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Mylan launches first trastuzumab biosimilar in Australia Biosimilars/News | Posted 23/08/2019

Global generics firm Mylan NV (Mylan) and collaborating Indian pharmaceuticals giant Biocon Ltd (Biocon) have announced the launch of the first trastuzumab biosimilar in Australia. The drug can be...

Samsung Bioepis starts phase III trial for eculizumab copy biological Biosimilars/News | Posted 23/08/2019

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is carrying out a phase III clinical trial for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

Australia approves three biosimilars in first half of 2019 Biosimilars/General | Posted 23/08/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has up until the end of June 2019 approved three biosimilars. The biosimilars approved in the country so far include two trastuzuma...

China audits drug companies Policies & Legislation | Posted 23/08/2019

In June and July 2019, China embarked on an audit of 77 major pharmaceutical companies, including the local arms of Sanofi, Eli Lilly & Co and Bristol-Myers Squibb Co. This action was undertake...

Agreement between Hikma and Civica to reduce US generic drug shortages Pharma News | Posted 23/08/2019

Hikma Pharmaceuticals Plc and Civica Rx announced a five-year agreement on 23 July 2019. Under the agreement, Hikma will manufacture and supply 14 essential sterile injectable medications for Civic...

Generic irbesartan is safe and effective, shows phase IV trial Generics/Research | Posted 23/08/2019

Generic versions of the anti-hypertensive irbesartan are equally effective as their branded counterparts, finds a phase IV study conducted in Korea. The study also found that irbesartan is less eff...

Safety of SC form of infliximab biosimilar CT-P13 Biosimilars/Research | Posted 23/08/2019

Positive results for Celltrion Healthcare’s (Celltrion) subcutaneous (SC) formulation of its infliximab biosimilar, CT-P13 (Remsima), have been presented at the European Congress of Rheumatology 20...

FDA approves Farxiga generic Generics/News | Posted 23/08/2019

The US Food and Drug Administration (FDA) has given tentative approval to Novartis for their generic version of AstraZeneca’s diabetes medicine Farxiga (dapagliflozin). Patent issues, however, must...