Approving generics of polymer-based parenteral long-acting drugs

Generics/Research | Posted 26/02/2021

To assure the safety and the efficacy of drugs, quality and batch-to-batch reproducibility need to be guaranteed. In the case of parenteral long-acting products, the regulatory authorities in the European Union (EU) and the US deviate in their guidance, differences include how to define such products and in vitro release assays.

AIFA updates the Transparency Lists for generics

Generics/General | Posted 26/02/2021

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 15 January 2021 the update of its Transparency Lists (liste di trasparenza).

Adherence improves long-term prognosis and medical costs in Japan

Generics/Research | Posted 19/02/2021

Medical costs and the burden associated with cardiovascular disease are on the rise. In Japan, due to changes in lifestyle and other factors, the number of inpatients with cardiovascular disease and other conditions is increasing at a rate of 10,000 per year.

Anti-competitive strategic patenting by pharmaceutical companies

Generics/Research | Posted 12/02/2021

Drug prices have considerably increased in recent years, affecting healthcare budgets and posing a serious risk to the affordability and accessibility of medicines for society [1]. Various reasons for high drug prices are put forward by pharmaceutical companies, including the complexity of drug discovery and development, as well as the expensive and lengthy regulatory procedures involved [2]. While these reasons may play an important role in this regard, some practices by pharmaceutical companies substantially contribute to this problem.

Biocon and Lupin launch generic tacrolimus capsules in US

Generics/News | Posted 05/02/2021

India-based generics makers Biocon and Lupin have both launched generic tacrolimus capsules in the US.

New generics company to offer low-cost versions of high-cost generics

Generics/General | Posted 29/01/2021

Billionaire Marc Cuban has launched a new generics company – Marc Cuban Cost Plus – which ‘is dedicated to producing low-cost versions of high-cost generic drugs’.

Generics applications under review by EMA – January 2021

Generics/General | Posted 22/01/2021

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].

Perspectives of prescribing practices in public health facilities in Eswatini

Generics/Research | Posted 15/01/2021

Rational medicines use (RMU) is the prescribing/dispensing of good quality medicines to meet individual patient’s clinical needs. Policymakers, managers and frontline providers play critical roles in safeguarding medicine usage thus ensuring their rational use. Therefore, in order to investigate this, researchers carried out a study investigating the perspectives of key health system actors on prescribing practices and factors influencing these in Eswatini [1]. Public sector healthcare service delivery in the region is carried out through health facilities (public sector, not-for-profit faith-based, industrial) and community-based care.

A European pharmaceutical strategy promoting generics and biosimilars

Generics/General | Posted 08/01/2021

The European Commission has adopted a new Pharmaceutical Strategy for Europe [1], as of 25 November 2020.

Familiarity with substitution of prescription generics increases positive attitudes toward OTC generics

Generics/Research | Posted 11/12/2020

Introduction of measures to stimulate increased sale of generics swept over the Nordic countries in the 2000s. In Sweden, in 2002, generics substitution for reimbursed prescription drugs was made mandatory and the switching rates rose over the years to reach almost 100%. Although generics policies seem to be reserved for the prescription drug market [1], a contagion effect has been observed in the market for over-the-counter (OTC) drugs. Soon after the Swedish state monopoly on the sale of pharmaceutical products was terminated and new measures to boost sales of generic prescriptions was put in place in 2009, new generic brands of the top-selling OTC analgesics emerged on the market, all with a lower price compared with previously established brands [2]. Since OTC drugs are usually excluded from pharmaceutical benefit schemes, it is reasonable to expect a demand for cheaper brands when such options exist. Albeit, time has shown that the original brands often hold their position as OTC market leaders.