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Do patent strategies delay market entry of biosimilar monoclonal antibodies in Europe? Biosimilars/Research | Posted 22/05/2020

Patents have been shown to be the main determinant to guarantee market exclusivity of originator biologicals [1], with patent disputes causing uncertainty on a patent’s validity and subsequently po...

Canada approves rituximab biosimilars Riximyo and Ruxience Biosimilars/News | Posted 22/05/2020

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilars Riximyo (GP2013) and Ruxience (PF-05280586) for the treatment of rheumatoid arthritis as well as chronic lymphocytic l...

Reimbursement of biosimilars in the US Biosimilars/General | Posted 22/05/2020

Barriers to market uptake of biosimilars in the US include biosimilars pricing, legal and promotional wars being waged by originator companies, and the lack of confidence in biosimilars [1, 2].

China publishes draft guideline for denosumab copy biologicals Guidelines | Posted 22/05/2020

Another specific guidance for makers of copy biologicals has been published by China’s Center for Drug Evaluation (CDE). This time the guidance covers denosumab.

Canadian firm Bausch + Lomb signs agreement on Lucentis biosimilar Pharma News | Posted 22/05/2020

Canadian eye health specialists Bausch + Lomb have signed an exclusive licensing agreement with Stada and its development partner Xbrane to develop and commercialize a Lucentis biosimilar in Canada...

Amgen on both sides of the biosimilar arena Biosimilars/General | Posted 22/05/2020

Amgen has both originator biologicals and also biosimilars in its portfolio, which means the US-based drugmaker can be on both sides of the fence when it comes to biosimilars.

Impact of upcoming regulatory changes on patent disputes in Australia Policies & Legislation | Posted 22/05/2020

Following a series of proposed transparency reforms from the Australian Therapeutic Goods Administration (TGA), a recent commentary explains what the changes will mean for pharmaceutical patent dis...

COVID-19 drugs: Gilead’s remdesivir and Algernon’s alternative Generics/News | Posted 22/05/2020

Gilead Sciences has signed licensing agreements with five generics manufacturers based in India and Pakistan to increase production of its experimental COVID-19 drug remdesivir.