A Primer on Follow-On Biologics
By: Bryan A. Liang, MD, PhD, JD E.
Donald Shapiro Distinguished Professor; Executive Director, Institute of Health Law Studies, California Western School of Law; and Co-Director, San Diego Center for Patient Safety, UCSD School of Medicine
Biologic drugs are today's most advanced medicines. These complex medicines are biotechnology drugs tested through clinical trials that provide therapy to victims of cancer and other diseases.
Biologics represent the fasting-growing sector in the medicines market, with more than $30 billion spent on these drugs each year. Indeed, the top five drugs in terms of Medicare expenditures administered in physicians' offices are biologics. By 2010, worldwide spending on biologics is estimated to grow to $100 billion, and biologics will make up nearly half of all newly approved medicines.
"Follow-on" biologics are attempted copies of the original biologic drugs by manufacturers other than the original developer of the biologic drug. However, although they are similar to the original, follow-on biologics are not identical. Read more...
Avoiding No Man's Land: New Deloitte Study on Follow-on Biologics Investigates Proposed Legislation and Possible Unintended Consequences
Deloitte released a study, Avoiding no man's land: Potential unintended consequences of follow-on biologics, that explores the debate on creating a regulatory pathway for the approval of follow-on biologics (FOBs), drugs that are envisioned as the biotech equivalent of generic pharmaceuticals. The study examines two bills that have recently been introduced in Congress, both based on the model of the Hatch-Waxman Act of 1984. The Deloitte study also outlines unintended effects of the Hatch-Waxman legislation and explores how this experience may help guide current legislation.
"At the crux of the argument is how opening a regulatory pathway for FOBs can be accomplished while maintaining patient safety, and without destroying the incentives necessary to attract investment into the next generation of breakthroughs," said Jim Hollingshead, Principal, Deloitte Consulting LLP, in their Health Sciences practice, who lead the study. Read more...
Familia Unida - Living With Multiple Sclerosis
The mission of Familia Unida Living with Multiple Sclerosis is to Enlighten, Educate, and Unite Families affected by Multiple Sclerosis and other debilitating diseases in our culturally diverse communities and to offer support services to diverse populations that request our attention. It is our ethical responsibility to promote awareness of the growing number of individuals afflicted by MS and provide culturally sensitive programs. We advocate for preservation of cultural diversity and enhancement of the quality of life.
Familia Unida Living with Multiple Sclerosis was founded in 1998 on the philosophy that their was a need for culturally sensitive programs and services for individuals and families dealing with the complications of MS. Although the agency was originally founded to serve the needs of the Latino MS community, it has grown into a "safe haven" for everybody with and/or concerned about MS. The constituency of the organization is a rainbow of races, cultures, ethnicities, ages and social statuses.
May 6, 2009
A Health Forum About Diabetes
12:00 - 2:00 PM
Table 260 Downtown
826 J Street, Sacramento, CA 95814
Please RSVP to Sharon Bacon at (916) 498-1890 or e-mail email@example.com
May 26, 2009
12:00 - 2:00 p.m.
Los Angeles Area Chamber of Commerce
Bank of America Room
350 S. Bixel Street, Los Angeles, CA 90017
Complimentary subterranean parking located on 4th Street side of the building.
Please RSVP to Arlen at (323) 466-3445 or e-mail firstname.lastname@example.org
May 27, 2009
12:00 - 2:00 p.m.
Santa Clara Convention Center
5001 Great America Parkway, Santa Clara, CA 95054
Complimentary parking available
Please RSVP to Charlotte at (916) 658-0144 or e-mail email@example.com
Check out our CPAT partner events occurring this month!
CPAT Partners in the News!
Black Barbershop Health Outreach Program - Newsweek
Meet Each Need with Dignity - Los Angeles Daily News
Meet Each Need with Dignity - Good Morning America
Sacramento Native American Health Center - Sacramento Bee
Would you like to share your news story? Contact Charlotte Phillips at firstname.lastname@example.org and your organization's news story can be featured in our next edition of CA Access News.
