Generics
Dubai’s LIFEPharma signs historic agreement with Canada’s Apotex
LIFEPharma, a wholly-owned subsidiary of the United Arab Emirates (UAE)-headquartered VPS Healthcare, has announced a historic agreement with Apotex Inc, Canada’s largest producer of generic drugs.
Safety of generics in US questioned
US Food and Drug Administration (FDA) regulations guarantee a safe drug supply. However, author Michael White, from the Health Outcomes, Policy, and Evidence Synthesis Group, University of Connecticut School of Pharmacy, Connecticut, USA, questions the safety of foreign generic drug imports [1].
Generics transition brings economic benefits to Canada
Economic analysis of genericization of cancer medicines in Canada has confirmed their cost-effectiveness. This rare example of an economic evaluation of the benefits of generics was published in Current Oncology [1].
Glenmark and Lupin gain FDA approval for nervous system agents
Indian generics maker Glenmark Pharmaceuticals has been granted tentative US Food and Drug Administration (FDA) approval for its multiple sclerosis (MS) generic, while generics giant Lupin Ltd has also received FDA approval for its Dilantin generic, an anti-seizure medication.
A call for economic reassessment of drug regimens
Canadian researchers have called for the cost-effectiveness of drug products to be routinely reassessed. Their study, published in Current Oncology [1], has shown that cost-effectiveness of products alters significantly after generics are introduced. This has big implications for healthcare budgets and access to medicines, in Canada and worldwide.
Pharmacy chain drives choice among US generics manufacturers
A recent study shows that the dispensing pharmacy chain is a strong driver of generics manufacturer choice in the US, which could have implications for economic models of the generic drugmarket [1].
UK Labour Party proposes state run generics manufacturer
In a speech at the 2019 Labour Party Conference, leader Jeremy Corbyn introduced the ‘Medicines For The Many’ initiative, which aims to put ‘public health before private profit’ and includes plans to establish a state-owned pharmaceutical company to manufacture generic medicines in the UK.
First pregabalin generics approved by FDA
In July 2019, the US Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (pregabalin) for the management of fibromyalgia, postherpetic neuralgia, neuropathic pain associated with diabetic peripheral neuropathy or spinal cord injury, and as adjunct therapy for partial-onset seizures in patients aged 17 years or over.
Ranitidine recalls escalate as FDA declares ‘unacceptable’ levels of NDMA in the drug
On 2 October 2019, the US Food and Drug Administration (FDA) declared that it had found ‘unacceptable’ levels of the probable human carcinogen N-nitrosodimethylamine (NDMA) in the heartburn drug Zantac (ranitidine) and its generic versions.
Strong generics nocebo effect found in US
In the US, generic drug products account for approximately 90% of all prescriptions dispensed [1]. Despite this, there is a continued lack of trust in these drug products. Generics are often perceived as less effective and less safe than their brand-name reference products. Now, researchers at Brigham and Women’s Hospital and Harvard Medical School have confirmed that in the US, generics exhibit a strong nocebo effect. Here, negative bias against generics leads to negative clinical outcomes [2]. The researchers call for more education about generics to increase awareness of their benefits and increase access to these lower-priced medicines.
Alimta and Orfadin generics approved by FDA
The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cancer drug Alimta, and approved Novitium Pharma’s generic equivalent of Swedish Orphan Biovitrum's Orfadin (nitisinone capsules).
New evidence: comparable clinical outcomes for generic and brand medications
New research carried out at Brigham and Women’s Hospital and Harvard Medical School, provides additional evidence that shows generic and brand-name drugs have comparable clinical outcomes [1].
Carcinogen contamination halts distribution of generic Zantac
Heartburn drug Zantac (ranitidine) is being taken off markets worldwide following findings that the medications may be contaminated with cancer-causing agents.
Evaluating success: generics substitution policy in Chile
The effectiveness of Chile’s 2014 generics substitution policy has been assessed by an international team of researchers. In their BMJ Global Health [1] article, the authors reveal that, although there has been a decrease in the uptake of expensive originator drugs, this is not mirrored by an increase in the uptake of less expensive bioequivalent products. This shows that further work is needed to help increase the uptake of generics in Chile.
EMA approves leukaemia and multiple myeloma generics
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 that it had recommended granting marketing authorization for hypertension and leukaemia and multiple myeloma generics.
FDA’s global inspection strategy strengthened
The US Food and Drug Administration (FDA) has implemented a modernized approach to ensure the safety and quality of globally produced innovator and generic medicines. Through its Program Alignment, FDA’s Office of Regulatory Affairs has modernized its workforce and approach to improving public health to keep up with globalization and increasingly complex supply chains. Since FDA implemented Program Alignment in 2017, the regulation of generic medicines has become increasingly strategic, risk-based and efficient.
Generics in Chile: policy success but promotion required
A first-time evaluation [1] of Chile’s generics substitution policy has shown that there has been a decrease in sales of branded originator medicines since policy implementation in 2014. However, this was not mirrored by an increase in sales of the corresponding generic drug products. The BMJ Global Health [1] article authors note that, to improve access to medicines in Chile, more work needs to be done to promote the uptake of generics.
TRIPS flexibilities: current and future use in the SADC region
In response to the HIV/AIDS crisis of the late 1990s, several legal options were introduced to facilitate access to lower-cost treatments. These included flexibilities in the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, known as ‘TRIPS flexibilities’. In a recent review, authors ‘t Hoen, Kujinga and Boulet describe TRIPS flexibilities and discuss their current and future use in the Southern African Development Community (SADC) region [1].
Improving access to medicines: the Doha Declaration on the TRIPS Agreement
In a recent review, authors ‘t Hoen, Kujinga and Boulet describe the role of the Doha Declaration on the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in improving access to essential medicines [1].
China issues list of generics needed in the country
Authorities in China have introduced an initiative which the country hopes will boost the development of generics by encouraging pharmaceutical companies to develop and produce them.
Patent challenges in the SADC region
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
FDA approves Lupin’s generic clobazam and Dr Reddy's launches follow-on sevelamer carbonate
By end of 2018, Lupin Pharmaceuticals Inc received US Food and Drug Administration (FDA) approval for its clobazam oral suspension, 2.5 mg/mL, and Dr Reddy's Laboratories Ltd (Dr Reddy) launched its sevelamer carbonate for oral suspension.
Generics applications under review by EMA – January 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].
Teva receives FDA approval for Sabril and launches Elidel cream
In January 2019, Teva Pharmaceutical Industries (Teva) received US Food and Drug Administration (FDA) approval for its first generic version of Sabril (vigabatrin) and launched a generic version of Elidel (pimecrolimus) cream, 1%, in the US.
Non-profit generics maker expects first generics in 2019
Non-profit generics company, Civica Rx announced on 7 January 2019 that it expects to launch its first generics during 2019 and has added 12 new member groups representing 250 hospitals.
Sun Pharma gets FDA approval for ganirelix acetate and plans to acquire Japan’s Pola Pharma
Sun Pharmaceutical Industries (Sun Pharma), one of India’s largest pharmaceutical company, marks the start of 2019 with two exciting new developments.
Safety of brand-name and generic angiotensin II receptor blockers
Authors of a study carried out in Canada found that there is still uncertainty regarding generics substitution of angiotensin II receptor blockers (ARBs) [1].
Dr Reddy’s launches omeprazole and continues sales of generic Suboxone in the US
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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].
