Biogeneric drugs are generic versions of biological drugs. They are also known as biosimilars and follow-on biologics.
There is no approval pathway for biogenerics in the U.S. although several have been approved in Europe.
The first biogeneric drug to be approved in Europe was Sandoz’ human growth hormone Omnitrope. Other approved biogenerics Binocrit developed by Sandoz; Epoetin alfa Hexal, from Hexal Biotech; and Abseamed from Medice Arzneimittel Putter—all generic versions of Johnson & Johnson’s anemia blockbuster Eprex., which is used to treat anemia associated with kidney disease and cancer therapy.
Biologic drugs are derived from living organisms and are typically used to treat serious diseases such as cancer, HIV and AIDS and Alzheimer’s disease. Because they are made from living organisms, they are typically extremely expensive to produce and purchase.
Examples include lung cancer drug Avastin, which costs about $100,000 per year; and Cerezyme, used to treat Gaucher disease, can run $300,000 or more per patient per year. Many patients simply cannot afford these prices.
Around 150 biologic drugs are on the market but many are close to losing their patent protection, which means that were there an approval pathway, much cheaper biogeneric products could enter the market and be available for consumers.
Some estimates say that by 2012, almost half of approved biologic drugs will have lost their patent.
Opinions about biogeneric drugs are mixed.
The Generic Pharmaceutical Association (GPhA) supports them and points out that various studies estimate savings from $42 billion to $108 billion over the first 10 years of a biogeneric market formation.
Others, typically the biologic manufacturers and the Biotechnology Industry Organization (BIO), do not. Even the FDA says that biosimilars cannot be approved easily because they are not exact replicas of biologic products.
At stake is that many people and organizations believe that a biological drug cannot be exactly replicated because it is a living organism. Others say that because of this, biogeneric drugs should be approved on a case-by-case basis.
What is clear is that if an approval pathway is created for biogeneric drugs, they will need to be very carefully monitored.
However, an approval pathway could be on the horizon. President Obama’s 2012 budget includes measures for biogenerics and the creation of an approval pathway.
Another issue regarding biogeneric drugs is the exclusivity period that’s granted to biologic drugs. These drugs are granted 12 years of exclusivity on the market, which the GPhA states is too much and BIO believes is too little. Traditional generic drugs can be approved in as little as five years.