EuroMeeting Globalisation Track: International collaboration in the review of Generic Drugs

Chair(s):Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Description:
With the globalisation trend, an increasing number of generic medicines manufacturers are keen to introduce their products at global scale. For health authorities, a need for fast supply of medicinal products from other markets may occur in case of unexpected shortages in their region. Single development program and more harmonised assessments of generic medicinal products between various markets in order to avoid unnecessary duplications of effort shall be discussed among the authorities and industry.

Presentation(s) & Speaker(s):
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- EGA proposal
Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- View of the CMDh
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
Federal Institute for Drugs and Medical Devices, Germany

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- Health Canada perspective
Mike D. Ward
Manager, International Programs Division
Health Canada, Canada

for more Globalisation track sessions see Theme 13...

J&J Permits Generic Production Of Patented HIV Drug to benefit sub-saharan Africa and poor countries

J&J Permits Generic Production Of Patented HIV Drug.

Bloomberg News (11/30, Armstrong) reports Johnson & Johnson announced it would allow generic-drug manufacturers to "make and distribute copies of its HIV medicine Prezista [darunavir] in sub-Saharan Africa and poor countries." The New Brunswick, New Jersey, pharmaceutical company said it "won't enforce patent claims" against drugmakers that produce generic copies of its antiretroviral drug. However, the J&J agreement "says that generics manufacturers can only distribute the medicine for patients living in the African and least-developed countries." According to the WHO, about "34.2 million people worldwide are infected with HIV, including 22.9 million in Africa."

        Reuters (11/30, Hirschler) notes that J&J already has one such agreement under which Durban, South Africa-based Aspen Pharmacare produces darunavir at a $2.22 daily price. AFP (11/30) also covers the J&J announcement.

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India Pushes To End Sale Of Branded Drugs, by Ed Silverman

The drug controller of India wants to prohibit medicines from being sold under brand names in a bid to accelerate the sale of lower-cost generics. In fact, states have been ordered to stop issuing licenses for the manufacture or sale of drugs under brand names, The Economic Times reports.

Under the plan, all drugmakers applying for a license to market or manufacture fixed dose combination drugs will have to submit the generic name and not the brand names. The move comes shortly after a parliamentary committee issued a report that also strongly opposed issuing licenses that use brand names, the paper writes.

“We want to gradually move towards a future where we will not issue any brand or trade names. We are going all out to push generic drugs solely for the benefit of the public,” Drugs Controller GN Singh tells the paper.

for complete article:  India Pushes To End Sale Of Branded Drugs

Samsung to launch biosimilars by 2015 at half the current prices - from Generics and Biosimilars Online

South Korean electronics giant Samsung told the Financial Times that it plans to launch biosimilars by 2015 at half the prices that patients in Europe and the US currently pay.

The biotechnology arm of Samsung, Samsung BioLogics, has aims to complete a manufacturing plant outside Seoul, South Korea, by June 2012 and has committed more than US$2 billion in investments in its new plant up to 2020.

Mr Tae-Han Kim, President of Samsung BioLogics, told the Financial Times that ‘biopharmaceutical companies are good for sales, and biotech companies for innovation, but neither is good for manufacturing. It is in Samsung’s DNA to produce products at low prices while meeting legal and industry requirements. The price of monoclonal antibodies is very expensive and not affordable to all patients. That is a heavy burden on governments and [healthcare] payers.’

Samsung BioLogics ‘aims to be a world leader in biologicals development and manufacturing and to dedicate itself to improving global healthcare’ and it is doing this by creating partnerships.
In December 2011, the company entered into a biosimilars joint venture with US biotechnology company Biogen Idec and back in February 2011 Samsung made a deal with contract research organisation Quintiles to provide biologicals manufacturing and biosimilars development [1]. However, Samsung is not stopping there and Mr Kim added that ‘the company was also seeking other partnerships, and planned to start developing its own innovative medicines in the coming years.’

Samsung has been pursuing biosimilars since 2009, describing it as a business in which it aimed to grow strategically and would participate in ‘aggressively’.

South Korea is expected to become a major player in the global biosimilars market. Its long history in manufacturing biologicals, advanced R & D capability and the lack of patent issues, coupled with the government’s support for biosimilar development make South Korea an ideal place to develop biosimilars [2].

Related article
Samsung to enter biosimilars market

References
1. GaBI Online - Generics and Biosimilars Initiative. Samsung makes biosimilars deal with Biogen Idec [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 23]. Available from: www.gabionline.net/Biosimilars/News/Samsung-makes-biosimilars-deal-with-Biogen-Idec

2. GaBI Online - Generics and Biosimilars Initiative. South Korea to emerge as global leader in biosimilar R & D [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Apr 23]. Available from: www.gabionline.net/Biosimilars/News/South-Korea-to-emerge-as-global-leader-in-biosimilar-R-D

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Generics and Biosimilars Initiative (GaBI)
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