KRABEVA will be an important addition to our oncology portfolio of novel biologics as well as biosimilars

Biocon has recently launched a biosimilar in the Indian market. Suresh Subramanian, Sr Vice President & Head Branded Formulations, Biocon, gives more details about the product and their plans for it, in an interaction with Express Pharma

You have launched a new biosimilar called KRABEVA in India. Tell us more about it.

Biocon’s KRABEVA is 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 the second key oncologic biosimilar product from Biocon’s global biosimilars portfolio to be launched in India. 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 and help address the unmet patient needs for affordable biological therapies. 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 being launched in India post successful completion of Phase III clinical trials and approval of Biocon’s Marketing Authorization Application by the Drug Controller General India, DCG(I).

What is the market opportunity for this biosimilar as there are multiple players already with biosimilar version of Bevacizumab?

The size of the market for Bevacizumab in India is estimated to be ` 177 crores, with a growth of 15 per cent YoY, according to IMS June MAT Data. In fact, the entry of biosimilar versions of Bevacizumab last year have expanded the market for the drug. Bevacizumab sales volume has risen over 1.5 times since 2015, from nearly 50,000 units to over 83,000 in 2017. Interestingly, over 45 per cent of this volume can be attributed to biosimilars. Within a year, the sales volume of biosimilar versions has grown almost 16 times. This indicates the growing acceptance of biosimilar versions of Bevacizumab.

What differentiates KRABEVA from among others brands of biosimilar Bevacizumab?

KRABEVA 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 up to infusion. KRABEVA’s innovative temperature-sensitive packaging includes thermo-chromic stickers, which change colour irreversibly if the cold chain temperature is not maintained. Most biologic products require a specific storage condition to maintain safety, purity and potency of the drug. An efficient and seamless cold chain prevents denaturation of antibodies due to heat. This first-of-its-kind ‘Qual Check’ feature ensures quality check of the product up to the point of administration to the patient. This will provide greater confidence to pharmacists, nurses and caregivers about the quality of the product they are dispensing and will enable better patient safety.

Biocon is known for high quality at an affordable price. What will be the price for KRABEVA?

Biocon has priced the product at an MRP of Rs 24,000 for 100 mg/4 mL vial and Rs 39,990 for 400 mg/16 mL vial. This is substantially lower than the MRP of the 400 mg presentation of the innovator products currently available and lower than some of the other biosimilar versions in the market.

Tell us about the clinical development programme for Bevacizumab.

KRABEVA was launched in India after a successful Phase III clinical trial on metastatic colorectal cancer (mCRC) patients in India. The study found KRABEVA to be equivalent in terms of safety, efficacy and immunogenicity to the reference biologic. A three-way Phase I PK study in healthy volunteers was also conducted in Europe. Currently, a global Phase III trial in Non-Small Cell Lung Cancer (NSCLC) patients is being conducted at more than 100 sites across multiple countries.

How much time did it take you to bring bevacizumab to market from the start?

It usually takes six to eight years to develop a biosimilar molecule. Biocon’s biosimilar bevacizumab candidate has been developed with a clear focus to meet strict quality and regulatory requirements and increase patient access in India and globally, including the US and EU.

From your experience in various international markets, how much time does it take for a biosimilar approval process in India?

The approval process in India upon submission of the complete data package can take up to six months, approval in certain ROW countries could take up to two years, while in developed markets like the US and EU it ranges between 10-15 months.