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Distinct suffixes will aid biosimilar competition, says new research Biosimilars/Research | Posted 09/08/2019

The differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake, finds a literature review recently published in GaBI Journal [1].

EMA accepts first application for Chinese-made biosimilar HLX02 Biosimilars/News | Posted 09/08/2019

China-based Shanghai Henlius Biotech (Henlius) announced on 21 June 2019 that the regulatory submission for its proposed trastuzumab biosimilar (HLX02) had been accepted by the European Medicines A...

Bill introduced in US to cut insulin prices Policies & Legislation | Posted 09/08/2019

Co-Chair of the Senate Diabetes Caucus, Senator Jeanne Shaheen, announced on 22 July 2019 the introduction of new legislation to combat rising insulin prices.

South Korea’s Celltrion to sell directly to Australia Biosimilars/General | Posted 09/08/2019

In a successful month for Celltrion, the company announces plans to directly sell its anticancer biosimilars in Australia and begins a clinical trial for allergy treatment CT-P39.

Rituximab copy biological accepted for review in China Biosimilars/News | Posted 09/08/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for approval of rituximab copy biological IBI301.

Real-world data on switching of etanercept biosimilars Biosimilars/Research | Posted 09/08/2019

Real-world and clinical data from different studies involving switching to etanerept biosimilars were presented at the European Congress of Rheumatology 2019 (EULAR 2019) [1].

Prestige and Pharmapark make deal for trastuzumab biosimilar Pharma News | Posted 09/08/2019

Singapore-based Prestige BioPharma (Prestige) and Russia-based Pharmapark announced on 8 July 2019 that they had signed an exclusive partnership and supply agreement for Prestige’s candidate trastu...

Certara technology achieves first FDA virtual bioequivalence approval for a complex generic drug Generics/News | Posted 09/08/2019

On 12 June 2019, Certara announced that its Simcyp physiologically-based pharmacokinetic (PBPK) modelling and simulation technology successfully demonstrated the bioequivalence of a complex generic...