Legal

Senator Introduces Bill to Rid Switching Study Requirements for Interchangeability

November 22nd 2022

By Skylar Jeremias

The Biosimilar Red Tape Elimination Act will seek to increase patient access to biosimilars by reducing switching study requirements for companies to obtain interchangeability designations.

Eye on Pharma: Natalizumab Injunction; Oral Ustekinumab Development; New Study for Secukinumab Biosimilar

November 10th 2022

By Skylar Jeremias

Article

As the US awaits the 2023 launch of adalimumab biosimilars, Biogen announces an injunction against Sandoz over a natalizumab biosimilar, Rani Therapeutics initiates a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions begins a phase 3 trial for a secukinumab biosimilar.

Deal Would Have Teva Pay $4.25 Billion to Settle US Opioid Lawsuits

July 27th 2022

By The Center for Biosimilars

Article

The deal follows a string of trials and settlements totaling $550 million in separate cases around the country.

Contributor: The Trouble With IP for Digital Health and Precision Medicine

July 18th 2022

By Ha Kung Wong, JD

Article

Two experts in biosimilar intellectual property (IP) law break down the issues that digital health and precision medicine face with IP and the history of case law that has created the current landscape.

Contributor: No Animal Testing of Biosimilars—US Congress Begins Amendment to BPCIA

June 27th 2022

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, a professor and biosimilar advocate, chronicles the current efforts to remove animal testing from application requirements for biosimilars under the Biologics Price Competition and Innovation Act (BPCIA), including recent congressional action.

Pfizer Settles 2 Lawsuits, Starts Another Over Etanercept Biosimilar in Australia

May 16th 2022

By Skylar Jeremias

Article

After agreeing to settle with Amgen over its oncology biosimilars, Pfizer issued a new patent lawsuit against 5 companies over the development of Brenzys, an etanercept biosimilar, in Australia.

The US Is Entering Round 2 of Biosimilar Activity, Says Cardinal Health’s Oskouei

May 3rd 2022

By Laura Joszt

Article

The United States is about to enter round 2 of biosimilar activity with a pipeline that expands biosimilars into new therapeutic areas, said Sonia Oskouei, PharmD, BCMAS, DPLA, vice president of biosimilars, Cardinal Health, during her presentation at Asembia’s Specialty Pharmacy Summit.

Jeffrey Casberg Discusses the Alvotech, AbbVie Settlement Over an Adalimumab Biosimilar

April 27th 2022

By Skylar Jeremias

Video

Jeffrey Casberg, vice president of pharmacy at IPD Analytics, discusses the Alvotech/AbbVie settlement for an adalimumab biosimilar and whether it will impact future patent lawsuits.

AbbVie Settles ITC Case With Alvotech; Humira Biosimilar to Launch July 2023

March 8th 2022

By Skylar Jeremias

Article

AbbVie settles outstanding lawsuits, including its case related to the International Trade Commission (ITC), with Alvotech, giving Alvotech the green light to launch its high-concentration, citrate-free adalimumab biosimilar referencing Humira in July 2023, pending FDA approval.

In Iceland, Switch to Adalimumab Biosimilar Reveals Issues With Injection Device

February 15th 2022

By Mary Caffrey

Article

Iceland’s national health plan required patients to switch from Humira to the Samsung Bioepis biosimilar, Imraldi, which had a different injection device and contained citrate, a chemical buffer used to maintain the medication’s stability.