Generics

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.

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].