U.S. Pharmacist



FTC Questions Years of Patent Protection for Biotech Drugs

By Staff


US Pharm. 2009;34(9):34-36. 

According to the Reuters news agency, a report issued by the Federal Trade Commission (FTC) said that generic versions of biotechnology drugs would reduce the amount of money spent on health care in the U.S. and has taken the position that 12 to 14 years of patent protection "is too long to promote innovation."

While the debate over whether generic versions of biotech drugs, also known as biosimilars, will ever be brought to market continues, the FTC believes that even if the FDA grants approvals for "similar" biotech products, it is likely that fewer generic manufacturers would enter this expensive marketplace with generic versions of these very costly branded biotech drugs. If that were true, it stands to reason that prices of generic biotechnology drugs would likely not be driven down to traditionally low generic pricing levels.

Despite this, because the drugs are so expensive, the cost savings could still be sizable and be a considerable benefit to the health care system. For this reason the FTC is standing firm in its opinion that the patent exclusivity period of branded biotech drugs should be shortened. 


U.S. Pharmacist is a monthly journal dedicated to providing the nation's pharmacists with up-to-date, authoritative, peer-reviewed clinical articles relevant to contemporary pharmacy practice in a variety of settings, including community pharmacy, hospitals, managed care systems, ambulatory care clinics, home care organizations, long-term care facilities, industry and academia. The publication is also useful to pharmacy technicians, students, other health professionals and individuals interested in health management. Pharmacists licensed in the U.S. can earn Continuing Education credits through Postgraduate Healthcare Education, LLC, accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education.

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