Generics

Difficult-to-make drugs meet US quality standards

Generics/Research | Posted 14/05/2021

Difficult-to-make prescription pharmaceuticals marketed in the US consistently meet quality standards even when manufactured outside the country, finds a study published in JAMA Network Open [1].

New in vitro–in vivo simulations predict generic bioequivalence

Generics/Research | Posted 07/05/2021

If we can predict the outcome of bioequivalence studies in the generic drug development process, we can save time and money. Now, a new in vitro–in vivo simulation (IVIVS) approach to predict the in vivo outcome of these studies, published in Materials [1], has been developed by researchers National and Kapodistrian University of Athens.

EMA recommends approval of abiraterone and ioflupane (123I) generics

Generics/News | Posted 07/05/2021

The European Medicines Agency’s (EMA) Committee for Medical Products for Human Use (CHMP) recommended granting marketing authorizations for two generic medicinal products at its April 2021 meeting.

Generics in India

Generics/General | Posted 30/04/2021

India is the world’s largest generic drugs producer, yet the generics market within the country is relatively small. In a recent article [1], Sajid Sheikh and Gunjan Deshpande of the Maharashtra National Law University, Mumbai, explore the current status of generics in India.

Tentative US approval for Symbicort generic

Generics/News | Posted 23/04/2021

On 8 March 2021, Viatris Inc and Kindeva Drug Delivery LP announced that the US Food and Drug Administration (FDA) has granted the tentative approval of their generic version of Symbicort® (budesonide/formoterol).

US$1.2 FDA contract for generic drug computational tool

Generics/General | Posted 16/04/2021

The US Food and Drug Administration (FDA) Office of Generic Drugs (ODG) has awarded a US$1.2 million contract to support the development of a computational tool that will aid generic drug research.

Dispensing branded drugs costs Medicare over a billion dollars

Generics/Research | Posted 09/04/2021

Branded drugs dispensed instead of generics at the request of physicians and patients have incurred annual costs of over US$1 billion to the Medicare programme. and US$270 million to patients, reveals a study published in JAMA Network Open [1].

Technological approaches to drug repurposing for cancer treatment

Generics/Research | Posted 02/04/2021

Cancer is one of the leading causes of death in the world today, causing nearly 10 million deaths in 2018 alone. Despite extensive research into new treatments, when these eventually reach the market, they are often very expensive. The strategy of drug repurposing is being applied to identify already approved drug products as potential cancer therapies. This can bring new cancer treatments to patients faster and at a lower price. A review, published in Signal Transduction and Targeted Therapy [1], summarizes approaches used for drug repurposing and discusses the main barriers to uptake.

EMA recommends approval of abiraterone and thiotepa generics

Generics/News | Posted 02/04/2021

In January and February 2021, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) held meetings that led to positive opinions towards the recommendation for approval of two generics, Abiraterone Accord (abiraterone) and Thiotepa Riemser (thiotepa).

Teva and Sandoz launch new generics

Generics/News | Posted 26/03/2021

In early 2021, Teva Pharmaceuticals announced the US launch of generic versions of NuvaRing® and AZOPT®. During the same period, Sandoz launched its version of Firazyr.

EMA recommends approval of fourth COVID-19 vaccine

Generics/News | Posted 19/03/2021

11 March 2021 saw the European Medicines Agency (EMA) recommended granting a conditional marketing authorisation for the fourth COVID-19 vaccine. After a thorough evaluation, EMA’s Committee for Medicinal Products for Human Use (CHMP) concluded that data on the Janssen vaccine were robust and met the criteria for efficacy, safety and quality.

Debate about generic versus brand-name drugs for glaucoma

Generics/Research | Posted 19/03/2021

Glaucoma is a chronic, largely asymptomatic disease that often needs lifelong treatment. The choice of drugs is extremely important as the cost of drugs; side effects and efficacy often affect compliance and adherence to therapy. For a given class of drug, there are three options including brand-name drugs, generics and branded generics. Brand-name drugs are costlier compared to generics and branded generics because they are originator molecules developed by a company after many years of research and come into the market with a patent. Whereas branded generics are produced by a different company once the patent of the originator company expires. Moreover, competition amongst different companies to make the similar formulation of branded generics further reduces the cost.

Posaconazole, silodosin and droxidopa generics from Lupin and Sandoz

Generics/News | Posted 12/03/2021

Early 2021 saw the launch of two generic versions of posaconazole in Canada and the US. In Canada, the first generic version of the drug was launched by pharmaceutical manufacturer Sandoz Canada on 26 January 2021, along with a generic version of silodosin. These launches were followed by the launch of Lupin’s generic posaconazole in the US in mid-February 2021. During the same period, Lupin also announced the US approval of its generic droxidopa capsules [3].

The role of authorized generics in improving access to medicines

Generics/Research | Posted 05/03/2021

In recent years, many authorized generic drug products have been launched by pharmaceutical companies at lower prices than their brand-name originators. A recent viewpoint, published in JAMA Internal Medicine [1], discusses the ways that authorized generics are launched in the US. It also considers whether these products improve lower costs and access to medicines.

Opportunities for generics with Korean patent expires in 2021

Generics/General | Posted 05/03/2021

As part of ongoing action to improve the quality of generics and ensure an efficient and competitive generics market, the Korean Ministry of Food and Drug Safety (MFDS) announced that 158 patents for pharmaceutical products will expire in 2021.

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.

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].

EMA recommends approval of Lenalidomide Mylan

Generics/News | Posted 13/11/2020

The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 October 2020 that it recommends granting marketing authorization for the generic medicine Lenalidomide Mylan (lenalidomide).

COVID-19 vaccine progress and FDA approvals for Zydus Cadila

Generics/News | Posted 13/11/2020

India-based generics company, Zydus Cadila, has had many advancements with product development and approval between August and October 2020. In August, the company announced that its plasmid DNA vaccine to prevent COVID-19 (ZyCoV-D) was found to be safe and well tolerated in the phase I clinical trial. Following this, phase II trials of the vaccine started on 6 August 2020. In October, Zydus Cadila had a number of products approved by the US Food and Drug Administration (FDA) and was launching a forglyn pressurized metered-dose inhaler (pMDI) to treat patients with chronic obstructive pulmonary disease (COPD) in India.

Brazil sees a COVID vaccine setback but treatment advancement

Generics/General | Posted 06/11/2020

In Brazil’s quest to tackle the COVID-19 pandemic, there has been a volunteer death in a potential vaccine trial, but a potential treatment option has emerged. Brazil has the second number of COVID-19 deaths, with over 159,033 deaths recorded up to end of October 2020.

FDA approves Glenmark and Cipla generics

Generics/News | Posted 30/10/2020

Glenmark Pharmaceuticals and Cipla Limited have announced that they have received US food and Drug Administration (FDA) approval to market their generic drug products in the US. Both companies have received approval to market dimethyl fumarate delayed-release (DR) capsules and Glenmark also received approval to market Sirolimus tablets.

Reforms to health policy needed in Europe

Generics/General | Posted 23/10/2020

The President of Medicines for Europe has made four key recommendations for European Union (EU) pharmaceutical policy, while the Irish Pharmacy Union (IPU) says reforms to the health service could save Ireland millions of euros.