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FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars Biosimilars/News | Posted 20/04/2018

South Korean biotechnology company Celltrion announced on 6 April 2018 that it had received complete response letters (CRLs) from the US Food and Drug Administration (FDA) regarding its candidate r...

Interchangeability for biosimilars Reports | Posted 20/04/2018

Dr Daniel F Alvarez, Senior Director at Pfizer, gave a presentation on interchangeability for biosimilars at the Drug Information Association’s (DIA) Biosimilars Conference, which was held on 24−25...

Switchback rates between generic and brand-name drugs Generics/Research | Posted 20/04/2018

A study carried out by researchers from Harvard Medical School found a lower rate of switchback when patients were switched to an authorized generic from the brand-name product rather than when the...

Afucosylated biosimilars: the path to matching interrelated critical quality attributes Biosimilars/Research | Posted 20/04/2018

Advances in analytical characterization and increased understanding of drug mechanisms of action have resulted in the ability to raise the quality and safety of biosimilars by introducing critical...

CFDA to come under national market supervision administration Policies & Legislation | Posted 20/04/2018

A sweeping government restructuring plan was approved by China’s National People’s Congress on 17 March 2018. The reorganization will see China’s drug regulator, the China Food and Drug Administrat...

Naming is an obstacle to the use of biosimilars in the US Biosimilars/Research | Posted 20/04/2018

Factors that may account for the slow development of the market for biosimilars in the US are discussed by Professor Richard Frank from the Department of Health Care Policy, Harvard Medical School,...

Generics companies defend against illegal ‘pay-for-delay’ charges Generics/General | Posted 20/04/2018

In March 2018, pharmaceutical companies in the US and Europe have had to defend themselves against antitrust charges. Illegal ‘pay-for-delay’ deals enable companies to profit by delaying the releas...

Obstacles to the use of biosimilars in the US Biosimilars/Research | Posted 13/04/2018

Professor Richard G Frank from the Department of Health Care Policy, Harvard Medical School, Boston, USA, discusses factors that may account for the slow development of competition in the market fo...