March 11, 2013

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

March 8, 2013

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

February 28, 2013

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.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

February 5, 2013

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.

January 21, 2013

While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

January 17, 2013

The Food and Drug Administraiton has approved a drug for replacing clotting proteins in the blood for conditions in which patients have too little of them.

November 15, 2012

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


October 12, 2012

The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

August 30, 2012

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 29, 2012

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.

August 23, 2012

A division of Johnson & Johnson has started a late-stage clinical trial program for a drug for rheumatoid arthritis under a partnership with British drug maker GlaxoSmithKline.

August 17, 2012

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.

July 31, 2012

Following regulatory approval by the Food and Drug Administration's Center for Biologics Evaluation and Research, GlaxoSmithKline confirmed it has begun shipping the first lots of its 2012-2013 seasonal influenza vaccines to healthcare providers and Centers for Disease Control and Prevention distribution centers.

July 17, 2012

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

June 6, 2012

A generic drug maker in India and a German pharmaceutical company will collaborate to develop biosimilars.

May 31, 2012

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.

May 15, 2012

Legislation proposed in the House of Representatives would speed up Food and Drug Administration approval of knock-off versions of vaccines and other biologics while requiring the agency to conduct more inspections of drug factories overseas, according to published reports.

May 11, 2012

Biotech drug maker Amgen has joined the list of companies offering testimony at a Food and Drug Administration hearing on biosimilars Friday.

May 9, 2012

The Food and Drug Administration should apply consistent regulatory standards across all biologics, Sandoz plans to state Friday in testimony at an FDA public hearing on draft guidances related to the development of biosimilars.

February 9, 2012

The Food and Drug Administration reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.

January 20, 2012

With the patent cliff and subsequent innovation drought moving closer, generic drug makers are looking to move up the value chain and pursue new sources of revenue, and of all the piles of pay dirt out there, biosimilars represent one of the closest things to an El Dorado, though regulations won’t take their final form for a while.


January 3, 2012

Drug maker Amgen will discuss the supplemental biologics license application of Xgeva before a Food and Drug Administration review panel next month.

December 23, 2011

Baxter and Momenta have agreed to partner to develop and market biosimilar drugs to treat cancer, autoimmune disorders and other chronic conditions.