Business

Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says

June 25th 2020

By Deana Ferreri, PhD

Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.

A Word From the Experts: The US Biosimilar Market Today and Onward

June 23rd 2020

By Skylar Jeremias

This spring, The Center for Biosimilars® interviewed a variety of thought leaders for their opinions on the US biosimilar market so far in 2020 and the barriers that need to be addressed. Here are some highlights.

Plaintiffs Suing AbbVie Have Until June 29 to Decide Whether to Continue Class Action

June 22nd 2020

By Allison Inserro

The judge in the Humira case, while noting that the patents have made it nearly impossible for rivals to gain a foothold, said the suit did not constitute a valid antitrust claim.

China's NMPA Approves Innovent's Byvasda Biosimilar

June 19th 2020

By Skylar Jeremias

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

Criticism Dogs Launch of Trade Agreement

June 17th 2020

By Deana Ferreri, PhD

The United States–Mexico–Canada Agreement came to a rocky impasse over drug exclusivity protections, and July 1 is the day this agreement takes effect.

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.

Biosimilar International Business Roundup: May 2020

June 2nd 2020

By Skylar Jeremias

Although the coronavirus disease 2019 pandemic continues to hamper the pharmaceutical industry, it hasn’t stopped companies from continuing to make deals, seek approvals, and conclude clinical trials.

Tufts Study: Most Payers Don't Give Preference to Biosimilars

May 21st 2020

By Tony Hagen

A study of coverage decisions by some of the nation’s largest payers indicates biosimilars get preferred status just 14% of the time.