Generics

Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US

Generics/News | Posted 18/01/2019

India-based generics manufacturer Dr Reddy’s is set to have a busy 2019 with the recent launch of generic omeprazole delayed-release tablets for the treatment of heartburn, and the lifting of a US injunction on its anti-narcotic addiction generic Suboxone (buprenorphine and naloxone).

Sandoz to launch epinephrine in early 2019 at a discount to Mylan and Teva’s generics

Generics/News | Posted 11/01/2019

Sandoz, the generics division of Novartis, will launch Adamis Pharmaceuticals Corp’s EpiPen (epinephrine) generic Symjepi in early 2019. Symjepi received US Food and Drug Administration (FDA) approval of its 0.3 mg pre-filled single dose syringe in June 2017 [1], and for its lower dose version (0.15 mg) in September 2018. Epinephrine injectors are used for the emergency treatment of life-threatening allergic reactions (anaphylaxis) caused by allergens, exercise or unknown triggers. These can include reactions to insect bites or stings, foods, medications, latex or other causes.

FDA approves drug for cancers with specific biomarker

Generics/News | Posted 14/12/2018

The US Food and Drug Administration (FDA) announced on 26 November 2018 that it had approved Vitrakvi (larotrectinib), a treatment for adult and paediatric patients whose cancers have a specific genetic feature (biomarker).

Way cleared in US for Suboxone and Zytiga generics

Generics/General | Posted 07/12/2018

The US Court of Appeals is clearing the way for generics competitors to enter the market. The court has lifted an injunction on Dr Reddy’s Suboxone (buprenorphine/naloxone) generic and upheld a decision to invalidate Johnson & Johnson’s (J&J) patent on its blockbuster prostate cancer drug Zytiga (abiraterone).

Glenmark gains FDA approval for MS and pneumonia generics

Generics/News | Posted 07/12/2018

In November 2018, Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced the approval of generics for the treatment of multiple sclerosis (MS) and pneumonia.

Effectiveness of chronic hepatitis C treatment using direct-acting antivirals: real-life data

Generics/Research | Posted 30/11/2018

Hepatitis is an inflammation of the liver and can be caused by medications, toxins, severe alcohol use and other medical conditions. Hepatitis can also be caused by viruses, most commonly hepatitis A, B and C. Both hepatitis A and B can be dangerous, but there are effective vaccines against both viruses, however, there is no vaccines for hepatitis C [1].

FDA approves more generics in 2018 than any other year

Generics/General | Posted 30/11/2018

The US Food and Drug Administration (FDA) approved 971 generics in 2018, more than in any previous year, according to the Activities Report of the Generic Drug Program (FY 2018).

Apotex having trouble with Competitive Generic Therapy exclusivity

Generics/News | Posted 23/11/2018

In August 2018, the US Food and Drug Administration (FDA) approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution (10% and 20%) [1]. Being the first to receive approval under the CGT designation meant that Apotex was eligible for a 180-day period of marketing exclusivity. However, the company is now having trouble with this exclusivity due to timing issues.

Higher generics use results in higher Medicare Part D star ratings

Generics/Research | Posted 16/11/2018

A study conducted by researchers from Auburn University and IMPAQ International has found that Medicare^# Part D* prescription plans with higher generics use have higher summary star ratings and improved member experience [1].

Generics companies winning the legal battle in the US

Generics/News | Posted 16/11/2018

Litigation in the US is clearing the way for generics competitors to enter the market. The latest cases include Spring Pharmaceuticals suing Retrophin for blocking generics of kidney stone drug Thiola (tiopronin) and the invalidation of Johnson & Johnson’s (J&J) patent on its prostate cancer drug Zytiga (abiraterone acetate).

