Regulatory

Part 2: Axinn Patent Attorneys Discuss Fallout From Challenges to the ACA

May 6th 2020

Ted Mathias and Stacie Ropka, PhD, patent attorneys and partners at Axinn, Veltrop, and Harkrider LLP, discuss past and future court decisions that leave the Affordable Care Act (ACA) in jeopardy and what could happen to the Biologics Price Competition and Innovation Act (BPCIA) as a result.

Part 1: Axinn Patent Attorneys Talk ACA Pushback and the BPCIA

May 4th 2020

Ted Mathias and Stacie Ropka, PhD, patent attorneys and partners at Axinn, Veltrop, and Harkrider LLP, discuss the overall pushback to the Affordable Care Act (ACA) and what that means for the Biologics Price Competition and Innovation Act (BPCIA).

Sanofi Insulin Biosimilar Gets CHMP Nod

May 1st 2020

By The Center for Biosimilars

The Committee for Medicinal Products for Human Use (CHMP) has given its recommendation for the marketing authorization of Insulin aspart Sanofi.

Genentech's Misfire on Kanjinti Creates Opening

April 28th 2020

By Tony Hagen

Taking an abundance of time to file a motion to block Kanjinti from coming to market, Genentech unwittingly may have tipped the scales in favor of biosimilar applicants.

Wong Discusses Strength of Regulatory Actions

April 23rd 2020

By The Center for Biosimilars

Ha Kung Wong, JD, a patent law attorney with Venable of New York, New York, discusses recent regulatory actions to promote biosimilars.

Biosimilarity Evaluations Should Be More Tailored

April 21st 2020

By Skylar Jeremias

A peer-reviewed study suggested that comparative efficacy trials are not always needed to determine efficacy equivalence for biosimilars, as data from pharmacokinetic (PK) studies and in vitro functional assays may suffice.

The Top 5 Biosimilars Articles for the Week of March 30

April 3rd 2020

The Center for Biosimilars® recaps the top stories for the week of March 30, 2020.

New Rule: Matt Harman Talks About Employer Interest in Biosimilar Promotion

March 26th 2020

Matt Harman talks about employer interest in biosimilar promotion and how the FDA's new biologics pathway change will affect interest levels, during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Wayne Winegarden, PhD, Explains the Impact of the BPCIA Regulatory Change

March 24th 2020

Wayne Winegarden, PhD, talked about the issues and benefits of the FDA's switch to a biologics regulatory pathway for certain products, especially insulin, during the World Biosimilar Congress USA 2020 at the Festival of Biologics USA in San Diego, California.

Sheila Frame Discusses Biosimilar Policy Developments and Market Impact

March 17th 2020

Sheila Frame, the vice president of marketing, market access, and patient services at Sandoz, discusses US biosimilar policies in development and the impact they will have on the market at the World Biosimilar Congress 2020 at the Festival of Biologics USA in San Diego, California.