Business

Amgen's Bourdon Discusses Riabni Rollout in the United States

December 23, 2020

Tony Hagen

Article

Christophe Bourdon, senior vice president and general manager of US Oncology for Amgen, discussed the development and marketing plan for the company's newly approved rituximab biosimilar.

AMCP Sets a Course for Biosimilar Promotion

December 22, 2020

Tony Hagen

Article

A partnership forum sponsored by the Academy of Managed Care Pharmacy (AMCP) yielded numerous ideas for improving access to biosimilars.

Bio-Thera Seeks to Enter Brazilian Market for Bevacizumab

December 20, 2020

Tony Hagen

Article

Building on regulatory submissions elsewhere, the company is looking to gain approval for bevacizumab candidate BAT1706 in Brazil.

Samsung Bioepis Examines European Awareness of Biosimilars

December 19, 2020

Tony Hagen

Article

In the EU-5 group of countries, biosimilar awareness is poor, hindering uptake of these potentially cost-saving medicines, a white paper states.

Sandoz Canada Gains Marketing Approval for Adalimumab Biosimilar

December 18, 2020

Tony Hagen

Article

The Canada Health approval for Hyrimoz will be followed by a launch in February 2021, Sandoz Canada said.

FDA Approves Rituximab Biosimilar "Riabni" From Amgen

December 17, 2020

Tony Hagen

Article

The approval of the Amgen product marks the third biosimilar approval in the United States since the beginning of 2020.

Policy Review Cites Need for Regulatory Clampdown on Pay-for-Delay Tactics

December 17, 2020

Deana Ferreri, PhD

Article

An international group of physicians, surgeons, lawyers, scientists, and pharmacists weighs in on biosimilar policy differences and deficiencies in the United States, Europe, and Japan.

Biocon/Mylan Receive CHMP Nod for Insulin Aspart Biosimilar in European Union

December 14, 2020

Tony Hagen

Article

The positive opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected to be followed by a European Commission final decision early in 2021.

Australian Biosimilar Trade Group Names New Chair

December 13, 2020

Tony Hagen

Article

Health care policy expert Jane Halton, AO, PSM, has been picked for her extensive experience in governmental health affairs.

Opinion: Boehringer Ingelheim May Win Regulatory Language Change Despite Weak Argument

December 12, 2020

Sarfaraz K. Niazi, PhD

Article

Boehringer Ingelheim's argument hinges on how "strength" of formulation is defined in regulatory language.

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