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Tony Hagen is senior managing editor for The Center for Biosimilars

Samsung Bioepis makes a move into the promising Brazilian market for biosimilars, which data suggest is one of the fastest-growing biosimilars markets among emerging nations.

Samsung Bioepis Enters Breast and Gastric Market in Brazil

Nancy J. Globus, PharmD, is Vice President of Regulatory Affairs for the Accreditation Council for Medical Affairs, based in Oradell, New Jersey. Nancy focuses on helping the industry build error prevention into products by evaluating proposed names and labels prior to regulatory approval. In her 20-year medication safety career, she has reviewed thousands of names for submission to FDA, European Medicines Agency, and Health Canada. In addition to medication safety, she is passionate about patient advocacy and community pharmacy. You can find her at www.medicalaffairsspecialist.org/approve or on Twitter @MedSafetyGal.

Alphabet Soup: The Story Behind Biosimilar Nonproprietary Name Suffixes

Biosimilars have improved access to health care in India, but many effective new drugs are high priced and patented, and authors of a new study recommend interventions to make these available, too.

ASCO Study: Mandatory Drug Licensing Can Bridge Care Divide

Despite there being concerns over the safety of nonmedical switching between a reference product and a biosimilar, there is a growing body of evidence supporting the safety of switching, according to an executive of Sandoz, which produces biosimilars.
 

Sandoz Executive Argues for Safety of Nonmedical Switching

Shanghai Henlius Biotech has been given the green light to market its trastuzumab biosimilar (Zercepac, HLX02) in the European Union. Accord Healthcare will handle the distribution.

Henlius Biotech Gets EC Marketing Approval for Zercepac

Although more advanced than in the United States, biosimilars markets in Europe may discourage competition over the long term, said officials from Medicines for Europe.

Interview: EU Biosimilars Markets Lack Competition

Additional indications for Remsima SC, an infliximab biosimilar, are approved by the European Commission (EC).

Celltrion's Subcutaneous Infliximab Gains EC Nod for 5 Indications

The Center for Biosimilars® (CfB) spoke with Adrian van den Hoven, director general of Medicines for Europe, and Diogo Piedade, market access manager for Medicines for Europe, about their scorecard report for biosimilar access in European markets.
 

Interview: Medicines for Europe Reports on EU Biosimilar Success

We sat down with Anurag Rathore, PhD, lead author of the study and coordinator of the Center of Excellence for Biopharmaceutical Technology in Delhi, India, to discuss the findings from this study and how biosimilar corporations can learn from them.

Regulatory