Biocon has launched Krabeva, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India.
This is a monoclonal antibody (mAb) developed by Biocon, will help expand access to a world class, high quality biosimilar Bevacizumab for cancer patients in India. It is the world’s first and only Bevacizumab with a unique ‘Qual-Check’ mechanism, which will ensure that patients get a quality-ascertained product right upto infusion.
Dr Arun Chandavarkar, chief executive officer & joint managing director, Biocon said: “With Krabeva we intend to provide a high quality, world-class biosimilar Bevacizumab as an affordable therapy option for patients of various types of cancer. We believe Krabeva will be an important addition to our Oncology portfolio of novel biologics as well as biosimilars, which are making a significant impact in the realm of cancer care in India.”
Krabeva is the second key oncologic biosimilar product from Biocon’s global biosimilars portfolio to be launched in India, in order to address the unmet patient need for affordable biological therapies. It is being offered to patients at an MRP of Rs. 24,000 for 100 mg / 4 ml vials and Rs. 39,990 for 400 mg / 16 ml vials, making it a high quality affordable alternative to the innovator brand.
KRABEVA is being launched post successful completion of Phase III clinical trials and approval of Biocon’s Marketing Authorization Application by the Drug Controller General of India (DCGI).
Most biologic products require a specific storage condition to maintain the safety, purity and potency of the drug. An efficient and seamless cold chain prevents denaturation of antibodies due to heat. Krabeva is being introduced with an innovative temperature-sensitive packaging that includes thermo-chromic stickers, which change colour irreversibly if the cold chain temperature is not maintained.
The phase III clinical study involving 146 patients of mCRC, has been conducted after obtaining regulatory approvals in India.
The global Phase III trial in non-small-cell lung cancer (NSLC) patients is being conducted at more than 100 sites across multiple countries using an EU and US sourced reference product. Prior to this, a three-way Phase I PK study in healthy volunteers was conducted in Europe.
There were an estimated 1.14 lakh new lung cancer cases in India in 2016 and the number is projected to grow to 1.40 lakh by 2020, according to ICMR. Similarly, new cervical cancer cases are expected to rise from an estimated 1 lakh in 2016 to about 1.04 lakh by 2020.
Global sales of the innovator product in 2016 were pegged at USD 6.9 billion. The market size for Bevacizumab, both innovator product and biosimilars, in India is estimated at Rs. 177 Crore (US$ 27 million), according to IPSOS June MAT 2017 data.
Source : www.pharmabizz.com
Published on: November 29, 2017