Tony Hagen

March 16, 2020

Supplies of active pharmaceutical ingredients (API) are difficult to track and anticipate owing to limited information that manufacturers are required to provide, an issue that can make it difficult to respond to the COVID-19 pandemic, according to an interview with a Vizient executive.

March 14, 2020

Seen up close, many patents are not truly strong enough to block biosimilar commercialization, although patents filed after FDA approval of originator products can bar access to modern manufacturing methods, according to Hans Sauer, deputy general counsel and vice president for intellectual property at the Biotechnology Innovation Organization (BIO).

March 13, 2020

In light of the COVID-19 outbreak, the FDA has suspended foreign inspections of FDA-regulated manufacturing plants and products. Meanwhile, escalating foreign travel restrictions put a damper on growth of the biosimilars industry.

March 12, 2020

Stakeholder comments at a biosimilars forum staged by the FDA and Federal Trade Commission focused on improving the quality of information being disseminated about biosimilars and the need to make the approval process less burdensome for manufacturers.

March 09, 2020

The conference was designed to further collaborative efforts between the FDA and the Federal Trade Commission (FTC) and generate public confidence in regulators’ commitment toward fostering a healthy biosimilars marketplace, but the goal is not to put manufacturers of innovator biologics on edge, said Stephen M. Hahn, commissioner of the FDA.

March 08, 2020

The FDA granted the application for the biosimilar to Avastin a decision date of December 27, 2020.

March 04, 2020

Katie Verb, director of policy and research for the biopharmaceutical industry group PhRMA, discusses recent policy changes that have increased biosimilar uptake and additional measures that could lead to greater use of biosimilars and savings for CMS and patients.

March 03, 2020

The US biosimilars market is showing healthy vital signs, said Leah Christl, Amgen’s executive director for global regulatory and research and development policy, in a talk kicking off the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California, while also reassuring the audience that her former FDA colleagues are still champions of their work.

February 14, 2020

Sarfaraz K. Niazi, PhD, a pharma industry veteran and consultant for biosimilar makers, discusses ins and outs of the approvals process that cause frustration and unnecessary expense.

February 11, 2020

The orphan drug market could see hefty biosimilar competition, based on revenue potential, and patent struggles need to be resolved before some biosimilars can come to market, according to a speaker reviewing the 2020 pipeline at the Specialty Therapies and Biosimilars Congress.