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News

AB004665 Alimta and Orfadin generics approved by FDA posted 15/10/2019

The US Food and Drug Administration (FDA) has tentatively approved Mylan’s pemetrexed, a generic version of Eli Lilly’s cance...

AB004665 EMA approves leukaemia and multiple myeloma generics posted 05/10/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 th...

FDA approves Farxiga generic posted 26/08/2019

The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s...

Certara technology achieves first FDA virtual bioequivalence approval for a complex generic drug posted 09/08/2019

On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation tech...

FDA approves rituximab biosimilar Ruxience posted 09/08/2019

US-based pharma giant Pfizer announced on 23 July 2019 that it had received approval from the US Food and Drug Administration...

 

Research

First pregabalin generics approved by FDA posted 18/10/2019

In July 2019, the US Food and Drug Administration (FDA) approved multiple applications for the first generics of Lyrica (preg...

Strong generics nocebo effect found in US posted 15/10/2019

In the US, generic drug products account for approximately 90% of all prescriptions dispensed [1]. Despite this, there is a c...

New evidence: comparable clinical outcomes for generic and brand medications posted 15/10/2019

New research carried out at Brigham and Women’s Hospital and Harvard Medical School, provides additional evidence that shows...

Evaluating success: generics substitution policy in Chile posted 05/10/2019

The effectiveness of Chile’s 2014 generics substitution policy has been assessed by an international team of researchers. In...

Generics in Chile: policy success but promotion required posted 05/10/2019

A first-time evaluation [1] of Chile’s generics substitution policy has shown that there has been a decrease in sales of bran...

 

General

Ranitidine recalls escalate as FDA declares ‘unacceptable’ levels of NDMA in the drug posted 18/10/2019

On 2 October 2019, the US Food and Drug Administration (FDA) declared that it had found ‘unacceptable’ levels of the probable...

Carcinogen contamination halts distribution of generic Zantac posted 07/10/2019

Heartburn drug Zantac (ranitidine) is being taken off markets worldwide following findings that the medications may be contam...

FDA’s global inspection strategy strengthened posted 27/09/2019

The US Food and Drug Administration (FDA) has implemented a modernized approach to ensure the safety and quality of globally...

China issues list of generics needed in the country posted 30/08/2019

Authorities in China have introduced an initiative which the country hopes will boost the development of generics by encourag...

Generics applications under review by EMA – July 2019 posted 02/08/2019

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the lo...