Regulatory

It's a New Set of Rules for Insulin Products Under 351(k)

June 15th 2020

By Tony Hagen

Lannett’s insulin glargine biosimilar candidate will break new ground as it moves through the 351(k) review pathway, according to Ha Kung Wong, an intellectual property law attorney with Venable of New York.

Lannett Is Confident After FDA Insulin Glargine Meeting

June 12th 2020

Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.

FDA Approves Pfizer Pegfilgrastim Biosimilar Nyvepria

June 11th 2020

By Tony Hagen

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

Part 2: Kolodziej Discusses Biosimilar Support at NCCN Conference

June 11th 2020

By Skylar Jeremias

Although biosimilar uptake has been slow in the United States, the current administration has enacted several policies to help speed up the process, according to Michael Kolodziej, MD, who presented at the National Comprehensive Cancer Network (NCCN) 2020 Virtual Conference.

Canada Grapples With Drug Price Escalation

May 21st 2020

By Tony Hagen

In July 2020 Canada will implement a series of reforms to help bring runaway drug prices under control, panelists said at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

Study Shows Variations in RWE Citation Frequency

May 20th 2020

By Skylar Jeremias

Real world evidence (RWE) was cited differently depending on a number of criteria, leaving the door open to future research on how RWE influences payer decision making for specialty drug plans, said presenting author, Ari Panzer, at the Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

International Reference Pricing Gets Thumbs-Down From ISPOR Panel

May 18th 2020

By Tony Hagen

There’s not enough study of the effects of international reference pricing, but it is likely to stifle innovation and create access problems, according to an expert panel at Virtual ISPOR 2020, the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research.

Part 2: Modifications Could Help India's Biosimilars Powerhouse

May 14th 2020

By Skylar Jeremias

Although India is far ahead of other countries in terms of biosimilar approvals, its regulatory structure may hinder efforts for international sales.

Part 1: India Works on Guidelines for Biological Products

May 13th 2020

By Skylar Jeremias

India entered the biosimilar market early and has nearly 100 approved biosimilars, but experts say its regulatory system is not considered world-class, which may hinder international marketing of these products.

FDA's Drug Approval System Is More Open Than Australia's

May 11th 2020

By Tony Hagen

Australia’s secretive drug approval system gives what some believe is an unfair advantage to rival drug companies.