Swine flu: San Francisco biotech company races to develop vaccine
San Jose Mercury News, May 2, 2009
A new generation of scientists, frustrated by a technology that hasn't changed in decades, is seizing the chance to test faster ways to battle the bug. They hope their new tools can design a vaccine in time to combat the current outbreak; if not, they want to be ready when it returns -- or if there's an outbreak of a far worse pathogen. Read more...
Bay Area is rich in biotech companies
San Francisco Chronicle, April 29, 2009
If you live in the Bay Area, chances are good that you're close to a company with biotechnology ties. The Bay Area, where the biotech industry was born in the 1970s, remains the world's largest cluster of biotech enterprise. Read more...
Bill would give FDA power to OK biogeneric drugs
Los Angeles Times, March 12, 2009
A bipartisan group in Congress wants to give the Food and Drug Administration power to approve copies of costly biotech drugs. Rep. Henry A. Waxman (D-Beverly Hills), chairman of the House Energy and Commerce Committee, and Rep. Nathan Deal (R-Georgia) introduced legislation to create a pathway for the approval of copies of biotechnology-based medical treatments. Biotech drugs are made in living cells, unlike their chemical-based counterparts. Read more...
Obama calls for generic biotech drugs
San Diego Union-Tribune, February 27, 2009
President Barack Obama's budget aims to foster generic competition for costly biotech drugs used to treat cancer and other intractable ailments. With Americans now spending more than $40 billion a year on such medications, the budget calls on Congress to set up a framework for regulators to approve generic versions, cutting costs for government programs, employers and patients. Read more...
Innovation by the Numbers
Pharmaceutical discovery has benefited from a remarkable revolution in technology, from its early beginnings with the introduction of aspirin to the discovery of drugs that target specific genes that cause disease. Today, pharmaceutical innovation looks very different than it did 100 years ago, 50 years ago, or even just 10 years ago. Below are statistics and information regarding the innovation of new medicines and their development:
10-15 = Number of years required to make a medicine 
$58,800,000,000 = Spending on research and development of new medicines by pharmaceutical companies in 2007. 
$1,300,000,000 = Average cost to develop one medicine. This amount is up from $138 million in 1975, $318 million in 1987, and $802 million in 2000 (2005 dollars) 
2 out of 10 = Number of new medicines that produce revenues that match or exceed average research and development costs 
Over 2,700 = Number of medicines in development 
Nearly 350 = Number of new medicines approved between 1997 and 2006 
50-60 percent = Portion of cancer survival increases attributable to new medicines 
70 percent = Decrease in AIDS death rate since advent of new medicines in 1995 
10 cents = Portion of every dollar spent on health care that goes to prescription medicines 
To learn more about pharmaceutical innovation and these statistics, please visit http://www.innovation.org.
- J. A. DiMasi, "New Drug Development in the United States from 1963 to 1999," Clinical Pharmacology and Therapeutics 69, no. 5 (2001): 286-296.
- Burrill & Company, analysis for Pharmaceutical Research and Manufacturers of America, 2008; and Pharmaceutical Research and Manufacturers of America, PhRMA Annual Member Survey (Washington, DC: PhRMA, 2008).
- J. A. DiMasi and H. G. Grabowski, "The Cost of Biopharmaceutical R&D: Is Biotech Different?" Managerial and Decision Economics 28 (2007): 469-479.
- J. Vernon, J. Golec, and J. DiMasi, "Drug Development Costs when Financial Risk is Measured Using the Fama-French Three Factor Model," Unpublished Working Paper, January 2008.
- Adis R&D Insight Database, 27 February 2008, and Adis R&D Insight Database customized run, December 2005.
- Pharmaceutical Research and Manufacturers of America, "Pharmaceutical Industry Profile 2003: New Medicines. New Hope." (Washington, DC: PhRMA, 2003)
- FDA Office of Orphan Products, 26 April 2006 http://www.fda.gov/orphan/designat/list.htm
- U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, Health, United States, 2005 With Chartbook on Trends in the Health of Americans (Hyattsville, MD: NCHS, 2005), http://www.cdc.gov/nchs/data/hus/hus05.pdf (22 December 2005).
- C. Smith et. al., "National Health Spending In 2004: Recent Slowdown Led By Prescription Drug Spending," Health Affairs 25, no. 1 (2006): 186-196.