Generics

Jan Aushadhi and affordability and accessibility of medicines in India

Generics/Research | Posted 05/01/2018

The pharmaceutical industry in India ranks third in the world in terms of volume and 14th in terms of value. According to the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, the total turnover of India’s pharmaceutical industry between 2008 and September 2009 was US$21.04 billion. Hyderabad, Mumbai, Bangalore, Visakhapatnam and Ahmedabad are the major pharmaceutical hubs of India. The domestic market was worth US$13.8 billion in 2013.

Mylan/Aspen launch generic busulfan injection

Generics/News | Posted 08/12/2017

US generics giant Mylan Pharmaceuticals (Mylan) and its partner, generics manufacturer Aspen Pharmacare Holdings (Aspen), announced on 4 December 2017 that it had launched generic Myleran (busulfan) single-dose vial in the US, after receiving final approval from the US Food and Drug Administration (FDA).

Drugmakers waking up to potential value of branded generics

Generics/News | Posted 01/12/2017

Pharma companies are making a move into what may become a lucrative sector – branded generics. The concept is simple – take a generic drug, repackage it and add marketing and hey presto you have a branded generic.

Generic metformin bioequivalent in healthy volunteers in Nigeria

Generics/Research | Posted 01/12/2017

Researchers from Nigeria’s Obafemi Awolowo University have found generic metformin sourced in the country to be ‘not inferior’ to originator metformin [1].

REMS issues come under FDA spotlight

Generics/General | Posted 24/11/2017

US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb has once again chastised brand-name drug companies that deliberately delay federal procedures and use regulations to delay the entry of generics competitors.

Perceptions and attitudes towards generics in South Korea

Generics/Research | Posted 24/11/2017

A survey of the perception and attitude of South Korean physicians towards generics has shown that not much has changed despite the introduction of a new pharmaceutical policy in 2012 [1].

FDA tentatively approves pemetrexed generic

Generics/News | Posted 24/11/2017

Eagle Pharmaceuticals (Eagle) announced on 27 October 2017 that it had been granted tentative approval from the US Food and Drug Administration (FDA) for its generic version of Eli Lilly’s lung cancer blockbuster Alimta (pemetrexed).

Kenya needs to increase use of generics to combat rising costs

Generics/General | Posted 17/11/2017

Kenyan medical insurance management firms are advising that they will only pay for generics and not brand-name prescriptions.

Mergers could be causing price increases for generics

Generics/Research | Posted 10/11/2017

How mergers and acquisitions in the generics sector can be a factor in drug shortages and increasing prices was a question addressed by researchers from Carleton and McGill Universities in Canada [1].

EMA approval for tacrolimus generic

Generics/News | Posted 10/11/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that it had recommended granting marketing authorization for the tacrolimus generic tacforius.

New use for old generic could treat rare cardiovascular condition

Generics/Research | Posted 03/11/2017

Researchers from Canada and the UK may have found a new use for an old generic drug: treatment of the rare cardiovascular condition, pulmonary arterial hypertension (PAH).

Texan judge invalidates Restasis patents

Generics/General | Posted 03/11/2017

On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine ophthalmic emulsion).

Perceptions of generic drugs in Latin America: a Guatemalan case study

Generics/Research | Posted 27/10/2017

A recent assessment of generic drug use in Guatemala [1] revealed a widespread lack of trust in generics, due to a combination of poor quality, powerful advertising campaigns and limited state regulation.

Lupin launches generic pain-relief med in US

Generics/News | Posted 27/10/2017

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 10 October 2017 that it had launched a generic version of Allergan’s Norco (hydrocodone/acetaminophen) pain medication.

FDA trying to reduce hurdles for complex generics

Generics/General | Posted 20/10/2017

Although US Food and Drug Administration (FDA) Commissioner Dr Scott Gottlieb admits that ‘FDA doesn’t control drug pricing’, he points to the fact that FDA ‘policies do affect competition in the market’. With this in mind he announced on 2 October 2017 ‘a major new set of policies’ aimed at making it easier to bring generic competition to complex drugs.

Challenges in the rediscovery of old generics

Generics/Research | Posted 13/10/2017

Finding new treatment options by repurposing generics is a cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics there are multiple obstacles standing in the way [1].

FDA approves lidocaine ointment generic from Vitruvias Therapeutics

Generics/News | Posted 13/10/2017

US-based generics maker Vitruvias Therapeutics (Vitruvias) announced on 29 September 2017 that it had received approval of a new drug application from the US Food and Drug Administration (FDA) for a new drug.

Repurposing thioguanine

Generics/Research | Posted 06/10/2017

Repurposing and re-registering old generics is a cost-effective and time-efficient way of finding new purposes for existing drugs. One such ‘old generic’ that has been repurposed and re-registered is thioguanine [1].

US tribal patent deal could prevent generics

Generics/General | Posted 06/10/2017

A deal made between Allergan and a native American tribe could potentially protect the company from challenges on its dry eye drug Restasis (cyclosporine ophthalmic emulsion) and prevent competition from generics in the US.

Repurposing and re-registering old generics

Generics/Research | Posted 29/09/2017

Finding new indications for existing drugs is better known as drug rediscovery, drug repurposing or drug repositioning. It is cost-effective and time-efficient way of finding a new purpose for old drugs. However, when it comes to the rediscovery of old generics, the lack of a formal regulatory pathway for such drugs and a lack of economic interest by pharmaceutical companies, makes it a challenging pursuit [1].