A Brief on Biologics, Biosimilars and Bioethics

The November/December issue of AARP, The Magazine features excellent articles on "The New Miracle Drugs."
It inspired me to write this brief overview.

Biologics are produced by living organisms and are engineered to specifically target proteins involved in causing disease. Many studies support their effectiveness in prolonging life and relieving symptoms for cancers, autoimmune diseases and other serious illnesses.
- More than 300 biologics currently on the market
- Comprise 25 percent of new drugs approved by FDA
- Comprise 13 percent of FDA black-box-warning labels
- $1.2 million to develop
- 10 years in research and development
- Possible annual cost of use: $100,000 Avastin, $60,000 Rituxan, $32,000 Enbrel

Biosimilars essentially are generic biologics.
- No approval process in place at FDA
- 10 to 30 percent savings predicted by FTC
- $9 billion in possible Medicare/Medicaid savings over 10 years

Bioethics experts caution against the inequity of the benefits of biologic therapy being available only to those who can afford it.

"It is indisputable that any patient should have access to these drugs [biologics], regardless of income or insurance status."
— Ruth Faden, PhD, director of the Johns Hopkins Berman Institute of Bioethics

Issues and Answers

Citing the extraordinary cost of developing biologics, the pharmaceutical industry has requested 12 to 14 years of exclusivity before biosimilars could be released. The FTC released a report recommending a shorter period to encourage development of new drugs and bring down prices. AARP lobbyists claim that 3 years should be sufficient to recoup costs. The battle is on.

Current prescription-drug pricing protocols and increases in the number of uninsured and underinsured patients can make biologics unaffordable. The current reform environment also promises to put pressure on development and approval of expensive therapies. Greater emphasis on patient safety may also have an affect.

Biologics are saving and improving lives where there was no hope. As technology improves for targeting biologics, new applications will arise and safety will improve. If an FDA approval process and agreement on clearing the way for biosimilars can be achieved, we can begin to address affordability issues and bioethical issues of equity and access.

— Tom DeSanto

Source: AARP, The Magazine, November/December 2009: "New Miracle Drugs," Mary A. Fischer,
"What Price A Miracle," Sheree Crute. Image: www.pharmaceutical-technology.com