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17 Jul 2019

Case Study : Rituxan – A Brand which Pharma Industry reckon

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Brand Name: Rituxan
Company: 
Roche
2017 U.S. sales: $4.41 billion
Disease: Blood cancers, rheumatoid arthritis

Dosage form: Injection for Intravenous Use

Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, Wegener’s granulomatosus, microscopic polyangiitis, and pemphigus vulgaris.

In – Rituxan is one of the top leading brand by revenue with 6.8 Billion sales.

Learn more about Rituxan development timeline >> Learn more

Top 6 leading pharma brand globally by revenue in 2018

Timeline of Development of Rituxan

Rituxan Development Timeline

Some Facts:

  • Rituximab was developed by researcher Nabil Hanna and coworkers at IDEC Pharmaceuticals under the name IDEC-C2B8.
  • The U.S. patent for the drug was issued in 1998 and expired in 2015.
  • Based on its safety and effectiveness in clinical trials, rituximab was approved by the U.S. Food and Drug Administration in 1997 to treat B-cell non-Hodgkin lymphomas resistant to other chemotherapy regimens.
  • Rituximab, in combination with CHOP chemotherapy, is superior to CHOP alone in the treatment of diffuse large B-cell lymphoma and many other B-cell lymphomas.
  • In 2010 it was approved by the European Commission for maintenance treatment after initial treatment of follicular lymphoma.
  • Rituximab is currently co-marketed by Biogen and Genentech in the U.S., by Hoffmann–La Roche in Canada and the European Union, Chugai Pharmaceuticals, Zenyaku Kogyo in Japan and AryoGen in Iran.
  • It is on the World Health Organization’s List of Essential Medicines, a list of the most important medications needed in a basic health system.
  • In 2014 Genentech reclassified rituxan as a specialty drug, a class of drugs that are only available through specialty distributors in the US. Because wholesalers discounts and rebates no longer apply, hospitals would pay more.
  • Originally available for intravenous injection (e.g. over 2.5 hrs), in 2016 it gained EU approval in a formulation for subcutaneous injection for CLL.
  • Patents on the drug in expired in Europe in February 2013 and in the US in September 2016.
    By November 2018, several biosimilars had been approved across India, the European Union, Switzerland, Japan and Australia.

USFDA approved Biosimilars

 

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