Regulatory

Biorationality: A Dr Sarfaraz Niazi Column—A New Perspective on Biosimilars' Role Within Big Pharma

March 13th 2023

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz K. Niazi, PhD, explained why Indian manufacturers aren’t bringing biosimilars to the United States and how FDA policies and procedures discourage global companies from pursuing US market entry.

Eye on Pharma: FDA, EMA Accept Biosimilar Applications; Biosimilar Trials Begin

March 9th 2023

By Skylar Jeremias

Article

The FDA and the European Medicines Agency (EMA) accepted applications for a trastuzumab biosimilar and an ustekinumab biosimilar, respectively, and Altos Biologics completed patient enrollment for a phase 3 trial assessing an aflibercept biosimilar.

Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 2

March 7th 2023

By Ivo Abraham, PhD

Article

In part 2 of this 2-part series, Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, continued to examine guidelines from the World Health Organization (WHO) and how they view interchangeability and animal study requirements.

FDA Approves Autoinjector Version of Neulasta Biosimilar

March 6th 2023

By Skylar Jeremias

Article

The FDA approved the prefilled autoinjector version of Coherus Biosciences’ pegfilgrastim biosimilar (Udenyca), which will allow for patients at risk of febrile neutropenia to administer a full dose of pegfilgrastim at home.

Dr Ivo Abraham Column: The 2022 WHO Biosimilar Guidelines—Loosening the Reins or Changing the Track? Part 1

February 28th 2023

By Ivo Abraham, PhD

Article

Ivo Abraham, PhD, chief scientist of Matrix45 and a professor at the University of Arizona, details how biosimilar guidelines from the World Health Organization (WHO) have changed over time and whether those changes are beneficial for biosimilars in part 1 of this 2-part series.

BioRationality: A Dr Sarfaraz Niazi Column—Avoid Delays in Biosimilar Approvals Due to CRLs

February 27th 2023

By Sarfaraz K. Niazi, PhD

Article

Although a complete response letter (CRL) is not an official rejection letter, it can result in approval delays by listing out shortcomings in an application and giving companies an opportunity to respond. In his latest column, Sarfaraz K. Niazi, PhD, goes over how companies can avoid these approval postponements.

Access 2023: FDA’s Dr Jacqueline Corrigan-Curay Gives Updates on Biosimilar, Generic User Fee Programs

February 22nd 2023

By Skylar Jeremias

Article

Jacqueline Corrigan-Curay, MD, JD, principal deputy center director of the FDA's Center for Drug Evaluation and Research, gave a keynote presentation at Access 2023 on how the Biosimilar User Fee Act and the Generic Drug User Fee Act have developed over the last year.

IGBA Panelists Discuss the Global Reputation of Biosimilars, Generics

February 21st 2023

By Skylar Jeremias

Article

Panelists at the annual meeting of the International Generic and Biosimilar Medicines Association (IGBA) offered insight into the current state of the global biosimilar and generic markets and why government agencies need to leverage these medicines to address challenges in the pharmaceutical space.

The Top 5 Biosimilar Articles for the Week of February 13

February 17th 2023

By Justina Petrullo

Video

Here are the top 5 biosimilar articles for the week of February 13, 2023.

Fresenius Kabi Launches Stimufend in the US

February 16th 2023

By Skylar Jeremias

Article

Fresenius Kabi announced the US launch of its pegfilgrastim biosimilar Stimufend (pegfilgrastim-fpgk), making it the fifth biosimilar referencing Neulasta to enter the market.