Generics

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.

Cost savings after switching to generic tacrolimus

Generics/Research | Posted 04/12/2020

The use of narrow therapeutic index generic immunosuppressant in solid organ transplantation is controversial. This is because drugs with a narrow therapeutic index, such as immunosupressants, are defined by a narrow distance between the dosage that induces a desired effect and that dosage which already has a toxic effect [1]. This has led to medical and scientific societies being reluctant to switch to generics of these types of drugs because they think that small pharmacokinetic differences could predispose episodes of acute rejection or of adverse effects derived from toxicities of the product [2, 3].

Equivalent adherence with brand and generic osteoporosis treatments

Generics/Research | Posted 27/11/2020

Osteoporosis patients are just as likely to adhere to a generic bisphosphonate treatment as they are to a brand-name product, reveals a new study published in Scientific Reports [1].

Pfizer sues Aurobindo and Dr Reddy’s over Ibrance (palbociclib) generics

Generics/General | Posted 27/11/2020

US-based pharmaceutical company, Pfizer, has filed petitions in US courts against Aurobindo Pharma and Dr Reddy’s Laboratories.

China prioritizes drug innovation while increasing access to drugs approved abroad

Generics/General | Posted 20/11/2020

China's pharmaceutical industry is undergoing a transformation towards high-quality and innovation-focused development, which has led to an explosion of new drug and clinical trial approvals in recent years.

Teva launches first Truvada and Atripla generics and two digital inhalers

Generics/News | Posted 20/11/2020

On 2 October 2020, Teva Pharmaceuticals announced the launch of the first US Food and Drug Administration (FDA) approved generic versions of Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) tablets for the treatment of HIV-1.

Pharmacokinetics and generic drug switching: a regulators view

Generics/Research | Posted 13/11/2020

Researchers from the Netherlands share their view on the pharmacokinetic aspects of generic drug switching, from a regulatory perspective. They argue that there is no reason to change the current average bioequivalence-based approval pathway for generics [1].