Regulatory

Interview: Understanding the Attraction for PD-1 Inhibitor Biosimilars

October 13, 2020

Tony Hagen

Years ahead of patent expirations for programmed death-1 (PD-1) inhibitors, biosimilar companies have begun focusing on these targeted drugs.

Study: Efficacy Trials Cost More, Take Longer for Biosimilars Than Originators

October 10, 2020

Skylar Jeremias

Article

Average clinical efficacy testing cost millions of dollars more for phase 3 biosimilar studies than for pivotal studies of originator products, authors report.

International Presenters Share Tips on Beefing Up Biosimilar Use

October 9, 2020

Skylar Jeremias

Article

As the United States continues to struggle to increase biosimilar uptake, presenters at the DIA 2020 Biosimilars Conference offered insight into what other countries have done to encourage biosimilar use.

UK Regulators Seek Response on Waiving Comparative Efficacy Testing

October 8, 2020

Tony Hagen

Article

Simplified standards for biosimilar approvals in the United Kingdom may open the door to broader changes.

FDA Reshuffles Priorities to Meet COVID-19 Trial Demand

October 7, 2020

Tony Hagen

Article

The FDA has had to rely on triaging to address its most critical priorities during the unfolding coronavirus disease 2019 (COVID-19) pandemic, according to Peter P. Stein, MD.

IQVIA: Biosimilars Could Save $100 Billion Over Next 5 Years

October 6, 2020

Skylar Jeremias

Article

A report from the IQVIA Institute for Human Data Science states that assessments of the health of the US biosimilar market are too conservative.

EMA Begins Review of Samsung Bioepis' Ranibizumab

October 6, 2020

Tony Hagen

Article

The European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.

Review: FDA Should Reconsider Interchangeability Requirements

October 5, 2020

Tony Hagen

Article

Researchers contend the "totality of evidence" for biosimilar approval may be sufficient to demonstrate interchangeability.

Accord Launches 2 Biosimilars in the UK, Expands Partnership With Henlius

October 2, 2020

Skylar Jeremias

Article

Accord brought 2 biosimilars referencing blockbuster oncology products to the United Kingdom and amended its agreement with Shanghai Henlius Biotech.

Potential Cost Savings From Improving Biosimilar Availability in Slovakia

October 1, 2020

Deana Ferreri, PhD

Article

Biosimilars could improve health system sustainability in Slovakia; however, of the 54 biosimilars approved by the European Medicines Agency as of August 2019, fewer than half are available in Slovakia