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.

March 25, 2014

Sales of specialty medicines are shifting toward hospitals and specialty pharmacies and away from independent physician owned-and-operated clinics, according to a report released Tuesday by HDMA's non-profit research foundation, The Center for Healthcare Supply Chain Research.

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 18, 2014

From 2012 to 2017, global spending on medicines will increase from $205 billion to $235 billion, according to IMS Health. By 2017, 36% of the spend will be on generics, a number that is 9% more than the percentage in 2013.

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.

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.

February 3, 2014

Mylan on Monday announced that its subsidiary has launched the world's first trastuzumab biosimilar in India, which will be marketed by Mylan as Hertraz.

January 31, 2014

Actavis on Friday announced a realignment of its global strategic business structure to maximize the company's newly strengthened position as a leading specialty pharmaceutical developer, manufacturer and marketer, and to enhance Actavis' position for continued long-term growth.

January 31, 2014

The imminent entry of several companies — including big pharma, small biotech and generic participants — into the global biosimilars space will propel the market toward exponential growth. The market is expected to soar from $1.2 billion in 2013 to $24 billion in 2019, reported Frost & Sullivan in research released earlier this week.

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

Three drug makers are looking into buying Pfizer's branded-generics drug business, according to published reports.

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 17, 2013

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

November 26, 2013

Generic drug maker Hospira will have its investor conference next week, the company said Tuesday.

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.

November 12, 2013

Hospira had sales of $1 billion in third quarter 2013, the generic drug maker said.