More Articles

Generics reform in Korea Guidelines | Posted 31/07/2020

The Korean Ministry of Food and Drug Safety (MFDS) has taken action to improve the quality of generic drug products and ensure an efficient and competitive generics market.

Trastuzumab biosimilar Kanjinti is stable over extended storage periods Biosimilars/Research | Posted 24/07/2020

An investigation of the quality and in-use stability of diluted trastuzumab biosimilar Kanjinti (also known as ABP 980) versus the reference trastuzumab demonstrated no clinically meaningful differ...

Low levels of biosimilar uptake in Canada Reports | Posted 24/07/2020

Data from Canada’s Patented Medicine Prices Review Board (PMRPB) reveal an increasing number of biosimilar approvals in recent years, yet Canada lags behind other nations in terms of both approvals...

EMA approves bevacizumab and teriparatide biosimilars Biosimilars/News | Posted 24/07/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 June 2020 that it had recommended granting marketing authorization for the bevacizumab bi...

China publishes new patent law amendment Policies & Legislation | Posted 24/07/2020

On 3 July 2020, China’s Standing Committee of the National People's Congress published a second draft amendment to its Patent Law. This introduces patent linkage, patent term extension and patent t...

FDA approves pegfilgrastim biosimilar Nyvepria Biosimilars/News | Posted 24/07/2020

Pharma giant Pfizer announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Nyvepria (HSP-130).

Biosimilar pipelines for Korean firms looking healthy Biosimilars/General | Posted 24/07/2020

Korean companies are becoming more and important both in the country but also worldwide when it comes to developing biosimilars.

Perrigo sells its UK generic drug business Pharma News | Posted 24/07/2020

Perrigo Co Plc (Perrigo) has sold its generic prescription drug business to a private equity firm in a deal worth US$195 million.