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Tony Hagen is senior managing editor for The Center for Biosimilars

Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.

Celltrion, Intract Pharma Strive for World's First Oral Infliximab

The buck stops with the FDA when it comes to approving coronavirus disease 2019 therapeutics applications, said Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA.

FDA Reassures on Biosimilar Progress as COVID-19 Applications Pile Up

Monoclonal antibodies may play a frontline role in dealing with COVID-19 infections, according to Anthony S. Fauci, MD.

Fauci Discusses Experimental COVID-19 Drugs and School Openings

There has been an outpouring of advocacy tugging biosimilars into the marketplace, and market share of these lower-cost drugs has increased.
 

Biosimilars Gain Market Share and Advocates Get Aboard

Up-and-coming Henlius Biotech consolidates its footing in the biosimilar world with another regulatory approval.

China Approves Henlius' Biosimilar Trastuzumab

Now that Polpharma Biologics has fully integrated Bioceros into its brand, the company hopes to become one of the world’s leading biologics manufacturers.

Polpharma Biologics: The Polish Biosimilar Powerhouse

United States Pharmacopeia (USP), the FDA, and others deliver constructive critique on how India can bolster quality in its biopharmaceutical industry.

USP Panel Recommends Quality Upgrade for India's Biopharmaceutical Industry

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

A new study showed that biosimilar interferon beta-1a (IFN-β-1a) may be effective in helping to treat patients with coronavirus disease 2019 (COVID-19).

CinnaGen Biosimilar Shows Promise in Treating COVID-19

Teva Pharmaceutical Industries has expanded on its hopes for a biosimilar comeback with a commercialization deal with Alvotech, which could bring as many as 5 biosimilars to the US market.

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