Content about Biologic

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

CHICAGO — Generic drug maker Hospira marked its fifth year marketing knock-off versions of biotech drugs in Europe Wednesday as it presented at the 2013 Biotechnology Industry Organization International Convention this week.

The drug maker said it delivered more than 5 million doses of biosimilar medicines to patients in Europe and Australia. The convention includes multiple sessions devoted to such topics as biosimilar regulatory approval, manufacturing and market formation, the company said.

SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

WASHINGTON — Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago. But IMS Health and other industry experts agree it could still be years before biosimilars are available to pharmacies and patients in this country.

NEW YORK — A new report sheds light on some of the opportunities and challenges that exist in follow-on biologics, arguing that their opportunity to generate value depends on factors like the speed of development, clarity of regulation, ease of access and the roles of all stakeholders.

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

The drug maker said Friday that the FDA had approved Actemra (tocilizumab) for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to one or more disease-modifying antirheumatic drugs. The drug was already approved for systemic juvenile idiopathic arthritis.

WASHINGTON — A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

According to published reports, the panel voted 15-2 that the benefits of Humira outweighed the risks in treating ulcerative colitis. However, the panel asked Abbott to conduct more studies upon Humira's approval.

The U.S. healthcare system presents a paradox: It’s the most expensive system in the world, and yet it produces among the worst results among developed countries. According to the most recent report from the National Health Expenditure Accounts, spending on health care reached $2.6 trillion in 2010, or more than $8,400 per person and around 18% of the country’s gross domestic product.


HORSHAM, Pa. — A subsidiary of Johnson & Johnson is hoping to win an additional approval for one of its drugs.

Janssen Biotech and Janssen Biologics B.V. announced the submission of a supplemental regulatory application to the Food and Drug Administration for Simponi (golimumab) for treatment of moderately to severely active ulcerative colitis, an inflammatory bowel disease that affects about 700,000 people in the United States. The drug already is approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

WASHINGTON — As the Food and Drug Administration works to finalize draft guidance related to the development of biosimilar products, pharmacy groups recently weighed in with recommendations to facilitate the entry of lower-cost products into the biologic and specialty pharmaceutical markets.