Monday, 3 March 2014

Oncology 'win' for Mildura: Appointment of Dr Divy will mean treatment closer to home

IN a first for Sunraysia, Mildura Base Hospital has secured the services of a resident oncologist.
Dr Divyanshu Dua started in the role last Monday, after an extensive recruitment process to bring him to the region.
Dr Dua has relocated with his young family to Mildura after working in London.
Before his arrival in Mildura, he trained in Adelaide and worked with major tertiary teaching hospitals including Royal Adelaide Hospital, Flinders Medical centre and Lyell McEwin Hospital.
Dr Dua is a Fellow of Royal Australasian College of Physicians with speciality training in medical oncology and general medicine experience in India and the UK. 
He intends to pursue research in medical oncology with special interests in lung, genitourinary and melanoma drug development.
MBH director of medical services Alison Walker said Dr Dua’s appointment was a win for Sunraysia.
“In the past we’ve had physician Terry Cook and visiting oncologists from Bendigo and Melbourne,” she said.
“That arrangement has worked well, but the addition of Divy will allow more oncology and general physician services to be provided here.”
Dr Walker said Dr Dua was attracted to the region because of its excellent sporting facilities, the great weather and family-friendly lifestyle.
“We advertised and had two or three people interested, but Divy was the ideal candidate,” she said.
“He knows he is here to build on our service.”

Sunday, 2 March 2014

New Zealand guidelines for biosimilars

The regulatory body for approval of medicines in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The agency is responsible for the regulation of medicines and medical devices in New Zealand, ensuring that medicines and medical devices are acceptably safe.
Medsafe defines a biosimilar as a new biological product that is similar to another biological medicine that has been granted consent to be marketed in New Zealand (the biological reference).
Medsafe has stated that approval of a biosimilar medicine is based on non-clinical studies (pharmacokinetic and pharmacodynamic studies) as well as comparative human clinical studies. Data provided to support the application should show no important difference between the biosimilar and the reference product in terms of efficacy and safety.
However, consensus regarding the interchangeability of a biosimilar medicine and its reference product has yet to be reached. The prescribing physician should therefore take this into account when considering interchanging the medicines.
Medsafe does not cite any specific New Zealand guidelines for biosimilars, but refers biosimilars manufacturers to both the US Food and Drug Administration draft guidelines and the European Medicines Agency guidelines for more information.
Source: http://www.gabionline.net/Guidelines/New-Zealand-guidelines-for-biosimilars?utm_source=GONL3&utm_campaign=6826138f58-GONL+V14B28-3&utm_medium=email&utm_term=0_735577ae74-6826138f58-72205817

FDA and Health Canada streamline drug submissions

The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug authorization data online using a special dedicated channel of FDA’s existing system.
The system uses secure Internet connections to receive electronic versions of medical product applications and related documents from industry sponsors seeking regulatory approval. FDA’s Electronic Submissions Gateway has been running since 2006 and this latest modification allows it to receive submissions from Canada as well as the US, using the same interface and technology. Submissions can then be transmitted to one or both regulatory authorities.
The gateway is an outcome of the US–Canada Regulatory Cooperation Council, which was first announced by US President Barack Obama in February 2011. Thus, it has progressed from concept to delivery in only 26 months.
‘By streamlining the process to allow industry to submit information in an easy and secure manner, Canadians will benefit from faster access to safe and effective medications. This will encourage more companies to bring their products to Canada,’ said Canada’s Minister of Health, Rona Ambrose.
The collaboration should yield long-term positive outcomes for both FDA and Health Canada, streamlining both agencies’ submission requirements while maintaining consistency in regulatory requirements. There could also be cost savings for regulated industry, which would not have to follow separate technical requirements for submission to the two countries.
This is not the first collaboration FDA is carrying out with other regulatory agencies. This announcement follows a previous initiative announced by FDA to collaborate with the European Medicines Agency, which provides a mechanism to conduct joint facility inspections for generics applications submitted to both agencies [1].
‘This is yet another example of the steps FDA is taking as part of our Global Initiative, which envisions enhanced collaboration with our regulatory partners,’ said Dr Robert Yetter, Associate Directory for Review Management in FDA’s Center for Biologics Evaluation and Research.

