Delhi Summit Oct. 12th 2007
INTERNATIONAL SUMMIT ON GENERIC ANTITHROMBOTIC DRUGS
A FOCUS ON LOW MOLECULAR WEIGHT HEPARINS AND RELATED DRUGS.
A TIMELY NEED TO DEVELOP OBJECTIVE GUIDELINES.
October 12, 2007
Taj Mahal Hotel, Mansingh Road, New Delhi, India
Report on the INTERNATIONAL SUMMIT ON GENERIC ANTITHROMBOTIC DRUGS
By Dr E. Kalodiki MD BA DIC PhD.
This international summit took place on Friday October the 12th 2007, at New
Delhi, Under the Auspices of the:
International Union of Angiology (IUA),
International Academy of Clinical and Applied Thrombosis (ICATH)
North American Thrombosis Forum (NATF) and
South Asian Society of Atherosclerosis and Thrombosis (SASAT)
The program directors were: Dr. Jawed Fareed, Ph.D. Loyola University Medical
Center Maywood Illinois, USA and Dr. Gundu Rao, Ph.D. University of Minneapolis,
Minnesota USA. The local organizer was Dr. Renu Saxena, Professor, All India
Institute of Medical Sciences, New Delhi.
The scope of the conference was to recognize the timely issues related to the
evolution of guidelines for the objective and ethical development of generic
antithrombotic drugs with particular reference to Low Molecular Weight Heparins
(LMWHs). Current guidelines for the generic conversion of branded antithrombotic
drugs, in particular heparins, are inadequate at this time. Moreover, in the
case of LMWHs these guidelines are invalid. Very little has been done by various
organizations to address these issues. This has led to the development and
introduction of several generic antithrombotic drugs globally, some of which
were withdrawn after the initial approval, to avoid patient care adverse-related
issues. The IUA, SASAT and ICATH have addressed these issues periodically. More
recently, the EMEA and other peer groups have also addressed concerns related to
the current status of this problem. This summit was organized to brief the
distinguished panel on the problems and issues and generate scientific input for
objective guidelines for the development of antithrombotic drugs, in particular
the LMWHs. The Summit resulted in the following recommendations, which will be
formalized in conjunction with the different sponsoring organizations and
further discussions with other groups such as the ad hoc group on heparin
chaired by Dr. Harenberg on behalf of the subcommittee on the control of
anticoagulation of the ISTH. The recommendations are briefly outlined below:
- Despite several initiatives at regional and international levels, there are
no clear guidelines for the approval of the generic versions of low molecular
weight heparins at this time. Therefore, there is a need to formalize group
consensus and recommendations for the development and approval process.
- The current guidelines for the acceptance of generic drugs are not valid for
the complex drugs such as the low molecular weight heparins and other biosimilars. Moreover, a clear distinction between the biosimilars in terms of
their origin and chemical nature must be made (eg: proteins, carbohydrates,
lipids and nucleic acid). A blanket recommendation for all may not be
applicable.
- There is a need for the pharmacopial monographs for each of the individual
low molecular weight heparins and related drugs such as the pentasaccharide.
This monograph should be agreed upon at a global level and
adhered to for the development of generic products.
- Because of the complex nature of low molecular weight heparins, specific
bioassays for the biological activities including both the anticoagulant and
non-anticoagulant effects should be considered. Moreover, in vivo pharmacodynamic effects should be validated.
- Microchemical structures including specific molecular characteristics,
physicochemical characteristics and other product attributes as specified by the
innovator and scientific community should be considered and the generic product
should be comparable.
- Because of the clinical spectrum and approval for different indications for
different products. It may be necessary to validate the safety and efficacy of
the generic versions of branded products in clinical settings.
- The discussions on guideline development should be extended at regulatory
levels and such organizations as US FDA, EMEA, WHO and other regulatory
organizations should be invited to participate in open discussions with
scientific groups. Follow up meetings should be held in conjunction with
scientific organizations such as the IUA, SASAT, ICATH, ISTH and NATF to discuss
relevant issues.
The deliberations of the meeting will be published as a white paper in
International Angiology and JCATH. Apart from the participants the international
experts listed in this section will provide their input via e-mail or phone
conferences, which will be incorporated in the final document.
Introduction -
Scientific Program -
Topics & Contributors -
Acknowledgments
Documents (Registration, Reimbursed Expenses, Reference Materials)
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