Istanbul, Turkey, March 9th, 2018 – TRPharm announced today the upcoming launch of their lead biosimilar brand, Rituximab Biosimilar, indicated for the treatment of Non-Hodgkin’s Lymphoma (NHL) and Chronic Lymphocytic Lymphoma (CLL). This follows the marketing authorization that was obtained on January 30th, 2018. The product was developed by Dr. Reddy’s Laboratories and first approved by Indian health authorities on March 22, 2007. It is currently used by physicians and patients in more than 17 countries.
In 2016, TRPharm and Dr. Reddy’s announced the strategic collaboration agreement in Turkey. Under the terms of this agreement, TRPharm will register and commercialize a total of three biosimilar products from Dr. Reddy’s in Turkey. TRPharm will also manufacture the drug substance and drug product upon completion of its facility investment.
“The approval of Rituximab Biosimilar in Turkey represents a historic milestone for TRPharm. We firmly believe that with continued collaboration with the authorities, we will also turn this product to be the first mAb drug substance to be produced in Turkey.” said Mehmet Göker, Chairman and Chief Executive Officer of TRPharm. He added, “At TRPharm, we understand the value of biosimilars in not only enabling access to these important therapies for more patients but also lowering healthcare costs in one area to pave the way for newer and innovative treatments in others. We pride ourselves on being a solution partner to patients, physicians, and governments in both areas with our differentiated and diverse portfolio of biosimilars and novel therapies. We look forward to our continued expansion of this vision beyond Turkey and into the rest of the MENA region.”
That the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components; and,
There are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
TRPharm is a biopharmaceutical company focused on innovation through investments in R&D and a cutting edge biotechnological manufacturing facility, with the aim of becoming a regional commercial player based out of Turkey. TRPharm focuses on the launch of new and innovative medicines, from registration and successful completion of clinical programs through to commercialization, as well as building a biotech manufacturing facility in Turkey for the supply of monoclonal antibodies to CIS and MENA region. TRPharm has a broad product portfolio, led by oncology, neurology, inflammatory and rare diseases.
About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com
Ozan Efe Ertem, Business Development and Strategy Sr. Manager, firstname.lastname@example.org
- Christl L. FDA’s Overview of the Regulatory Guidance for the Development and Approval of Biosimilar Products in the US. 2014.
http://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/therapeuticbiologicapplications/biosimilars/ucm428732.pdf. Accessed January 15, 2018.