Source: http://www.gabionline.net/Policies-Legislation/FDA-and-Health-Canada-streamline-drug-submissions?utm_source=GONL3&utm_campaign=6826138f58-GONL+V14B28-3&utm_medium=email&utm_term=0_735577ae74-6826138f58-72205817

Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’

India-based biologicals specialist Biocon and US generics maker Mylan have challenged the Delhi High Court’s interim order that barred them from using Switzerland-based drug giant Roche’s data to sell their ‘similar biologic’ versions of Roche’s breast cancer blockbuster Herceptin (trastuzumab).
The Delhi High Court had restrained Biocon and Mylan from claiming that their versions of the breast cancer drug are ‘biosimilars’ of Roche’s originator product [1]. The court stated that the companies should refrain from ‘relying upon’ or ‘referring to Herceptin’ or any data related to it for selling or promoting their brands Canmab (Biocon) and Hertaz (Mylan)
Roche has told the court that Biocon and Mylan’s drugs are being misrepresented as ‘biosimilar trastuzumab’ and ‘biosimilar version of Herceptin’ without following the due process in accordance with the guidelines on ‘similar biologics’ for gaining approval in India. Roche also claims that there is no public record, in India or elsewhere, to show that the two companies actually carried out phase I and phase II trials on their trastuzumab versions. Finally, Roche claims that Biocon and Mylan’s package inserts are a ‘slavish copy’ of the originator’s version. Roche also says that the claims made by Biocon and Mylan in the package insert go beyond, and are even contrary to, what the drug regulator had originally approved.
The Delhi High Court has said that it is not taking an immediate position on whether the two firms had the drug regulator’s approval for the package insert they were using to sell their ‘similar biologic’ version of trastuzumab. However, Biocon and Mylan are insisting that the package insert was duly approved by the Indian drug regulatory agency the Drug Controller General of India (DCGI).
Biocon and Mylan also state that ‘unless the main approval or the approval for package insert is revoked or cancelled, we are entitled to use the same in their packaging while marketing the drug.’
Roche is also suing the DCGI for giving permission for the launch of the trastuzumab ‘similar biologics’, alleging that the regulator failed to follow due diligence and may have used Roche data when considering the applications. The case is due in court on 28 February 2014 [1].
Source: http://www.gabionline.net/Biosimilars/News/Biocon-and-Mylan-challenge-Indian-ban-on-trastuzumab-similar-biologics?utm_source=GONL3&utm_campaign=6826138f58-GONL+V14B28-3&utm_medium=email&utm_term=0_735577ae74-6826138f58-72205817

FDA starts widespread testing of generics

The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made.
The new initiative involves at least a dozen academic centres, in a testing programme that will run through 2017. Research for 2014 will focus on heart drugs, attention deficit hyperactivity disorder (ADHD) treatments, immunosuppressants, anti-seizure medicines and antidepressants.
In the past, testing of generics was done only occasionally in the US, due mainly to a very small budget – US$2 or US$3 million each year – being allocated for such research, according to Ms Kathleen Uhl, Acting Director of the FDA’s Office of Generic Drugs. The collection of generic user fees from industry has ‘enabled the agency to put more broad-based testing into action,’ Ms Uhl toldBloomberg.
Among the academic centres to receive grants are Duke University, Johns Hopkins University, Brigham and Women’s Hospital in Boston and the universities of Florida, Michigan and Maryland. Researchers are studying how absorption, inactive ingredients and packaging affect generic drug efficacy.
The agency is also reviewing a 2013 study by a Boston-based researcher that found widespread impurities in generics of Pfizer’s blockbuster high cholesterol treatment Lipitor (atorvastatin) made outside of the US.

