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Positive EMA-CHMP opinion for SC infliximab biosimilar Biosimilars/News | Posted 27/09/2019

South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for appr...

Mylan’s insulin biosimilar blocked, but wins patent battle over pegfilgrastim biosimilar Biosimilars/General | Posted 27/09/2019

Mylan has received a second complete response letter (CRL) from the US Food and Drug Administration (FDA) over its Lantus biosimilar, while a US District Court rules in their favour over their pegf...

Shanghai Pharma and Russia’s Biocad form joint venture to sell cancer and autoimmune drugs in China Pharma News | Posted 27/09/2019

Shanghai Pharmaceuticals Holding and Russia’s Biocad Pharmaceutical have agreed to form a joint venture to develop, manufacture and market cancer and autoimmune disease treatments in China.

Samsung Bioepis to supply Brenzys to Brazil under production development partnership Biosimilars/News | Posted 27/09/2019

On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to...

Switching from originator infliximab to CT-P13: real-world data with 24 months of follow up Biosimilars/Research | Posted 27/09/2019

A prospective observational study with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC) patients switched from infliximab to CT-P13 treatment was carried out at Hospital Universi...

Evaluating success: generics substitution policy in Chile Generics/Research | Posted 27/09/2019

The effectiveness of Chile’s 2014 generics substitution policy has been assessed by an international team of researchers. In their BMJ Global Health [1] article, the authors reveal that, although t...

EMA approves leukaemia and multiple myeloma generics Generics/News | Posted 27/09/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 20 September 2019 that it had recommended granting marketing authorization for hypertension...

A call to end US drug pricing games Policies & Legislation | Posted 27/09/2019

In a modern world dominated by personal choice, we still lack choice when it comes to health care. In the US, pharmaceutical companies play a drug pricing game that prevents low-cost medicines from...