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Australian prescribers’ views on biologicals naming and substitution Biosimilars/Research | Posted 03/11/2017

In a survey of 160 prescribers of biologicals in Australia, over three quarters agreed that the country’s Therapeutic Goods Administration (TGA) should insist on distinct non-proprietary scientific...

EMA accepts biosimilar pegfilgrastim application from Sandoz Biosimilars/News | Posted 03/11/2017

Sandoz, the generics division of Novartis, announced on 27 October 2017 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medici...

Biosimilar insulins – reducing the cost of diabetes Biosimilars/Research | Posted 03/11/2017

Will biosimilar insulins be cheaper is a question raised by authors Lutz Heinemann and Alan Carter and one that they say is a clear yes [1].

New use for old generic could treat rare cardiovascular condition Generics/Research | Posted 03/11/2017

Researchers from Canada and the UK may have found a new use for an old generic drug: treatment of the rare cardiovascular condition, pulmonary arterial hypertension (PAH).

Hospira to pay Amgen US$70 million for epoetin alfa patent infringement Biosimilars/General | Posted 03/11/2017

US-based injectables specialist Hospira has been ordered to pay Biotech giant Amgen US$70 million in damages regarding a patent on Amgen’s anaemia blockbuster Epogen (epoetin alfa).

Amneal and Impax combine to create 5th largest US generics company Pharma News | Posted 03/11/2017

US generics makers Amneal Pharmaceuticals (Amneal) and Impax Laboratories (Impax) announced on 17 October 2017 that they had entered into a definitive deal to combine the two companies.

FDA releases 52 new and revised bioequivalence guidelines for generics Guidelines | Posted 03/11/2017

As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents...

Texan judge invalidates Restasis patents Generics/General | Posted 03/11/2017

On 16 October 2017, a federal judge in Texas invalidated four key patents for Allergen’s dry eye drug Restasis (cyclosporine ophthalmic emulsion).