntary licences to generics companies to mass produce the direct-acting antivirals (DAAs) sofosbuvir and daclatasvir at low cost. In order to achieve this, generics makers need to demonstrate bioequivalent pharmacokinetics for their DAAs, compared to the originators. Therefore, researchers carried out a study to determine whether generics of sofosbuvir and daclatasvir had bioequivalent pharmacokinetics to the originators [1].

FDA approves first Suboxone generics for opioid dependence

Generics/News | Posted 13/07/2018

The US Food and Drug Administration (FDA) announced on 14 June 2018 that it had approved the first generics of Suboxone (buprenorphine/naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. The generics have been developed by Indian generics maker Dr Reddy’s Laboratories (Dr Reddy’s) and US-based drugmaker Mylan.