July 22, 2015

Novartis will be able to introduce Sandoz’s Zarxio (filgrastim) after Sept. 2, the U.S. Court of Appeal for the Federal Circuit ruled Wednesday. 

June 5, 2015

The company is fighting an injunction that’s keeping Sandoz’s Zarxio from becoming the first biosimilar sold in the United States.

 
May 26, 2015

Specialized manufacturers are gearing up for a robust trade out of generic biosimilar approvals, Kalorama reported last week. 

April 16, 2015

According to the Food and Drug Administration, heart failure is a common condition that affects close to 5.1 million people in the United States. The condition arises when the heart cannot pump enough blood to meet the body’s needs. 

January 8, 2015

Sandoz may be on track to receive the first biosimilar drug approval from the Food and Drug Administration for its Zarxio.

November 20, 2014

Decision Resources Group found that sales of biosimilar versions of the granulocyte colony-stimulating factors (G-CSFs) filgrastim and pegfilgrastim could reach $1.8 billion in the United States by 2023. 

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

June 10, 2014

Amgen on Monday appointed David Meline as EVP and CFO, effective July 21.

May 6, 2014

Sandoz recently announced that the generic manufacturer continues to advance its biosimilars pipeline that currently has six molecules in the Phase III clinical trial/filing prep phase.

February 3, 2014

The Generic Pharmaceutical Association on Monday identified its key priorities for 2014 — guarding against confusion a proposed labeling change would cause; gaining access to biosimilar generics; and heralding the cost savings generated by generic utilization.

November 18, 2013

The global market for biosimilars is expected to be worth nearly $2 billion before the end of the decade, according to a new study.

October 29, 2013

In what is emerging as the latest battle over follow-on biologics, a new argument has emerged about what to call them, and supporters of biotechnology companies are the latest to take a shot.

October 22, 2013

Biotech drug maker Amgen has acquired from Roche the rights to drugs used to boost the immune systems of cancer patients on chemotherapy in 100 markets.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

August 27, 2013

Lawmakers in California have passed a bill that would restrict the use of follow-on versions of biotech drugs known as biosimilars, according to published reports.

August 26, 2013

Biotech company Amgen is buying Onyx Pharmaceuticals, the companies said Sunday.

August 20, 2013

Generic drug maker Sandoz has relaunched a website to promote its biosimilars business.

July 22, 2013

An announcement Monday by generic drug maker Sandoz gives a glimpse of what could happen in the United States when biosimilars start to become available.

July 9, 2013

Amgen will get rights to a drug for cardiovascular disease approved in the European Union under a new deal with French drug maker Servier, the two companies said.

July 2, 2013

Sandoz has started a late-stage clinical trial of a biosimilar version of a drug used to treat autoimmune disorders, hoping the results will support its efforts to win regulatory approval in the United States and Europe.

June 18, 2013

Royalty Pharma will not buy Irish drug maker Elan Corp., the company said Tuesday.

June 14, 2013

Irish drug maker Elan Corp. said Friday it was looking to sell itself off to a New York-based company that invests in drug royalties after rejecting a previous offer.

June 13, 2013

The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

June 3, 2013

Another bill to limit dispensing of biosimilars lost Monday, this time in Illinois.