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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 ...

Celltrion submits its application for CT-P17 (adalimumab) to the EMA. If approved, CT-P17 will be the first high-concentration adalimumab available.

On 09 March 2020, 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 the damage caused by false and misleading statements a...

The US Federal Court of Appeals for the Circuit Court affirms the lower court’s refusal to preliminary injunct Amgen for its sale of biosimilar trastuzumab. Trial is expected to begin on 20 April, 2020.

Shanghai Henlius Biotech announces China’s National Medical Administration had accepted its Investigational New Drug application for HLX14 (denosumab). HLX14 is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

Significant biosimilar activities this week include
02 Mar 20 | Celltrion launched Remsima SC, its subcutaneous infliximab product, in the UK. To support the launch, Celltrion held a symposium at which it showcased the product and supporting data. Celltrion has signed...

On 06 March 2020, in its 2019 Q4 earnings call, Mylan announced the FDA has accepted its aBLA for a proposed bevacizumab biosimilar. The FDA’s decision is expected on or before December 27, 2020.

In its 2019 Q4 earnings call, Mylan announces the FDA has accepted its aBLA for a proposed bevacizumab biosimilar. The FDA’s decision is expected on or before December 27, 2020.