The Center for Biosimilars Staff

Dive into biosimilar regulations in the US! Test your knowledge with our quiz on FDA rules, naming tricks, postmarket safety, and more. Ready for the challenge?

Have you been keeping up with the latest market trends? Take this quiz to find out how well you know the global biosimilars market.

Explore the dynamic world of global biosimilar markets and policies! What do you know about the international biosimilar industry?

Test your knowledge of major biosimilar policies, including challenging regulatory frameworks from around the world.

Intro to Biosimilars is now in session! Test yourself on how well you know these biosimilar basics.

Here are the top 5 biosimilar articles for the week of November 6, 2023.

Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could have an impact on future cases.

As part of a series of interviews, Kyung-Ah Kim, executive vice president of Samsung Bioepis, offered insight into how developers view the current biosimilars market, the relevance of interchangeability, and the usefulness of clinical efficacy testing.

In an interview with The Center for Biosimilars®, Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, breaks down the benefits of biobetters, how they differ from biosimilars, and how they could alter the future landscape of the biologics industry.

In the third quarter, ending December 31, 2021, biosimilars revenues were up 28% year over year for Biocon Biologics Ltd.

This is the third Form 483 Biocon has received for the insulin plant in 3 years.

Ultimately, the Purple Book is supposed to include all Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) regulated products, including transition biological products.

With Trazimera in place, Herceptin now has 3 biosimilar competitiors.

Drug maker Coherus announced today that it has received a positive opinion on its pegfilgrastim biosimilar, CHS-1701, from the European Medicines Agency’s Committee for Human Use (CHMP). Coherus plans to sell the drug under the name Udenyca. Separately, Accord Healthcare received a positive opinion for its own pegfilgrastim biosimilar, which it plans to market as Pelgraz.

A recent survey of US rheumatologists found that there is room for improvement in clinicians' awareness of biosimilar therapies.