Contributions
Abstract: 242
Type: Hot Topic
Abstract Category: N/A
Although MS prevalence in LATAM is low, the economic impact of the disease is significant. Limited access to FDA- or EMA-approved disease modifying therapies in most countries in the region has meant that few patients can access modern therapeutic protocols.
To reduce costs and increase access to health care, nearly every country has adopted laws, policies and/or regulations encouraging substitution of original drug formulations with copies. However, lack of enforcement of regulatory requirements governing the quality of copies in different markets is prevalent. In many LATAM countries, as well as in other developing regions around the world, standards are less stringent than those enforced by the FDA, EMA or WHO. Pharmacovigilance programs for copies are not enforced in most of the region. When adverse events and toxicity emerge, it is vital they be reported, analyzed and communicated effectively to relevant stakeholders; otherwise, patients living in countries with lax control systems, or those importing substandard copies may be at risk.
There can be serious consequences to use of inadequately tested, substandard copies, particularly in patients who require well-controlled treatment. Review of the literature on follow-on products that are not adequately tested clearly illustrates toxicity risks as well as lack of efficacy exists. The latter is particularly important in a disease like MS, in which lower or absent efficacy are only evidenced months or years later in many cases, once the disease has become irreversible.
This update do not intend to generate a controversy between original vs. follow-on compounds, but to recognize that the real controversy lies between marketing copies adequately meeting regulatory requirements vs. those evaluated without any degree of scientific rigor (or are not evaluated at all), or not subject to pharmacovigilance control, ultimately jeopardizing patient healthcare.
Disclosure: JC is a board member of Merck-Serono Argentina, Novartis Argentina, Genzyme LATAM, Genzyme global, Biogen-Idec LATAM, and Merck-Serono LATAM. He is part of the Steering Committee for the clinical trials of Ofatumumab (Novartis Global). Dr. Correale has received reimbursement for developing educational presentations for Merck-Serono Argentina, Merck-Serono LATAM, Biogen-Idec Argentina, Genzyme Argentina, Novartis Argentina, Novartis LATAM, Novartis Global, and TEVA Argentina as well as professional travel/accommodations stipends.
Abstract: 242
Type: Hot Topic
Abstract Category: N/A
Although MS prevalence in LATAM is low, the economic impact of the disease is significant. Limited access to FDA- or EMA-approved disease modifying therapies in most countries in the region has meant that few patients can access modern therapeutic protocols.
To reduce costs and increase access to health care, nearly every country has adopted laws, policies and/or regulations encouraging substitution of original drug formulations with copies. However, lack of enforcement of regulatory requirements governing the quality of copies in different markets is prevalent. In many LATAM countries, as well as in other developing regions around the world, standards are less stringent than those enforced by the FDA, EMA or WHO. Pharmacovigilance programs for copies are not enforced in most of the region. When adverse events and toxicity emerge, it is vital they be reported, analyzed and communicated effectively to relevant stakeholders; otherwise, patients living in countries with lax control systems, or those importing substandard copies may be at risk.
There can be serious consequences to use of inadequately tested, substandard copies, particularly in patients who require well-controlled treatment. Review of the literature on follow-on products that are not adequately tested clearly illustrates toxicity risks as well as lack of efficacy exists. The latter is particularly important in a disease like MS, in which lower or absent efficacy are only evidenced months or years later in many cases, once the disease has become irreversible.
This update do not intend to generate a controversy between original vs. follow-on compounds, but to recognize that the real controversy lies between marketing copies adequately meeting regulatory requirements vs. those evaluated without any degree of scientific rigor (or are not evaluated at all), or not subject to pharmacovigilance control, ultimately jeopardizing patient healthcare.
Disclosure: JC is a board member of Merck-Serono Argentina, Novartis Argentina, Genzyme LATAM, Genzyme global, Biogen-Idec LATAM, and Merck-Serono LATAM. He is part of the Steering Committee for the clinical trials of Ofatumumab (Novartis Global). Dr. Correale has received reimbursement for developing educational presentations for Merck-Serono Argentina, Merck-Serono LATAM, Biogen-Idec Argentina, Genzyme Argentina, Novartis Argentina, Novartis LATAM, Novartis Global, and TEVA Argentina as well as professional travel/accommodations stipends.