Source: http://www.gabionline.net/Generics/General/FDA-starts-widespread-testing-of-generics?utm_source=GONL3&utm_campaign=6826138f58-GONL+V14B28-3&utm_medium=email&utm_term=0_735577ae74-6826138f58-72205817

Compliance and persistence same for generic and brand-name alendronate

A retrospective analysis of data in Italy has shown that patients taking generic and brand-name alendronate showed the same rates of persistence and compliance [1].
Alendronate is used to treat osteoporosis (a condition in which the bones become thin, weak and break easily) and to prevent osteoporosis in postmenopausal women.
A retrospective analysis was carried out using data collected from the administrative databases of five Local Healthcare Units (Aziende Sanitarie Locali) from the Lombardy region in Italy. The analysis compared differences in persistence and compliance between generic alendronate (ATC - M05BA04) and brand-name alendronate (Fosamax) in clinical practice.
The sample included 20,711 patients from the provinces of Bergamo, Lecco, Milan and Pavia. Patients were included if they had received at least one prescription of alendronate (generic or brand-name) between January 2008 and December 2008. Patients were observed for a period of 34 months starting from the date of the first drug prescription (index date).
Patients were excluded if they had received systemic corticosteroid in the two months prior to the index date (in order to exclude patients with corticosteroid induced osteoporosis), sporadic patients (patients that had only one prescription for alendronate) and patients who had received both generic and brand-name alendronate during the study period.
Persistence was calculated as a continuous variable, in terms of the number of therapy days for which the therapy was available, without interruption. The total number of therapy days was analysed by means of the Defined Daily Dose (DDD). Compliance to therapy was calculated by means of the Medical Possession Ratio (MPR). The MPR was defined as the ratio between the number of packs in the period of persistence multiplied by the number of DDDs per pack, divided by the total days until change of therapy (i.e. persistence).
The number of days that patients were persistent was on average 316 days for the brand-name group compared to 362 days for the generics group. Interestingly, patients had a better persistence (not statistically significant) when using generic alendronate (about 46 days). Patients’ compliance was on average 0.70 for the brand-name group compared to 0.72 for the generics group (not statistically significant). Overall, the results showed that 70% of patients were adherent to therapy with alendronate, whether it be a generic or brand-name drug, during the persistence period.
The price difference between off-patent brand-name drugs and generics in Italy is paid by patients, which can often reduce adherence to therapy. The authors therefore concluded that generics ‘can bring about an increased efficiency in health systems and increase the percentage of population benefitting from a medical care plan’.
Conflict of interest
The authors of the research paper [1]reported no conflicts of interest that were directly relevant to the content of this study.

Source: http://www.gabionline.net/Generics/Research/Compliance-and-persistence-same-for-generic-and-brand-name-alendronate?utm_source=GONL3&utm_campaign=6826138f58-GONL+V14B28-3&utm_medium=email&utm_term=0_735577ae74-6826138f58-72205817

EU majority says same INNs for biosimilars

According to recently published summary minutes from an October 2013 meeting of the European Commission’s Pharmaceutical Committee, the majority of EU Member States agree that biosimilars should have the same international non-proprietary name (INN) as their reference biological.
The agenda point was discussed, during the 71st Pharmaceutical Committee meeting held on 23 October 2013 in Brussels, Belgium, as a result of industry stakeholders seeking support for the ongoing discussions over the use of an INN qualifier for biosimilars in the World Health Organization (WHO) INN Programme.
It has been proposed at WHO meetings that biosimilars be given unique names, by the use of a three-letter code (or fantasy suffix) [1].
The majority of EU Member States, however, ‘strongly supported’ the current EU thinking that biosimilars ‘should be closely aligned’ with their reference biological and that an INN qualifier for biosimilars ‘would be contrary to such alignment’.
Several Member States also voiced concern that a distinct INN for biosimilars ‘could undermine the trust of healthcare professionals and the public’ in biosimilars. The Member States reiterated that ‘the same INN should be used for both the reference medicinal products and the biosimilar medicinal products’.
Traceability and attribution of adverse reactions has often been stated as a reason for biosimilars and originator biologicals to have unique names. This was not seen as a problem by the EU Member States. On this subject, Member States, in general, answered that both the brand-name and INN are reported, that batch number is often reported (frequency seems to vary between Member States) and that it is not problematic to identify the biological medicinal products which are the subject of adverse reaction reports.
The Commission Representative committed to report the outcome of the discussion in the WHO INN Programme to the European Commission’s Pharmaceutical Committee.
Source: http://www.gabionline.net/Biosimilars/General/EU-majority-says-same-INNs-for-biosimilars?utm_source=GONL3&utm_campaign=6826138f58-GONL+V14B28-3&utm_medium=email&utm_term=0_735577ae74-6826138f58-72205817