Ensuring a stable supply of APIs in Japan

Generics/Research | Posted 09/11/2018

A stable supply of active pharmaceutical ingredients (APIs) is indispensable for a stable supply of finished pharmaceutical products (FPPs). It is also indispensable for promoting the use of generics, because API distribution issues can lead to generics shortages. For instance, of the 46 drug shortage problems that arose in FY2013, 21 were associated with API shortages [1]. These shortages can result in a perception among medical staff and patients that generic drugs are unreliable. Therefore, minimizing the risk of API shortage is crucial for promoting the use of generics.

Teva sues FDA for changing ‘first applicant’ definition for generics

Generics/General | Posted 09/11/2018

There is yet another twist in the tale of generics of Allergan’s blockbuster dry eye treatment, Restasis (cyclosporine ophthalmic emulsion). The latest development has Israeli generics giant Teva Pharmaceutical Industries (Teva) suing the US Food and Drug Administration (FDA) for changing its policy on eligibility for 180-day marketing exclusivity for generics.

Brazil to remove backlog for generics

Generics/General | Posted 09/11/2018

Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) announced on 3 October 2018 that it will eliminate a backlog of new and generic drug applications by January 2019.

Individual pathways for development of complex generics

Generics/Research | Posted 02/11/2018

The downside of having clear regulatory standards for approval of pharmaceuticals, according to Rodrigo Cristofoletti from Brazil’s Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), is the overuse of one-size-fits-all (OSFA) approaches [1]. Although such approaches ensure harmonization throughout the regulatory decision-making process, they may not be adequate for all cases, and especially not in the case of complex generics.

FDA proposes standardization of generics standards

Generics/General | Posted 02/11/2018

The US Food and Drug Administration (FDA) announced on 18 October 2018 that it has proposed to the International Council on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) to advance the harmonization of scientific and technical standards for generics.

China approves first ambrisentan generic

Generics/News | Posted 26/10/2018

China’s drug regulator, the China Food and Drug Administration (CFDA, 国家食品药品监督管理局 in simplified Chinese), has approved its first ambrisentan generic.

Platelet reactivity with generic and brand-name clopidogrel

Generics/Research | Posted 19/10/2018

The salt linked to the clopidogrel molecule in generic preparations is suspected to affect its clinical efficacy. However, there is a lack of information about inhibition of platelet reactivity by generic preparations. A study was therefore carried out using both generic and brand-name clopidogrel to compare the platelet reactivity [1].

Teva launches generic tadalafil but delays launch of generic Suboxone

Generics/News | Posted 19/10/2018

Teva Pharmaceutical Industries (Teva) announced in September 2018 that it was launching generic tadalafil but would be delaying the launch of its higher-dose Suboxone (buprenorphine/naloxone) generic.

Free prescriptions do not always increase use of generics

Generics/Research | Posted 12/10/2018

One strategy to increase the use of generics is to offer them free of charge. This strategy presumes that this will shift demand away from expensive brand-name drugs and produce savings for insurers and customers alike. In order to test this theory, researchers from the University of Maryland studied co-payment data from Medicare recipients^# to see if offering zero generic co-pays for oral antidiabetic drugs (OADs) and statins increased generics use among low-income subsidy (LIS) patients with diabetes.

European approval for fluticasone/salmeterol and gefitinib generics

Generics/News | Posted 12/10/2018

Indian generics maker Glenmark Pharmaceuticals (Glenmark) announced on 10 September 2018 that its subsidiary Glenmark Arzneimittel had secured marketing authorization in Germany for its generic fluticasone/salmeterol dry powder inhaler (DPI).

FDA approves first drug via Competitive Generic Therapy pathway

Generics/General | Posted 12/10/2018

The US Food and Drug Administration (FDA) announced on 8 August 2018 that it had approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canada-based Apotex’s potassium chloride oral solution.

Limited distribution networks found to be anticompetitive

Generics/Research | Posted 05/10/2018

Limited distribution networks, whereby a drug manufacturer has a contract with one or a small number of distributors, suppress competition in both the generic and biosimilar drug markets. This leads to high costs for both payers and patients, according to a recent US review [1].

