March 29, 2011

Any manufacturer that has the necessary resources and still is hesitating about whether to tap into biosimilars might want to go ahead and do it, if projections by British market analysis firm Datamonitor come true.

March 3, 2011

The head of a group representing the nation's pharmacy benefit managers got honors from the Generic Pharmaceutical Association.

February 25, 2011

The Food and Drug Administration has declined to approve a biologic treatment for a rare genetic disorder by Israeli drug maker Protalix Biotherapeutics, Protalix said Friday.

February 25, 2011

Savient said its newest drug is the first and only therapy available to treat chronic gout in adult patients refractory to conventional therapy.

February 18, 2011

Though efforts to repeal the Patient Protection and Affordable Care Act via the court system remain under way — with recent victories for opponents in Virginia and Florida — the attempt to repeal the healthcare-reform bill in Congress failed, thus leaving the bill and, most importantly, the regulatory approval pathway for follow-on biologics intact.


February 14, 2011

An increase in consolidation among generic drug companies could be in the works, according to a new report from Thomson Reuters.

February 9, 2011

Sandoz is developing as many as 10 new follow-on biologics, according to published reports.

February 3, 2011

The former top executive of the Generic Pharmaceutical Association may have gone to work for the National Community Pharmacists Association, but the generic drug industry trade group got one of the independent pharmacy group’s executives as well.

February 1, 2011

As soon as members of Congress took their seats last month, the new Republican majority announced it would make good on its pledge to repeal the Patient Protection and Affordable Care Act. The effort largely is symbolic and unlikely to succeed, so at least one portion of the healthcare-reform law will likely remain in effect, namely the abbreviated approval pathway for follow-on biologics, also known as the Biologics Price Competition and Innovation Act.


February 1, 2011

Years 2009 and 2010 were up and down for the generic drug industry and its main trade group, the Generic Pharmaceutical Association. On one hand, there were the departures of president and CEO Kathleen Jaeger and member company Teva Pharmaceutical Industries.

January 10, 2011

PakSense has launched a small device for monitoring the temperatures of medicines, the company said Monday.

January 6, 2011

A U.S. biotech company plans to develop a biosimilar of a monoclonal antibody used to treat cancers and autoimmune disorders.

December 20, 2010

Drugs for bacterial infections and cancer, and one that could help shape regulations for biosimilars, are featured in the Food and Drug Administration’s annual "Generic Drug Roundup."

December 13, 2010

Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.

December 7, 2010

Drug makers Momenta Pharmaceuticals and Sandoz have filed a lawsuit against Teva Pharmaceutical Industries in the U.S. District Court for the District of Massachusetts, alleging infringement of two patents related to a generic blood-thinning drug.

November 30, 2010

Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

November 14, 2010

William Gibson, the science-fiction author who helped create the cyberpunk genre in the 1980s and...

November 9, 2010

To express it in modern parlance, follow-on biologics will be a hot mess....

November 2, 2010

The main lobbies for the biotechnology and generic drug industries, and a leading manufacturer of...

November 1, 2010

Amgen's SVP research and development, Joe Miletich, urged members of a Food and Drug Administration...

November 1, 2010

In testimony before the Food and Drug Administration on Tuesday, CVS Caremark’s SVP specialty pharmacy...

November 1, 2010

The Food and Drug Administration should ensure patient access, safety and efficacy; create a transparent...

October 4, 2010

Human Genome Sciences and Novartis have decided not to further develop an investigative biologic treatment...

September 26, 2010

Biosimilars, biogenerics, follow-on biologics—whatever the designation one prefers for knockoffs of biotech drugs—they will soon...