Generics

Medicare Part D favours generics over brand-name drugs

Generics/Research | Posted 23/10/2020

A recent assessment of Medicare Part D [1] finds that insurance plans favour generic drugs over innovator products. Fewer than 1% of plans covered only the brand-name version of a drug in 2019.

Sun Pharma launches Ilumya in Japan and favipiravir in India

Generics/News | Posted 16/10/2020

Sun Pharmaceutical Industries Inc (Sun Pharma) announced that their innovative biopharmaceutical product, Ilumya (tildrakizumab), will be launched in Japan. As a producer of generics, rather than biologicals, this is an important milestone for the company. This launch joins Sun Pharma’s August 2020 launch of favipiravir for treatment of COVID-19 patients at a very economic price in India.

Structural reforms are required to make Japan’s healthcare system sustainable

Generics/General | Posted 09/10/2020

Japan’s healthcare system provides universal coverage and high-quality healthcare delivery. With relatively minor changes for nearly six decades, it has kept the country remarkably healthy. However, a recent study has highlighted that significant changes may be necessary to maintain long-term sustainability.

Out-of-pocket spending caps cut patient spending by a third

Generics/Research | Posted 02/10/2020

Out-of-pocket spending caps on specialty drugs in the US have reduced spending by 32% for some patients, finds a new study of almost 30,000 specialty drug users [1].

EMA recommends approval for arsenic trioxide and fampridine generics

Generics/News | Posted 25/09/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting marketing authorization for two generic medicines: arsenic trioxide medac (arsenic trioxide) and Fampridine Accord (fampridine).

The benefits of tracking generic drug quality

Generics/General | Posted 18/09/2020

Resources such as the US Food and Drug Administration’s (FDA) Sentinel Initiative should be used to their full potential in order to monitor the quality of generic drugs, suggests a recently published research letter [1].

Mylan launches first generic of Tecfidera in the US

Generics/News | Posted 11/09/2020

On 19 August 2020, Mylan announced the launch of the first US Food and Drug Administration (FDA) approved generic of Biogen's multiple sclerosis (MS) treatment Tecfidera (dimethyl fumarate).

Evaluating reasons for US low generics substitution rates

Generics/Research | Posted 11/09/2020

The uptake of generic drug products in the US has not met expectations despite their widespread availability and relatively low cost. A team of researchers based at Johns Hopkins University in the US, have now investigated the reasons for generics utilization and substitution across therapeutic classes. They reveal marked variation in reasons, with women less likely to substitute for generics, those using mail order pharmacies less likely to substitute, and state specific laws having little influence.

Lupin’s generic diabetes drug approved and asthma drug launched in US

Generics/News | Posted 04/09/2020

In August 2020, India-based generics maker Lupin announced that it has received approval from the US health regulator to market a generic diabetes drug in America. Following previous US Food and Drug Administration (FDA) approval, it has also now launched generic tablets for the treatment of asthma in the US market.

Generics substitution in Finland: a pharmacy dispenser perspective

Generics/Research | Posted 28/08/2020

In Finland, mandatory generic drug substitution was adopted in 2003 [1]. This is overseen by pharmaceutical staff who give advice to patients and decide which drug products they should receive. A recent study by Ranio et al. assessed the content of patient counselling about interchangeable medicines and generics substitution in Finnish community pharmacies [2].

Two additions to the South Korean generics market

Generics/News | Posted 28/08/2020

In South Korea, a generic drug for the treatment of breast cancer and generic versions of Pfizer’s popular smoking cessation drug, Champix, are soon to become available. These additions to the South Korean market are likely to help it reach the US$20 billion that it is expected to reach in 2020 [1]. This recent leap in its pharmaceutical market size has been spurred on by significant government investments in generics and the fact that many originator drugs lose their patents in 2020, opening the market to generics.

