spacer
home > pmps > winter 2015 > common knowledge
PUBLICATIONS
Pharmaceutical Manufacturing and Packing Sourcer

Common Knowledge

Currently, estimates suggest that it costs well over $1 billion to take a drug from discovery to market, in a process taking, on average, 12 years, but potentially lasting as many as 16, or even 20. If the patent for a drug is filed in year one, normally it will expire 20 years later, allowing for just eight years of exploitation by its owner, or – in a worst case scenario – no time at all. Once the patent has expired, it becomes available to rival companies who are able to exploit the drug without having made any investment in its discovery or development. Thus, the product becomes a copycat drug or, more accurately, a generic drug.

Generic: The Unbranding of Modern Medicine reviews the evolution of the generic drug industry from a group of mid-20th century copycats into a surprisingly powerful set of multinational corporations still in existence in the 21st century. Somewhat regrettably for us in Europe, the book focuses its account on the social, political and cultural history of generic drugs in the US.

Over the past 20 years, generic drugs have become objects of great interest. They have expanded from taking less than 10% of overall market share to providing more than 80% of all the prescriptions filled in the US today. This is an evolution that neither stakeholders in healthcare, nor producers of drugs that are in patent, can afford to ignore. It is fair to say that without generic drugs in their present form, healthcare across the world would be considerably more expensive and, in many cases, unaffordable by national governments.

This deeply researched and annotated book traces the history of generic drugs from initial scandals surrounding the alleged bribery of an FDA official and the suppression of data by The Boots Company, to the present-day situation where generic drugs are regulated just as tightly by the FDA and EMA as their pre-generic counterparts. There is also coverage of the naming and branding of generic drugs and the argument over what constitutes a generic, as well as the science of similarity and significance of differences between generic drugs and their precursors.

In addition, the book examines the current regulatory situation – concentrating largely on the US – and talks about the paradoxes of generic consumption in the clinic, pharmacy and, eventually, the supermarket. The author also discusses the science and politics of the so-called ‘me-too’ drugs, and briefly evaluates the international generic scene. In the final conclusion, he reviews what he refers to as the crisis of similarity, starting with a debate on the controversial topic of biosimilarity – an issue presenting a novel challenge to regulators. Biosimilars are prime examples of what Professor Greene calls “the same but not the same” drugs, and he worries about whether the introduction of generic drugs paid for by the state heralds a future where the loss of individual choice, market incentives, innovation and creativity will all be replaced by the embrace of the state.

It is rare for scientific treatises to be as readable and enjoyable as Generic: The Unbranding of Modern Medicine. I recommend the book to anyone interested in the past and future of generic pharmaceuticals.

Generic: The Unbranding of Modern Medicine by Jeremy A Greene is published by Johns Hopkins University Press. ISBN: 1-4214-1493-7

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer

Print this page
Send to a friend
Privacy statement
News and Press Releases

Amcor partners with Moda to offer innovative packaging solutions

Amcor is pleased to announce its partnership with Moda vacuum packaging systems in North America and Latin America. By combining Amcor’s shrink bag and rollstock film for meat and cheese with Moda’s system, producers can gain operational efficiencies and drive total cost savings.
More info >>

White Papers

What is process characterization?

EXPUTEC

Process characterization is an essential step in the commercialization of a new (biological) drug. For drug product commercialization, manufacturers must validate the drug’s manufacturing process. This ensures that the manufacturing process delivers consistently a quality product and that the patient is not at risk.
More info >>

 
Industry Events

Formulation and Drug Delivery Series UK

8-9 July 2020, Oxford Global

This event brings together leading formulation, drug delivery and biologics manufacturing experts from around the world across two days. The panel of prominent industry leaders and world-leading scientists will share the latest case studies, innovative developments for novel therapeutic products and strategies for drug development.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement