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Lupin to expand US generics business with Gavis acquisition Pharma News | Posted 07/08/2015

Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 23 July 2015 that it had entered into a definitive agreement to acquire US generics makers Gavis Pharmaceuticals and Novel La...

Australia implements EMA’s biosimilars guidelines Guidelines | Posted 07/08/2015

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 3 June 2015 that it had adopted ten European Union (EU) guidelines in Australia.

Generic bivalirudin approved in US Generics/News | Posted 07/08/2015

US-based injectables and biosimilars specialist Hospira announced on 16 July 2015 the approval of its abbreviated new drug application (ANDA) for generic bivalirudin for injection by the US Food an...

EMA opens consultation on revision of biosimilar G-CSF guideline Guidelines | Posted 31/07/2015

On 27 July 2015, the European Medicines Agency (EMA) released a draft concept paper to discuss its planned revision of its specific guideline for biosimilars containing recombinant granulocyte colo...

Approval of biosimilar insulins: regulations across the globe Biosimilars/Research | Posted 31/07/2015

Insulin analogue patent expiry is likely to mean that biosimilars will be submitted for licensing. In light of this, Heinemann and co-authors reviewed regulatory requirements for biosimilars, notab...

Biosimilar infliximab offered to French hospitals at 45% discount Biosimilars/General | Posted 31/07/2015

A major French hospital group has chosen biosimilar infliximab to treat its patients with rheumatoid arthritis, Crohn’s disease and psoriasis, after major discounts on the drug were offered to the...

Effect of price caps and reference pricing on generics entry Generics/Research | Posted 31/07/2015

In a study carried out by Brekke and co-authors on the impact of price caps in combination with reference pricing on generics entry was investigated [1].

ACR position statement on biosimilars addresses naming and substitution Biosimilars/General | Posted 31/07/2015

The American College of Rheumatology (ACR) has issued a position statement on biosimilars, reflecting its views on issues such as interchangeability, substitution, naming and post-marketing surveil...