Many generics companies have low-cost structure margins and have produced simple copies of brand-name drugs. A number of them, however, have become involved in innovative R&D to produce new chemical entities and products incorporating novel drug delivery systems. The market for innovative pharmaceuticals continues to grow as new improved therapies become available, thus offering ambitious generics companies an incentive to develop novel products alongside their more traditional ones. The strategies needed to succeed in innovative R&D are very different to that for generic drugs, however, and so far only a few generics companies have succeeded in taking such steps.
JacobzoneS. (2001) ‘Pharmaceutical policies in OECD countries: Reconciling social and industrial goals’, Organisation for Economic Cooperation and Development, DEELSA/ELSA/WD(2000)1, available at http://www.oecd.org/.
2.
KermaniF. (2000) ‘Global Pharmaceutical Pricing: Strategic Issues and Practical Guidelines’, Urch Publishing, available at http://www.urchpublishing.com.
3.
KermaniF.FindlayG. (2000) ‘The Pharmaceutical R&D Compendium’, CMR International, available at http://www.cmr.org/.
4.
Anon (1999) ‘Pharma 2005: An Industrial Revolution in R&D’, PricewaterhouseCoopers.
5.
KermaniF.BonacossaP. (2003) ‘Pharma R&D in Europe and the US: A comparative analysis’, Contract Pharma magazine, September, pp. 58–67.
Anon (2002) ‘Recombinant Capital and Signals’ Stock Report’, May, available at http://www.signalsmag.com/.
8.
HansenN.TunnahP. (2003) ‘The generics challenge: Seeking the elusive profit margin’Journal of Generic MedicinesVol. 1, No. 1, pp. 6–12.
9.
Anon (2003) ‘Total Cost to Develop a New Prescription Drug, Including Cost of Post-Approval Research, is $897 Million’, The Tufts Center for the Study of Drug Development, Press Release, 13th May, available at http://csdd.tufts.edu.
10.
MullinR. (2003) ‘Drug Development Costs About $1.7 Billion’Chemical & Engineering NewsVol. 81, No. 50, p. 8.
11.
AshtonG.KermaniF. (2002) ‘Getting to grips with attrition rates’CMR NewsVol. 20, No. 1, pp. 8–9, available at http://www.cmr.org.
12.
DrewsJ. (1998) ‘Innovation deficit revisited: Reflections on the productivity of pharmaceutical R&D’Drug Discovery TodayVol. 3, No. 11, pp. 491–494.
13.
SculthorpeP.LowmanD. (2003) ‘New Medicine Launches 2002’, CMR International, available at http://www.cmr.org.
14.
KermaniF.Van den HaakM. (2002) ‘Drug development 2001’, CMR International, available at http://www.cmr.org.
15.
LongJ. (2001) ‘Quantifying chemical R&D’Chemical & Engineering NewsVol. 79, No. 24, p. 5.
16.
Anon (2002) ‘Industry Profile 2002’, The Pharmaceutical Research and Manufacturers of America (PhRMA), available at http://www.phrma.org/.
EGA (2002) ‘Bio-pharmaceuticals — Affordability and Access Hindered’, European Generic medicines Association, available at http://www.egagenerics.com/.
20.
Anon (2003) ‘BIO Citizen Petition’ (21 CFR §10.30), 23rd April, Biotechnology Industry Organization Regulatory Policies, available at http://www.bio.org/reg/.
21.
Pliva Corporate Communications Department (2003) ‘Pliva's Fourth R&D Day in London’, 25th November, Pliva, Zagreb, Croatia.
Author's personal communication with WeidenauerUweDr, HEXAL Pharmaforschung GmbH, 83607 Holzkirchen, Germany.
28.
Organisation of Pharmaceutical Producers of India (2003) ‘R&D expenditure of the Indian pharmaceutical industry 1999–2003’, Mumbai, India, available at http://www.indiaoppi.com.
29.
Author's personal communication with AhujaSeema, Senior Manager, Corporate Communications Department, Ranbaxy Laboratories Limited, January 2004.
30.
Anon (2001) ‘Marketing ciprofloxacin — Glaxo ties up with Ranbaxy, Cipla’, The Hindu Business Line, International Edition, Wednesday, 17th October, available at http://www.blonnet.com/businessline/2001/10/17/.
31.
Anon (2001) ‘Dr. Reddy's Laboratories launches fluoxetine in the US generics market’, Biospace News, 3rd August, available at http://www.biospace.com.
