TY - JOUR
T1 - Transitioning Long-Acting Products to a Generic Marketplace
T2 - What’s Missing?
AU - Brown Ripin, David H.
AU - Catlin, Kelly
AU - Lewis, Linda
AU - Resar, Danielle
AU - Amole, Carolyn
AU - Bollinger, Robert C.
AU - Flexner, Charles
N1 - Publisher Copyright:
© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America. All rights reserved.
PY - 2022/12/1
Y1 - 2022/12/1
N2 - Development of and increased access to generic oral medications to treat high-burden diseases including human immunodeficiency virus (HIV), tuberculosis, viral hepatitis, and malaria have had a major impact on reducing global morbidity and mortality. However, access and adherence to these life-saving treatments remains limited for some of the most vulnerable and underserved populations, for whom stigma, control, and discretion are critical to decisions around care. Current efforts to develop long-acting formulations to treat and prevent these conditions could overcome many of these barriers. However, generic manufacturing of these innovative products will be required to ensure affordable access to the communities and patients in greatest need. Strategic investments in new infrastructure will be required even before markets and manufacturing costs are clear, to ensure that access to these new products is not delayed, particularly for patients in low- and middle-income countries. Unlike conventional oral medications, long-acting products require greater investment for formulation, packaging, and delivery. The requirement for long-term bioequivalence studies will introduce additional delays in regulatory approval of generic long-acting products, and expedited approval pathways must be developed. Lessons learned from the development of long-acting hormonal contraceptives and long-acting antiretroviral products may provide a way forward.
AB - Development of and increased access to generic oral medications to treat high-burden diseases including human immunodeficiency virus (HIV), tuberculosis, viral hepatitis, and malaria have had a major impact on reducing global morbidity and mortality. However, access and adherence to these life-saving treatments remains limited for some of the most vulnerable and underserved populations, for whom stigma, control, and discretion are critical to decisions around care. Current efforts to develop long-acting formulations to treat and prevent these conditions could overcome many of these barriers. However, generic manufacturing of these innovative products will be required to ensure affordable access to the communities and patients in greatest need. Strategic investments in new infrastructure will be required even before markets and manufacturing costs are clear, to ensure that access to these new products is not delayed, particularly for patients in low- and middle-income countries. Unlike conventional oral medications, long-acting products require greater investment for formulation, packaging, and delivery. The requirement for long-term bioequivalence studies will introduce additional delays in regulatory approval of generic long-acting products, and expedited approval pathways must be developed. Lessons learned from the development of long-acting hormonal contraceptives and long-acting antiretroviral products may provide a way forward.
KW - HIV prevention
KW - HIV therapy
KW - generic drug manufacturing
KW - long-acting formulations
KW - regulatory approval
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U2 - 10.1093/cid/ciac753
DO - 10.1093/cid/ciac753
M3 - Article
C2 - 36410379
AN - SCOPUS:85142336711
SN - 1058-4838
VL - 75
SP - S557-S561
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - Supplement_4
ER -