Mexico: Generics and Biosimilars Overview

Introduction

Interchangeable generics (GIs; genéricos intercambiables) have traditionally held a small share of the Mexican market; however, are anticipated to experience significant growth following the removal of similares in February 2010. In addition, consumer preference for low-cost pharmaceuticals and the growth of health insurance is set to drive the uptake of GIs.

Features and benefits

• Compares the Mexican generics market in value and volume terms to other leading developed and emerging markets.
• Insight into the key drivers and resistors to generics uptake in Mexico.
• Assesses strategies employed by the leading generics companies operating in Mexico.
• Analyses biosimilar uptake in Mexico and provides insight into the future opportunities for biosimilar players.

Highlights

Despite Mexico legislating a biosimilar regulatory framework in June 2009, the biosimilar pathway is still un-navigable. Nevertheless, going forward, due to the expensive nature of biosimilar development and approval, the new pathway will limit market access to only international players and the largest domestic companies.
For international producers Mexico represents an attractive market given manufacturing law reforms which have allowed international companies to expand into Mexico and the poor R&D facilities of domestic producers.
In 2011 there were 23 biosimilars registered on the Mexican market. This number is expected to swell following the ending to patents governing 10 global biologic blockbusters through 2012.

Your key questions answered

• What are the drivers and resistors to generic uptake in Mexico?
• What deal types are companies entering into when looking to enter or bolster their position in the Mexican generics and biosimilars market?
• Which branded biologics and small molecules are facing patent expiry in Mexico? Which provide a significant opportunity for biosimilar developers?

Table Of Contents

Executive Summary
Mexico – Introduction
Mexico – Strategic scoping and focus
Mexico – Datamonitor key findings
Generics market
Biosimilars market
Related reports

MEXICO – GENERICS MARKET OVERVIEW
Mexico – Generics market dynamics
Definitions – similares versus generics
Mexico generics volume uptake
Mexico generics value uptake
Mexico generics market size
Mexico – Generics drivers and resistors
The end of similares will drive growth in GIs
Increasing public sector health insurance together with government strategies will fuel generic usage
Consumers are increasingly turning to less expensive treatment options
Patent protection is strong in Mexico
Mexico chooses not to issue compulsory licenses
Mexican manufacturing law reforms have opened the door to the Mexican market
A new prescribing system will harm generic antibiotic producers
Mexico – Key generics players
Apotex’s success in Mexico is based on a localized business strategy
Sanofi looks to extend its presence in Latin America
Dr Reddy’s receives a warning letter from the FDA over its Mexican manufacturing
Daiichi-Sankyo leverages Ranbaxy’s presence in the Mexican market to commercialize and distribute its portfolio
Foreign pharmaceutical companies have tapped into the Mexican market through M&A deals
Mexico – Opportunities for the generics industry

MEXICO – BIOSIMILAR MARKET OVERVIEW
Mexico – Drivers of biosimilar uptake
Mexico has a biosimilar regulatory framework
Mexican producers lack the R&D capabilities for more complex biosimilar development
Human growth hormones do not require a prescription in Mexico
Mexico – Approved biosimilars
Biosimilars marketed in Mexico
Mexico – Key biosimilar players
Mexico – Opportunities for the biosimilar industry
Biologic patent expiries in Mexico
Biosimilar MAbs and second-generation biosimilars offer the greatest commercial potential

MEXICO – BIBLIOGRAPHY
Publications and online articles
Datamonitor reports and products

APPENDIX
Exchange rates used in this report
About Datamonitor