Generics
Competition does not curb high drug prices
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
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
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
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 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
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
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
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 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
In Australia, the promotion of medicines to healthcare professionals is controlled by self-regulatory schemes operated by the pharmaceutical industry.