Study reveals link between socioeconomic status and brand-name prescriptions

Generics/Research | Posted 31/07/2020

A link between socioeconomic status and the prescription of brand-name drugs in the US, has been revealed by a team of researchers based at Brown University [1].

Indian generics makers begin to dispatch remdesivir

Generics/News | Posted 24/07/2020

Generic drugmakers Hetero and Cipla are among the first Indian manufacturers to dispatch a generic version of the investigational COVID-19 treatment remdesivir, which was originally developed by Gilead Sciences.

Generics applications under review by EMA – July 2020

Generics/General | Posted 17/07/2020

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 27 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].

Cost savings from the use of generic Gleevec (imatinib)

Generics/Research | Posted 17/07/2020

Modelling of the cost savings from the use of generic Gleevec (imatinib) in the US finds that US payers saved US$2.5 billion in years 1 and 2 following patent expiry. Projected savings in years 3 to 5 exceed US$12 billion, even without step-edit formulary management [1].

Cost-effectiveness of generic dabigatran

Generics/Research | Posted 10/07/2020

Since the enactment of Hatch-Waxman Act in 1984, use of generics has grown substantially in the US. Generics now account for nearly nine out of 10 prescriptions and are considered a cost-containment solution for escalating healthcare expenditures [1]. However, several factors may influence the use of generics including, but not limited to, the perception of the safety and effectiveness of these products [2]. The US Food and Drug Administration’s (FDA) standard of bioequivalence requires similar pharmacokinetic (PK) profiles of generic versus reference drug products with the assumption of similar pharmacodynamic (PD) effect. However, several instances related to generics substitution and treatment failures have led to concern particularly for drugs with narrow therapeutic indices and in therapeutic areas with severe effectiveness and safety outcomes.

Generics of apixaban and chlorzoxazone approved in EU and US

Generics/News | Posted 03/07/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended a generic version of the anticoagulant medicine apixaban. Meanwhile in the US, the Food and Drug Administration (FDA) has approved a generic version of the muscle relaxant chlorzoxazone.

Differences in originator and generic drug labels: impact on patient safety

Generics/Research | Posted 26/06/2020

The labels for established generics and their originators differ. Especially when it comes to safety messaging, these differences could have a fatal or life-threatening impact on patients, according to researchers from Switzerland [1].

Generics substitution in Finland: a pharmacy customer perspective

Generics/Research | Posted 19/06/2020

Generics offer less expensive alternatives to brand-name drugs. However, they must be accepted by patients to increase uptake and reduce healthcare cost. Finland adopted generics substitution in 2003. Then, in 2009, this was supplemented with a reference price system. A recent survey [1] has shown that the price of medicine is key for Finnish pharmacy customers.

HIV drug Kaletra appears on Russian black market

Generics/General | Posted 12/06/2020

There are several reports of a black market in Russia emerging for the HIV drug Kaletra, following claims that it can be used to treat COVID-19.

Aurobindo Pharma receives FDA approval for three generics

Generics/News | Posted 12/06/2020

India-based generics maker Aurobindo Pharma (Aurobindo) has received three approvals from the US Food and Drug Administration (FDA) in recent months, including for its generic versions of guaifenesin, fluoxetine and – via partner company Eugia Pharma – methotrexate.

US policy to combat high-priced generics

Generics/Research | Posted 29/05/2020

The cost of prescription drugs is a concern in the US. Drug prices typically decline once a generic drug is approved due to market competition. However, in recent years generics prices have risen and there have been shortages. The US Food and Drug Administration (FDA) has taken action to reduce prices and increase generics competition. It is hoped that this will increase access to medicines across the country.

COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative

Generics/News | Posted 22/05/2020

Gilead Sciences has signed licensing agreements with five generics manufacturers based in India and Pakistan to increase production of its experimental COVID-19 drug remdesivir.

Why does the US face high-priced generics and drug shortages?

