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 honor of the 30th anniversary of the Drug Price Competition and Patent Term Restoration Act — more commonly known as the Hatch Waxman Act — which enabled manufacturers to bring generic versions of pharmaceuticals to market more easily, GPHA president Ralph Neas issued a statement.

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 23, 2014

A bill has been introduced that lawmakers say would “close federal loopholes” and increase consumer access to generic drugs while boosting market competition.

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. 

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The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved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 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

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 15, 2014

The Generic Pharmaceutical Association lobbied for greater access to generics at this week’s meeting of the chief negotiators of the Trans-Pacific Partnership in Ho Chi Minh City, Vietnam, the association announced Wednesday.

May 14, 2014

The Food and Drug Administration moved one step closer to establishing a biosimilar pathway with a new guidance document explaining how to use clinical pharmacology data to show similarity to a reference product, according to a report published by Regulatory Focus on 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.

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.

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 27, 2014

In lead-up to a House Panel hearing on Thursday, the National Association of Chain Drug Stores submitted a statement expressing its support for the leadership and efforts of Congress and the Food and Drug Administration in taking common-sense approaches in safeguarding the process of delivering prescription medications to patients.