August 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

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.

July 16, 2014

RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications. 

July 2, 2014

As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.

June 25, 2014

Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration.

June 25, 2014

Pharmacists in Pennsylvania may soon be required to notify physicians prior to substituing a biologic medicine with a biosimilar medication following the passing of a bill by the Pennsylvania Senate, the Associated Press reported Tuesday.

May 7, 2014

The pace of annual global spending on oncology medicines — which is approaching the $100 billion threshold — has moderated over the past five years, even as a surge in innovative and targeted therapies has brought new therapeutic options to the growing number of patients being treated for cancer and as survival rates for most tumor types continue to increase, according to a new report released Tuesday by the IMS Institute for Healthcare Informatics.

April 14, 2014

The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

March 27, 2014

Indiana Governor Mike Pence earlier this week signed legislation designed to create a pathway for the substitution of interchangeable biologic medicines, according to published reports.

March 10, 2014

Although the United States is still waiting for final practical guidelines from the Food and Drug Administration about the launch of biosimilars and the standards required to meet the threshold of interchangeability, the rest of the world seems to be barreling forward with the development and launch of these important medicines.

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

January 31, 2014

The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

January 28, 2014

The Generic Pharmaceutical Association on Tuesday announced the hiring of Jonathan Marks as VP international affairs.

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

January 14, 2014

Drug maker Sandoz has started a late-stage clinical trial of a biotech drug used to treat autoimmune disorders, the company said.

December 26, 2013

Earlier this year, the IMS Institute for Healthcare Informatics, the research wing of the healthcare industry analysis firm IMS Health, dropped a bombshell when it showed that U.S. spending on drugs fell in 2012, the first time that had happened in 55 years.

December 23, 2013

The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.

December 17, 2013

Forty blockbuster drugs will use patent exclusivity in the United States between this year and 2020, according to a new study.

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 25, 2013

Three pharmacy groups are petitioning the World Health Organization to uphold common generic names for biosimilars and their branded reference products.

October 22, 2013

A top executive of generic drug maker Hospira spoke in favor of giving biosimilar drugs the same generic names as the branded biologics they're based on.

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.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.