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A reappraisal of generic bisphosphonates in osteoporosis

A reappraisal of generic bisphosphonates in osteoporosis
A reappraisal of generic bisphosphonates in osteoporosis
The competitive price of generic bisphosphonates has had a marked effect on practice guidelines, but an increasing body of evidence suggests that they have more limited effectiveness than generally assumed.

INTRODUCTION:
The purpose of this study is to review the impact of generic bisphosphonates on effectiveness in the treatment of osteoporosis.

METHODS:
This study is a literature review.

RESULTS:
A substantial body of evidence indicates that many generic formulations of alendronate are more poorly tolerated than the proprietary preparations which results in significantly poorer adherence and thus effectiveness. Poorer effectiveness may result from faster disintegration times of many generics that increase the likelihood of adherence of particulate matter to the oesophageal mucosa. Unfortunately, market authorisation, based on the bioequivalence of generics with a proprietary formulation, does not take into account the potential concerns about safety. The poor adherence of many generic products has implications for guideline development, cost-effectiveness and impact of treatment on the burden of disease.

CONCLUSIONS:
The impact of generic bisphosphonates requires formal testing to re-evaluate their role in the management of osteoporosis.
adherence, cost-effectiveness, effectiveness, gastrointestinal side effects
0937-941X
213-221
Kanis, J.A.
8da04a36-08a7-4310-b4b4-a6d432439587
Reginster, J.Y.
4083b457-5347-4ece-a53e-af19c8868c42
Kaufman, J.M.
b79b47cd-16f0-4619-bf7c-fb77b115d2cd
Ringe, J.D.
28bfb3bb-3ef5-4d52-8f96-1a05ab813fb5
Adachi, J.D.
fad23249-519e-4d11-ac21-f42742cd19fb
Hiligsmann, M.
71dd82d4-b500-45d1-b0d6-3414459cf4c4
Rizzoli, R.
2214fb77-8fb7-4c0b-bfc4-9f8d3cace5d7
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6
Kanis, J.A.
8da04a36-08a7-4310-b4b4-a6d432439587
Reginster, J.Y.
4083b457-5347-4ece-a53e-af19c8868c42
Kaufman, J.M.
b79b47cd-16f0-4619-bf7c-fb77b115d2cd
Ringe, J.D.
28bfb3bb-3ef5-4d52-8f96-1a05ab813fb5
Adachi, J.D.
fad23249-519e-4d11-ac21-f42742cd19fb
Hiligsmann, M.
71dd82d4-b500-45d1-b0d6-3414459cf4c4
Rizzoli, R.
2214fb77-8fb7-4c0b-bfc4-9f8d3cace5d7
Cooper, C.
e05f5612-b493-4273-9b71-9e0ce32bdad6

Kanis, J.A., Reginster, J.Y., Kaufman, J.M., Ringe, J.D., Adachi, J.D., Hiligsmann, M., Rizzoli, R. and Cooper, C. (2012) A reappraisal of generic bisphosphonates in osteoporosis. Osteoporosis International, 23 (1), 213-221. (doi:10.1007/s00198-011-1796-6). (PMID:21953472)

Record type: Article

Abstract

The competitive price of generic bisphosphonates has had a marked effect on practice guidelines, but an increasing body of evidence suggests that they have more limited effectiveness than generally assumed.

INTRODUCTION:
The purpose of this study is to review the impact of generic bisphosphonates on effectiveness in the treatment of osteoporosis.

METHODS:
This study is a literature review.

RESULTS:
A substantial body of evidence indicates that many generic formulations of alendronate are more poorly tolerated than the proprietary preparations which results in significantly poorer adherence and thus effectiveness. Poorer effectiveness may result from faster disintegration times of many generics that increase the likelihood of adherence of particulate matter to the oesophageal mucosa. Unfortunately, market authorisation, based on the bioequivalence of generics with a proprietary formulation, does not take into account the potential concerns about safety. The poor adherence of many generic products has implications for guideline development, cost-effectiveness and impact of treatment on the burden of disease.

CONCLUSIONS:
The impact of generic bisphosphonates requires formal testing to re-evaluate their role in the management of osteoporosis.

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More information

e-pub ahead of print date: 28 September 2011
Published date: January 2012
Keywords: adherence, cost-effectiveness, effectiveness, gastrointestinal side effects
Organisations: Faculty of Health Sciences

Identifiers

Local EPrints ID: 336646
URI: http://eprints.soton.ac.uk/id/eprint/336646
ISSN: 0937-941X
PURE UUID: 8080dc8c-9d48-41d8-983b-3b40a7d9cc6d
ORCID for C. Cooper: ORCID iD orcid.org/0000-0003-3510-0709

Catalogue record

Date deposited: 02 Apr 2012 11:48
Last modified: 18 Mar 2024 02:45

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Contributors

Author: J.A. Kanis
Author: J.Y. Reginster
Author: J.M. Kaufman
Author: J.D. Ringe
Author: J.D. Adachi
Author: M. Hiligsmann
Author: R. Rizzoli
Author: C. Cooper ORCID iD

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