Generics/Research | Posted 15/05/2020

Healthcare budgets in the US are under strain and the cost of prescription drugs is a continuous concern. Generic drugs offer cheaper alternatives to brand-name products due to competition. However, in recent years generics prices have risen in the US and there have been shortages of products.

FDA approves Proventil and Daraprim generics

Generics/News | Posted 08/05/2020

The US Food and Drug Administration (FDA) has approved the first generic version of a commonly used inhaler, marketed as Proventil, and the anti-parasitic Daraprim, which has previously been the subject of a price gouging scandal.

CMS proposes new measures to rate generic usage

Generics/General | Posted 04/05/2020

The Centers for Medicare & Medicaid Services (CMS) is actively working to promote competition and lower costs for drugs, according to a statement released in February 2020, which also details new measures of generics usage to help calculate a plan’s star rating.

Science, outreach, development: US Generics Drugs Office reaches new highs in 2019

Generics/General | Posted 24/04/2020

The US Food and Drug Administration (FDA) Office of Generic Drugs 2019 Annual report gave updates on the number of generics approvals in 2019. These remained high at 1,014 [1-3]. The report also discussed the progress of the FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme [4], and information about the achievements of the Office of Generic Drugs (OGD) in terms of research proposals, outreach activities and international development.

Comparison of economic loss between generics and patented drugs in Indonesia

Generics/Research | Posted 17/04/2020

Poor management of the drug inventory in hospitals can be caused by stagnant and stock-out conditions, which might lead to economic loss. In order to investigate this phenomenon, researchers from Indonesia compared the economic loss between generics and patented drugs in stagnant and stock-out conditions at the Surabaya Islamic Hospital [1].

Improving the pathway for generics approval in the US: 2019 update

Generics/General | Posted 17/04/2020

The US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 annual report in February 2020. This gave updates on the number of generics approvals in 2019 which reached 1,014. It also gave information on the progress of FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme in 2019.

Generics approvals remain high in US in 2019

Generics/General | Posted 10/04/2020

In February 2020, the US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 Annual report which highlighted the year’s key achievements. The report stated that in 2019, the Office of Generic Drugs (OGD) facilitated 1,014 generic drug final and tentative approvals. This is slightly lower than the 1,021 approvals of 2018 but remains high enough to make a positive contribution to the FDA’s generic drug programme.

Generics outreach programmes should target high income groups

Generics/Research | Posted 27/03/2020

Patients with lower incomes are more likely to use generic drugs, finds a literature review from Auburn University, Alabama, USA [1].

FDA approves lung cancer and anticoagulant generics

Generics/News | Posted 20/03/2020

The US Food and Drug Administration (FDA) has issued a final approval for a generic version of Alimta (pemetrexed) and two new generics of Eliquis (apixaban).

Pharmacopeial standards may increase generics competition

Generics/Research | Posted 13/03/2020

Pharmacopeias, which contain descriptions of drug preparations, are critical for ensuring the safety of drug products. A study from Johns Hopkins University has now shown that pharmacopeial standards may also increase generics competition [1].

Delayed entry of buprenorphine generics cost NHS England GBP 0.5 million

Generics/Research | Posted 06/03/2020

A market analysis has shown that lack of competition for generic buprenorphinepatches meant the National Health Service (NHS) in England lost savings. The analysis estimates that if all generic drug products entered the market at the same time, the NHS could have saved GBP 0.5 million more over a six-month period [1].

Chinese company makes copy of patented coronavirus treatment remdesivir

Generics/News | Posted 28/02/2020

China’s BrightGene has successfully produced remdesivir, an experimental treatment for coronavirus, however, patents for the drug are currently held by the American company Gilead.

Survey reveals attitudes to unauthorized hepatitis C generics

Generics/Research | Posted 28/02/2020

A survey of physicians, pharmacists, patients and other professionals in Switzerland has shown that, although most people think unauthorized generics are lower quality than their corresponding brand, they do support their import for those in need [1].