Hospitals launch non-profit generics company

Generics/General | Posted 05/10/2018

Several major hospital groups announced the official launch of their non-profit generics company, Civica Rx, on 6 September 2018. The company has been created in an effort to combat regular shortages and the increasing prices of drugs.

Generic hepatitis drug effective in patients with or without HIV

Generics/Research | Posted 28/09/2018

Over 3% of people with hepatitis C infections also have HIV. A new study conducted in Taiwan shows that generic versions of the hepatitis C treatment Epclusa are equally effective in patients with and without HIV co-infection [1].

FDA approves first EpiPen generic amid shortages

Generics/News | Posted 28/09/2018

The US Food and Drug Administration (FDA) announced on 16 August 2018 that it had approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and paediatric patients.

Factors influencing the use of trade and generic names

Generics/Research | Posted 21/09/2018

Using trade names for drugs in clinical practice has been shown to increase the use of brand-name drugs. Despite efforts by academic medical centres to teach generic drug names and discourage the use of trade names to reduce bias and contain costs, usage of trade names persists. In order to determine what factors might influence healthcare professionals to prescribe by brand-name or generic name, researchers from Stanford University School of Medicine carried out an analysis of medication pages [1].

Novartis divests dermatology and generic oral solids portfolios and part ways with Alcon

Generics/General | Posted 21/09/2018

Swiss drugmaker Novartis is to divest the Sandoz US dermatology business and generic US oral solids portfolio to Aurobindo and will also part ways with eye care specialist Alcon.

Hospital use of generic drugs increases adoption by community pharmacies

Generics/Research | Posted 14/09/2018

A recent Japanese study reveals that hospital adoption of generic drugs can also promote their use by community pharmacies. The researchers found that hospital adoption of generic drugs increased community pharmacy dispensation by almost 10% in only a year, reducing overall medical costs [1].

Novartis accused of pay-for-delay, while Amgen sues over generic thyroid drug

Generics/General | Posted 14/09/2018

Novartis is facing a lawsuit for attempts to prevent generic versions of its hypertension treatment Exforge, and Amgen announce it will be suing Accord Healthcare for patent infringement on its thyroid drug Sensipar.

Australia approves first capsule-form Viagra generic

Generics/News | Posted 14/09/2018

Singapore-based iX Biopharma announced on 6 August 2018 that it had received approval from Australia’s Therapeutic Goods Administration (TGA) for its sildenafil drug, which is delivered in an oral capsule for treating erectile dysfunction.

FDA significantly increases generic user fees in 2019

Generics/General | Posted 07/09/2018

The US Food and Drug Administration (FDA) has increased the amount that generics manufacturers will have to pay for large-size operation generic drug applicants by more than US$270,000 for fiscal year (FY) 2019 compared to 2018.

Generic diabetes and cancer drugs pose challenge to Bristol-Myers Squibb and Eli Lilly

Generics/News | Posted 07/09/2018

Generics manufacturers in Bangladesh and Germany have recently announced the launch of generic versions of Bristol-Myers Squibb’s diabetes treatment Glucophage and Eli Lilly’s lung cancer drug Pemetrexed.

Ulcerative colitis and diabetes generics launched in US

Generics/News | Posted 31/08/2018

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 9 July 2018 that it had launched generic budesonide extended-release tablets (9 mg) in the US. Then on 25 July 2018, Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical manufacturers, announced that it had launched generic metformin extended-release tablets (500 and 1,000 mg) in the US.

Generics applications under review by EMA – June 2018

Generics/General | Posted 24/08/2018

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].

Product recalls increase with increasing generics competition

Generics/Research | Posted 24/08/2018

Generics price competition may lead to relaxed manufacturing standards and ultimately lower quality products, according to a study carried out by researchers from three US universities.

Patient sociodemographics and use of generics

Generics/Research | Posted 20/07/2018

Researchers from the US have found that poorer patients are more likely to use generics [1].