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Samsung Bioepis announces the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).

Significant biosimilar activities this week include
16 Mar 20 | Teva and Celltrion launched Herzuma (trastuzumab) in the US. Herzuma is indicated for the treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer.
19 Mar 20 | The Centre f...

On 20 March 2020, Biocon announced it had received an Establishment Inspection Report from the FDA, clearing its manufacturing facility in Bengaluru.

On 19 March 2020, the Centre for Biosimilars reported on a pair of biosimilar bills which were introduced to the US Congress in the 2 weeks prior. These bills include a ‘shared savings’ model designed to encourage physicians to switch patients to biosimilars, an...

A new study reports that Truxima®  is comparable to the originator in terms of efficacy and safety in the treatment of multiple sclerosis.

Teva and Celltrion launch Herzuma® (trastuzumab) in the US. Herzuma® is indicated for the treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer.

Significant biosimilar activities this week include
09 Mar 20 | The FDA and FTC held a public workshop to further their efforts in creating a better biosimilar landscape in the US. The Centre for Biosimilars reported that topics discussed at the conference included th...

J&J announces Dano® is now also indicated for the treatment of adults with moderate to severe Crohn’s Disease. 

Hisun Pharmaceuticals completes Phase III trials of HS016 (adalimumab). Researchers concluded that HS016 was similar to adalimumab in terms efficacy and safety in the treatment of ankylosing spondylitis.

On 10 March 2020, Theradiag announced CE marking for its first four i-Tracker® test kits. The Infliximab, i-Tracker® Anti-Infliximab, i-Tracker® Adalimumab and i-Tracker® Anti-Adalimumab are designed to improve individual therapeutic drug monitoring and to allow clinicians ...