Generics

Patent challenges in the SADC region

Generics/Research | Posted 30/08/2019

High pharmaceutical prices restrict access to essential medicines. New medicines are often patent protected which sustains prices well above the cost of production. This problem was particularly apparent during the HIV/AIDS crisis in the late 1990s. At this time, 40 million people were believed to be infected with HIV in the developing world and only one in a thousand had access to the required antiretroviral medicines (ARVs). This situation led to conflicts regarding patents for HIV medicines, only a few years after the establishment of the World Trade Organization (WTO) and the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. TRIPS established international standards to protect intellectual property, including a 20-year patent protection for medicines.

Generic irbesartan is safe and effective, shows phase IV trial

Generics/Research | Posted 23/08/2019

Generic versions of the anti-hypertensive irbesartan are equally effective as their branded counterparts, finds a phase IV study conducted in Korea. The study also found that irbesartan is less effective in patients with a high body mass index (BMI) or a history of anti-hypertensive use, suggesting more intensive treatment may be needed in some patients [1].

FDA approves Farxiga generic

Generics/News | Posted 23/08/2019

The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s diabetes medicine Farxiga (dapagliflozin). Patent issues, however, must be resolved before FDA grants full approval.

Prices for infectious disease treatments and how to reduce them

Generics/Research | Posted 16/08/2019

A recent review from Harvard Medical School explores the factors fuelling high drug prices in the US, suggesting several ways to avoid exorbitant pricing, including increasing clinician awareness of healthcare costs [1].

Certara technology achieves first FDA virtual bioequivalence approval for a complex generic drug

Generics/News | Posted 09/08/2019

On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation technology successfully demonstrated the bioequivalence of a complex generic drug. This has led to US Food and Drug Administration (FDA) approval of the drug on the agency’s abbreviated new drug application (ANDA) pathway.

Generics applications under review by EMA – July 2019

Generics/General | Posted 02/08/2019

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].

Generic Drug User Fee Act is a benefit to the Indian pharmaceutical industry, study finds

Generics/Research | Posted 26/07/2019

The Generic Drug User Fee Act (GDUFA) has had positive effects on generics manufacturers in India, providing increased return on investment and encouraging compliance with US regulation, recent analysis suggests [1].

Gilead’s Truvada will face generics competition in 2020

Generics/General | Posted 19/07/2019

Gilead Sciences’ HIV blockbuster Truvada will face generics competition in the US in 2020, a year earlier than expected.

EMA approves two generics for fungal infections

Generics/News | Posted 19/07/2019

On 29 May 2019, the European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for two new generics for the treatment and prevention of fungal infections, Posaconazole Accord and Posaconazole AHCL.

FDA approval for Unichem Lab’s hydrochloride medicines and Teva’s nasal spray to treat opioid overdose

Generics/News | Posted 21/06/2019

The US Food and Drug Administration (FDA) has granted Unichem Laboratories a tentative abbreviated new drug approval (ANDA) for their generic hydrochloride tablets, and has approved the first generic naloxone hydrochloride nasal spray, manufactured by Teva Pharmaceuticals (Teva).

Pharmacy benefit managers use spread pricing to increase profits in Michigan

Generics/General | Posted 07/06/2019

A report released in April 2019 raises new questions about the role of Pharmacy Benefit Managers (PBMs) in Michigan, specifically their use of spread pricing to increase profits at the expense of pharmacists, taxpayers and patients.

Teva launches generic testosterone gel and overactive bladder treatment in the US

Generics/News | Posted 31/05/2019

In April 2019, Israeli generics giant Teva Pharmaceutical Industries (Teva) announced the launch of generic versions of AndroGel (testosterone gel) 1.62% CIII and VESIcare (solifenacin succinate) tablets, 5 mg and 10 mg, in the US.

Adherence to generic versus brand-name statins and associated clinical and economic outcomes

Generics/Research | Posted 24/05/2019

Despite evidence supporting the efficacy of statins for the treatment and prevention of cardiovascular disease, a lack of adherence to statin treatment continues to be a major problem. Sicras-Mainar and colleagues investigated real-world treatment persistence and medical possession for generic versus brand-name statins used in routine clinical practice, and assessed associated clinical and economic outcomes [1].

Multi-state lawsuit alleges widespread generic price fixing in the US

Generics/General | Posted 17/05/2019

A sweeping lawsuit filed on 10 May 2019 by over 40 US states alleges that a number of major drug companies conspired to inflate the prices of generic drugs by as much as 1,000%.

EMA approves hypertension and Parkinson’s generics

Generics/News | Posted 17/05/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended granting marketing authorization for hypertension and Parkinson’s generics.

Mixed beliefs about generics among patients in a Malaysian hospital

Generics/Research | Posted 03/05/2019

The Malaysian Government is heavily subsidizing public healthcare expenditure in order to provide access to health care for all citizens. In 2017, total healthcare expenditure in the country was approximately 9.4% of the annual budget. In order to overcome the increasing cost of health care, the government has implemented a National Generic Medicine Policy in 2006 to promote healthier competition in medicine pricing and to make medicines more affordable to the general public. After 10 years of policy implementation, authors from the Ministry of Health Malaysia assess patients' beliefs about generics.

