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reached a major milestone on the path to a regulatory regime for follow-on biologics on Thursday with the release of draft guidance on biosimilar product development.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

One analysis report after another seems to confirm that the generic drug market is in for a huge shift as the number of blockbuster drugs losing patent protection is set to dwindle over the next several years. A recent report by Frost & Sullivan seems to confirm that sentiment.

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 19, 2012

Drug maker Sandoz has started two late-stage clinical trials of biosimilar drugs for treating cancer patients undergoing chemotherapy, the company said Thursday, saying the studies were meant to support the drugs' eventual marketing in the United States.

January 18, 2012

Patent expirations of key blockbuster drugs and efforts by payers to contain costs are likely to bring strong growth to the global generic drug market in the next few years as market-earned revenues grow by more than $100 billion, according to an analysis by research firm Frost & Sullivan.

January 10, 2012

Generic drug maker Hospira has enrolled the first patient in a late-stage clinical trial of a biosimilar drug for treating kidney disease.

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.

December 20, 2011

Generic drug maker Watson and biotech manufacturer Amgen will work together to develop biosimilar antibodies for treating cancer, the two companies said.

November 17, 2011

The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.

October 31, 2011

Watson Pharmaceuticals and a partnering company are barred from launching a generic version of a blood-thinning drug under a federal court decision issued Friday.

September 12, 2011

It’s hard to disagree that generic drug companies have had a good run for the last several years. Branded drug companies developed a large number of drugs that proved highly effective at treating widespread medical conditions and became blockbusters, garnering billions of dollars in sales in the United States alone.

September 1, 2011

The Food and Drug Administration has approved a new use for a follow-on biologic made by Sandoz.

August 18, 2011

With the global biosimilars market expected to expand nearly sixfold by the middle of the decade, market research firm IMS Health is launching a market-measurement tool for drug makers interested in getting into the space, the company said.

June 20, 2011

The overall growth in drug spending for 2010 was 3.7%, according to the latest drug trend report by pharmacy benefit manager Medco Health Solutions. The lower increase 
was primarily due to higher rates of generic drug dispensing — more than 71% of drugs dispensed were generics. 


June 13, 2011

Merck will collaborate with a Korean manufacturer to develop a biosimilar version of a drug used for autoimmune diseases.

May 18, 2011

Global spending on medicines will reach nearly $1.1 trillion by 2015, according to a new study by market research firm IMS Health.

May 13, 2011

The Generic Pharmaceutical Association and other trade and patient advocacy groups can push generic drug usage as a way to save on medical costs, but throwing the weight of Congress behind generics gives them a bigger boost than ever.

May 9, 2011

The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

May 4, 2011

Novartis is making big investments in biosimilars, CEO Joe Jimenez said in an interview with Fortune magazine.

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.

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 17, 2011

The Obama administration’s proposed budget for 2012 contains an item that could change the game for biosimilars, according to published reports.

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.