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Lupin’s generic diabetes drug approved and asthma drug launched in US Generics/News | Posted 04/09/2020

In August 2020, India-based generics maker Lupin announced that it has received approval from the US health regulator to market a generic diabetes drug in America. Following previous US Food and Dr...

The biosimilars market in Latin America: a summary Biosimilars/Research | Posted 28/08/2020

A review of the biosimilars market in Latin America [1] finds that Argentina, Brazil and Mexico have the largest number of approved similar biotherapeutic products (SBPs), while information in othe...

EMA recommends approval of bevacizumab biosimilar Equidacent Biosimilars/News | Posted 28/08/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 July 2020 that it had recommended granting of marketing authorization for the bevacizumab...

Cost savings from biosimilars in Canada: actual and projected Reports | Posted 28/08/2020

Information from the Patented Medicine Prices Review Board (PMPRB) in Canada details the cost savings that could be made from biosimilars in the country.

Teva changes course in Japan and the US Pharma News | Posted 28/08/2020

Israeli drugs manufacturer Teva has made strategic decisions in the US and Japan. The company plans to strip back its Japanese venture with Takeda, selling off parts of the portfolio by early 2021....

Alexion delays Soliris biosimilar until 2025 Policies & Legislation | Posted 28/08/2020

Alexion Pharmaceuticals has reached a patent settlement with Amgen over Soliris (eculizumab), Alexion’s blockbuster antibody treatment for the blood disease paroxysmal nocturnal haemoglobinuria (PN...

Generics substitution in Finland: a pharmacy dispenser perspective Generics/Research | Posted 28/08/2020

In Finland, mandatory generic drug substitution was adopted in 2003 [1]. This is overseen by pharmaceutical staff who give advice to patients and decide which drug products they should receive. A r...

Clinical trials for trastuzumab biosimilars Biosimilars/General | Posted 28/08/2020

Roche’s originator trastuzumab biological (Herceptin) was approved by the US Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000 [1]. The...