November 3, 2014

The RAND Corp. projected that the introduction of biosimilar drugs in the United States will reduce direct spending on biologics by $44.2 billion from 2014 to 2024.

 

October 17, 2014

A new study published Thursday by the Center for Healthcare Supply Chain Research identifies factors, based on an analysis of European models, that may affect the American launch of biosimilars and their marketplace potential in the United States.

October 15, 2014

Could the regulatory and scientific logjam that’s keeping copycat biotech medicines off the market and out of the hands of patients and health providers in the United States finally be breaking?

October 15, 2014

What’s in a name? A lot, apparently, if the name applies to a biosimilar medicine.

October 8, 2014

Pending legislation in the Pennsylvania state legislature is raising the eyebrows of several industry members, including the National Community Pharmacists Association, which stated that the legislation in its current form would "severely limit access to more affordable medications, vastly increase overall healthcare costs to Pennsylvania businesses and citizens and add cumbersome reporting requirements on healthcare providers."

September 29, 2014

According to a report released Monday by Thomson Reuters BioWorld, currently there are 700 follow-on biologics therapies moving through pipelines with many already approved.

September 24, 2014

In celebration of the 30th anniversary of the enactment of the Drug Price Competition and Patent Term Restoration Act, also known as the “Hatch-Waxman” Act, the National Association of Chain Drug Stores issued a statement to reflect on the evolution of providing patient access to generic medications and noted that it is looking forward to further progress in the years ahead.

September 10, 2014

The Food and Drug Administration recently announced the availability of the “Purple Book,” which lists biological products in much the same way that the "Orange Book" lists pharmaceuticals. 

September 2, 2014

The asthma treatment market value will grow from approximately $15.9 billion in 2013 across eight major countries — the United States, United Kingdom, France, Germany, Spain, Italy, Japan and Australia — to $23.1 billion by 2023, according to research and consulting firm GlobalData.

August 21, 2014

Restricting access to samples of generic biological drugs would lead to nearly $140 million in lost savings for every $1 billion in biologics sales, Matrix Global Advisors said.

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.