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FDA issues final guidance on interchangeable biologicals Guidelines | Posted 17/05/2019

The US Food and Drug Administration (FDA) announced on 10 May 2019 that it had issued final guidance on the pathway for interchangeable biologicals.

Biosimilars market and opportunities in Europe Reports | Posted 17/05/2019

How the biosimilars market in Europe has changed and what opportunities for biosimilars exist for the near term in the region is being reviewed by Murray Aitken in this article [1].

Canadian organizations collaborate to improve biosimilar adoption in cancer and inflammatory rheumatic and bowel disease Biosimilars/General | Posted 17/05/2019

With a number of biosimilars expected to launch in Canada in 2019 and beyond, Canadian organizations are collaborating to improve biosimilar adoption. Canada lags behind the European Union in terms...

Multi-state lawsuit alleges widespread generic price fixing in the US Generics/General | Posted 17/05/2019

A sweeping lawsuit filed on 10 May 2019 by over 40 US states alleges that a number of major drug companies conspired to inflate the prices of generic drugs by as much as 1,000%.

Adalimumab biosimilar Idacio launched in Germany Biosimilars/News | Posted 17/05/2019

Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 3 May 2019 that it had launched its adalimumab biosimilar Idacio in Germany.

ASCO/ASH give recommendations for biosimilar ESAs Biosimilars/Research | Posted 17/05/2019

Recommendations for biosimilar erythropoiesis-stimulating agents (ESAs) in the management of cancer-associated anaemia have been issued by the American Society of Clinical Oncology (ASCO) and the A...

EMA approves hypertension and Parkinson’s generics Generics/News | Posted 17/05/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 April 2019 that it had recommended granting marketing authorization for hypertension and...

Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan Pharma News | Posted 17/05/2019

Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 9 April 2019 that they had made a binding agreement for the exclusive partnership and supply to commerciali...