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Apotex having trouble with Competitive Generic Therapy exclusivity Generics/News | Posted 23/11/2018

In August 2018, the US Food and Drug Administration (FDA) approved its first drugs under the Competitive Generic Therapy (CGT) designation. The agency granted approval to several strengths of Canad...

Canadian report into international policies for biosimilars Reports | Posted 16/11/2018

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a report that investigates different international policies on the use of biosimilars [1].

Another adalimumab copy biological accepted for review in China Biosimilars/News | Posted 16/11/2018

The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another application for approval of an adalimumab copy biological, this time from...

Biosimilars makers in South Korea to benefit from new accounting guideline Guidelines | Posted 16/11/2018

South Korea’s financial authority has released new ‘relaxed’ guidelines for how drugmakers should list research and development ‘R & D’ spending as assets in an attempt to resolve the controver...

Higher generics use results in higher Medicare Part D star ratings Generics/Research | Posted 16/11/2018

A study conducted by researchers from Auburn University and IMPAQ International has found that Medicare# Part D* prescription plans with higher generics use have higher summary star ratings and imp...

Amgen collaborates with Orion to market Amgevita in Finland Pharma News | Posted 16/11/2018

The Orion Group announced on 24 October 2018 that it will distribute Amgen’s adalimumab biosimilar in Finland.

Generics companies winning the legal battle in the US Generics/News | Posted 16/11/2018

Litigation in the US is clearing the way for generics competitors to enter the market. The latest cases include Spring Pharmaceuticals suing Retrophin for blocking generics of kidney stone drug Thi...

Appeal by Australia’s watchdog against Pfizer ruling dismissed Policies & Legislation | Posted 16/11/2018

Australia’s High Court has rejected the nation’s competition watchdog’s efforts to revive an antitrust case accusing Pfizer of abusing its market power to maintain control of the Australian generic...