The Market for Biosimilars: Evolution and Policy Options

OHE Briefing, No. 45, October 2008

24 Pages Posted: 27 Aug 2015

See all articles by Deven Chauhan

Deven Chauhan

Merck & Co., Inc. - Merck Serono Company

Adrian Towse

Office of Health Economics

Jorge Mestre-Ferrandiz

Office of Health Economics

Date Written: October 1, 2008

Abstract

• Biopharmaceuticals are more complex agents than conventional chemical entities and therefore are more difficult to replicate on patent expiry. Off-patent versions of the originator product cannot rely on a simple demonstration of chemical comparability. They are best described as biosimilar.

• As a consequence biosimilar markets will evolve in a more complex way than traditional small molecule chemical generics markets.

• Regulators will need clinical trial evidence prelaunch of efficacy and safety, and clinicians will require post-launch “patient safety year” (PSY) evidence that biosimilars are in practice equivalent in effect and safety to originators.

• As a consequence generic companies may need commercial partners to enter biosimilar markets successfully and governments and other payers need to behave differently. Post patent expiry price cuts and/or the use of reference pricing will deter biosimilar entry and reduce long term savings.

• Governments and other payers should encourage pharmacovigilance and other outcomes studies that produce PSY data that will encourage interchangeability and greater price competition. Over time these markets can become biogeneric.

• Outcomes data will also help assess the value for money of second generation biopharmaceutical products as compared to the first generation originator and biosimilar products.

Suggested Citation

Chauhan, Deven and Towse, Adrian and Mestre-Ferrandiz, Jorge, The Market for Biosimilars: Evolution and Policy Options (October 1, 2008). OHE Briefing, No. 45, October 2008, Available at SSRN: https://ssrn.com/abstract=2641004

Deven Chauhan

Merck & Co., Inc. - Merck Serono Company ( email )

One Technology Place
Rockland, MA 02370
United States

Adrian Towse (Contact Author)

Office of Health Economics ( email )

12 Whitehall
London, SW1A 2DY
United Kingdom
+44 207 747 1407 (Phone)
+44 207 747 1419 (Fax)

HOME PAGE: http://www.ohe.org

Jorge Mestre-Ferrandiz

Office of Health Economics ( email )

12 Whitehall
London, SW1A 2DY
United Kingdom

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