GPhA urges FDA to support generic drugs

Approval of generic biopharmaceuticals would yield tremendous cost savings for America's healthcare system. There is currently an economic need for more affordable versions of biopharmaceuticals. Already, marketed biopharmaceutical products account for approximately $30 billion (€23bn) in US sales and 12 per cent of total pharmaceuticals. By 2010, sales are expected to exceed $60 billion.

The GPhA claimed that because of their exceedingly high costs, biopharmaceuticals would consume a greater percentage of healthcare expenditures in the future and substantially burden health care purchasers, including the federal government, employers and consumers.

According to GPha, the average cost to a major US employer for a one-day supply of biopharmaceutical drugs is $45, while traditional drugs cost an average of $1.66 per day. Generic medicines can cost up to 80 per cent less than their brand counterparts.

Affordable biopharmaceuticals, even if they represented only a modest savings of 10 per cent to 20 per cent would create billions of dollars in savings for consumers, the government and healthcare providers.

The GPhA​ can turn to the example of Zantac as evidence. Widely used as an ulcer treatment, in 1997, the patents for Zantac expired. Within weeks, generic competitors entered the market and gave consumers the choice between an $83 per prescription cost for the brand or approximately $12 for the generic. Within months, more than 80 per cent of prescriptions previously filled by the brand name drug were being filled with more affordable generic versions of the drug.

The term, generic biopharmaceuticals, is used to describe those drug treatments, which are generally large protein molecules derived from living cells. Examples include insulin, human growth hormone, antibiotics, and monoclonal antibodies.

During the FDA-Drug Information Association public forum held to examine the scientific issues behind generic biopharmaceuticals, scientists from the FDA and MIT acknowledged that the science exists to create and characterise generic biopharmaceuticals.

Branded drug marketers are understandably concerned about these latest developments. They argue that patent protection under its current form is necessary to fund research and development for new, innovative drugs. Without these efforts from the branded companies, generics companies wouldn't have a steady stream of products to copy. It seems in the best interest of all parties to strike a balance.

Pharmaceutical companies have taken measures to ensure equilibrium is met. Rather than fight these proposals, the trend now amongst the industry is to incorporate the generic factor into their overall corporate strategy, embracing its eventuality rather than avoiding the issue completely.

Sanofi-Synthélabo Group Generics, a newly created entity of the sanofi-aventis Group, was set up to distribute patent-free prescription products in Europe. It operates to offer a wide range of compounds identical to those of the original products whilst observing intellectual property rights. Its aim is to contribute cost savings for the patient.

Karen Katen, president of Pfizer Global Pharmaceuticals commented in the company's third-quarter 2004 performance report: "We manage our portfolio by protecting our assets."​

"Losses of exclusivity, for example, are particularly significant now and will affect several of our key medicines in the coming years."​

The report also said that after a compound loses marketing exclusivity, they would consider marketing a generic version in the US through Greenstone, its generics subsidiary acquired with Pharmacia.

While the United States is debating the manufacture of generic biopharmaceuticals, citizens of other nations are already enjoying access to more affordable generic biopharmaceutical products.

In October 2004, for example, Australia approved Sandoz human growth hormone drug Omnitrope, becoming one of the first countries to approve a biogeneric. News reports suggest the medicine could be approved by the European Union later this year.

The potential for savings is set to multiply over the next decade. Fifteen blockbuster drugs, with annual sales ranging from about $500 million to more than $6.6 billion each, are scheduled to lose patent or market exclusivity in 2004 and 2005.

An example is the prospect of generic versions of Pfizer's Norvasc (amlodipine). They are waiting for the end of patent protection for the best selling antihypertensive before hitting the shelves. To counter the threat, Pfizer is combining Norvasc with Lipitor to make its amlodipine treatment superior to the numerous generics likely to hit the market extend its sales life.

According to Cutting Edge Informtion, generics now account for more than 50 per cent of all prescriptions filled in the US and sales are projected to reach $60 billion by 2007.