US Court rejects Teva’s lawsuit over generic Restasis

Generics/General | Posted 26/04/2019

The US District Court for the District of Columbia has discarded lawsuits from generics giant Teva Pharmaceutical Industries (Teva) regarding its first-to-file exclusivity rights on a generic version of the blockbuster dry eye drug Restasis (cyclosporine).

Stada launches generic Exforge following patent revocation

Generics/News | Posted 19/04/2019

German generics producer Stada Arzneimittel announced on 20 March 2019 that it is set to launch a generic version of the antihypertensive Exforge (amlodipine/valsartan combination), following the revocation of a Novartis European patent.

FDA releases statement on generic drug quality

Generics/General | Posted 12/04/2019

A statement released by the US Food and Drug Administration (FDA) responds to recent press reports of quality issues and outlines the Agency’s ongoing efforts to maintain the quality of generic drugs manufactured both in the US and overseas.

Spotlight on the role of pharmacy benefit managers in the fight against rising drug prices

Generics/General | Posted 05/04/2019

High prices of prescriptions have become a major issue for patients and politicians in the US. In addition to scrutiny of pharmaceutical companies, the role of distributors, insurance companies and middlemen including pharmacy benefit managers (PBMs) is now attracting attention.

Market evolution of new drug formulations

Generics/Research | Posted 01/04/2019

Brand-name drug manufacturers sometimes create modified versions of their approved drugs which can include new strengths, dosage forms, or delivery routes. This product modification can meaningfully increase patient treatment options; however, some cases have come under scrutiny as they do not offer any clear therapeutic advantages. This second practice is a form of ‘product hopping’, a method used by manufacturers to prolong revenue streams related to market exclusivity. Complementary strategies such as product discontinuation can augment the impact of product hopping.

Factors associated with increased side effects and lower perceived efficacy when switching to a generic

Generics/Research | Posted 22/03/2019

In 2017, the New Zealand Pharmaceutical Management Agency (PHARMAC) changed the funded version of the antidepressant venlafaxine from Efexor XR (the branded originator) or Arrow-Venlafaxine XR (a generic version) to a new generic, Enlafax XR. MacKrill and Petrie examined differences in preferences and perceptions between patients switched from the originator branded venlafaxine to the new generic, and those switched from the old generic version [1]. Specifically, they investigated the factors associated with preference for branded medicines, side effects reported following switching and efficacy ratings of the new generic.

FDA approves generics from Amneal and Dr Reddy’s, and Natco submits ANDA

Generics/News | Posted 22/03/2019

In January 2019, the US Food and Drug Administration (FDA) approved Amneal Pharmaceutical’s (Amneal) generic Exelon patch and Dr Reddy’s Laboratories (Dr Reddy’s) Tosymra nasal spray, and Natco Pharma submitted an abbreviated new drug application (ANDA) to FDA for its Ibrutinab tablets.

Escalating prices of generic drugs in the US

Generics/Research | Posted 15/03/2019

Generic prescription drug prices have been escalating rapidly in the US. In 2014, generic drug prices increased by 38% on average. Public outcry has led to a flurry of legislative proposals, and two federal bills were introduced in 2017 to improve price transparency and identify drugs exhibiting outlier ‘price spikes’, however, both remain unenacted. In the first three months of 2018, 53 drug pricing transparency bills were initiated in 23 state legislatures.

Pilot procurement scheme in China cuts drug prices

Generics/General | Posted 08/03/2019

The Chinese pharmaceutical market, which is dominated by domestic manufacturers, is the second largest in the world in terms of value after the US. In a bid to lower drug prices for patients and reduce costs for manufacturers, the Chinese State Medical Insurance Administration introduced a national pilot scheme for tendering with minimum procurement quantities in a recent round of reforms across 11 major cities. If proven successful, the scheme is expected to be rolled out across China.

The 700-dollar vitamin: excessive generics prices in the US

Generics/Research | Posted 01/03/2019

Authors from Johns Hopkins University School of Medicine discuss excessive prices for generics in the US, using vitamin K₁ as an example [1].

USP action plan for generics and FDA new innovation office

Generics/General | Posted 01/03/2019

The US Pharmacopeia (USP) has issued an action plan to promote generics and the US Food and Drug Administration (FDA) has announced the creation of a new office for drug innovation.

Mylan launches Advair generic at 70% discount

Generics/News | Posted 01/03/2019

US-based drugmaker Mylan announced on 12 February 2019 the launch of Wixela Inhub (fluticasone/salmeterol inhalation powder, USP) at a list price 70% less than the originator product, GlaxoSmithKline’s (GSK) best-selling asthma drug Advair Diskus.

Impact of generic reference pricing on candesartan and rosuvastatin use in South Africa

Generics/Research | Posted 15/02/2019

Researchers from South Africa and The Netherlands investigated the effect that generics and generic reference pricing has on candesartan and rosuvastatin use in South Africa [1].

Zydus gets FDA approval for skin, heart and acid reflux generics

Generics/News | Posted 15/02/2019

Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market betamethasone dipropionate cream, 0.05%, a generic version of Diprolene^®AF, and generic amlodipine and atorvastatin tablets (Caduet^®). It has also received tentative FDA approval to market generic esomeprazole magnesium delayed-release capsules (Nexium^®). This brings the total approvals of the Zydus group to 247, and it has so far filed over 330 abbreviated new drug applications (ANDAs) since the filing process commenced in the 2003‒2004 financial year.