Generics

Natco Pharma and Alvogen launch first US Tamiflu generic

Generics/News | Posted 20/01/2017

Natco Pharma (Natco) and their marketing partner Alvogen have launched the first generic equivalent of Roche’s flu treatment Tamiflu (oseltamivir phosphate) in the US.

UK competition authority accuses Actavis of overcharging NHS

Generics/General | Posted 13/01/2017

The UK’s Competition and Markets Authority (CMA) has accused Actavis of breaching competition law by increasing the price of generic hydrocortisone tablets by more than 9,500−12,000% compared to the brand-name product, which was sold by a different company prior to April 2008.

Mylan launches generic EpiPen

Generics/News | Posted 13/01/2017

US-based drugmaker Mylan announced on 16 December 2016 that it had launched the authorized generic version of its EpiPen (epinephrine) injectors at a wholesale price of US$300 per two-pack. This price, the company says, ‘is more than 50% lower’ than the brand-name price.

Competition does not curb high drug prices

Generics/General | Posted 06/01/2017

With increasing concern over price increases for medicines a new concern being raised is that increased competition in the pharma industry does not always lead to lower prices.

Lupin and Natco’s Armodafinil generic approved to treat sleep disorders by FDA

Generics/News | Posted 06/01/2017

The US subsidiary of Indian drug manufacturer, Lupin Pharmaceuticals, announced on 29 November 2016 that its Armodafinil tablets had received approval from the US Food and Drug Administration (FDA). Marketing and promotion of the product in the US will begin shortly.

Addressing patient misconceptions about generics

Generics/Research | Posted 02/12/2016

In the face of increasing drug costs, substitution by generics is often used as a strategy by healthcare systems to rein in expenditure. However, patient misconceptions about generics can hinder such substitutions. Researchers Sanchez and Zurek discuss how pharmacists can improve this situation by educating patients on the use and safety of generics [1].

FDA reports record number of generics approvals

Generics/General | Posted 02/12/2016

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) latest activity report shows an increase in approvals for generics, including 835 tentative or full approvals issued for the fiscal year (FY) 2016.

Mylan to make generic hepatitis drug under MPP sublicence

Generics/News | Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) announced on 28 November 2016 that the company had signed a sublicence with the Medicines Patent Pool (MPP) to make a generic of Bristol-Myers Squibb’s hepatitis C medicine Daklinza (daclatasvir).

Policies to address price rises in old generics

Generics/Research | Posted 25/11/2016

Old, off-patent drugs are becoming increasingly expensive. But how can policymakers address the problem? Naren P Tallapragada from the Harvard Medical School discusses the underlying causes of the high-cost off-patent drug problem and proposes some policy solutions that could address the problem [1].

First prequalification submissions for generic dolutegravir

Generics/General | Posted 25/11/2016

The Medicines Patent Pool (MPP) announced on 10 November 2016 that two of its generics manufacturing partners are the first companies to apply for prequalification of generic dolutegravir, a new antiretroviral that the MPP licensed from ViiV Healthcare in 2014.

Therapeutic substitution could save Americans US$73 billion

Generics/Research | Posted 18/11/2016

Therapeutic substitution could save the America healthcare system US$73 billion and patients US$24.6 billion in out-of-pocket expenses, according to US researchers [1].

Dr Reddy’s makes deal with Gland Pharma for US injectables

Generics/News | Posted 18/11/2016

Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 October 2016 that it had entered into a ‘strategic collaboration’ with India-based sterile dosage form maker Gland Pharma.

Transparency in the Australian pharmaceutical industry

Generics/Research | Posted 11/11/2016

In Australia, the promotion of medicines to healthcare professionals is controlled by self-regulatory schemes operated by the pharmaceutical industry.

Factors affecting generics entry

Generics/Research | Posted 04/11/2016

Edward Kong, Research Assistant at the Yale University, Department of Economics, carried out a study into the factors that influence a generics maker’s decision to enter a specific market [1].

Sandoz petitions FDA over requirements for generics of Advair Diskus

Generics/General | Posted 04/11/2016

Sandoz has asked the US Food and Drug Administration (FDA) not to approve generics of GlaxoSmithKline’s (GSK) chronic obstructive pulmonary disorder (COPD) treatment Advair Diskus (fluticasone/salmeterol), unless the generics applications contain the results of pharmacokinetic (PK) bioequivalence studies that ‘ensure the safety and efficacy’ of the products.

Teva sells Actavis’ UK and Ireland generics business to Intas

Generics/News | Posted 28/10/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 5 October 2016 that it had agreed to sell the UK and Ireland generics business of Actavis to Accord Healthcare (a subsidiary of Intas Pharmaceuticals) for GBP 603 million, subject to final approval from the European Commission (EC).

Competition in the generics industry

Generics/Research | Posted 21/10/2016

In theory, an increase in the use of generics should help to reduce overall drug expenditures. However, growth in spending on medicines in the US increased by US$46.2 billion, or 12.2%, over 2014 levels, reaching US$425 billion in 2015 [1]. This increase comes despite a simultaneous growth in spending on generics, which increased by US$7.9 billion (7.4%) to US$114.1 billion in 2015.

Mylan agrees to pay fine over EpiPen rebates

Generics/News | Posted 21/10/2016

US-based drugmaker Mylan announced on 7 October 2016 that it had agreed to pay US$465 million to the US Department of Justice (DOJ) and other government agencies. The agreement, the company says, will resolve questions that have been raised about the classification of its EpiPen injectors for the Medicaid Drug Rebate Program. The deal has also been made without the company having to admit any wrongdoing.