Tocilizumab (Actemra/RoActemra) Biosimilar Antibody Pipeline Review
Tocilizumab (Actemra/RoActemra) Biosimilar Antibody Pipeline Review
Reference Product: Actemra / RoActerma
Target: Interleukin-6 receptor (IL-6R)
Product Category: Antibody
This product provides basic information on drugs on the market and drug candidates in research and development as biosimilar antibodies of Actemra/RoActemra (tocilizumab).
This product consists of:
- Competitors described in a tabular format covering drug code/INN, target(s)/MoA, class of compound, territory of main competitor, indication(s) & R&D stage.
- Project History with link to source of information (press release, homepage, abstracts, presentations, annual reports etc).
- One-month online access to La Merie Publishing’s database for tocilizumab (Actemra/RoActemra) biosimilars (prerequisite: access to internet).
This product is delivered on the very same day by e-mail containing competitor and project history reports in pdf format and database credentials. Reports are prepared on the same day.
Developed by Roche and Chugai Pharmacutical Co, the blockbuster therapeutic antibody Acterma (US) / RoActemra (EU) (tocilizumab) was first approved by the EMA in 2009 and by the US FDA in 2010 to treat patients with rheumatoid arthritis (RA). Since the, Actemra/RoActerma has been approved for treatment of Giant Cell Arteritis (GCA), Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), Polyarticular Juvenile Idiopathic Arthritis (PJIA), Systemic Juvenile Idiopathic Arthritis (SJIA), Cytokine Release Syndrome (CRS), and Coronavirus Disease 2019 (COVID-19
Roche disclosed that basic, primary patents for Actemra/RoActemra have expired in the U.S. and EU. In 2023, Actemra/RoActemra posted global sales of US$ 3 bln.
Biosimilars are follow-on versions of biopharmaceuticals, for which exclusivity has expired. They are approved via stringent regulatory pathways in highly regulated markets (such as EU, US, Japan, Canada, Australia) based on proven similarity of the biosimilar with the originator biopharmaceutical reference product.