The market size for Bevacizumab, both innovator product and biosimilars, in India is estimated at Rs 177 Crore (USD 27 million), according to IPSOS June MAT 2017 data.
Moneycontrol News
Biocon on Thursday said it has launched Bevacizumab, a biosimilar version of Swiss pharmaceutical major Roche's anti-tumour drug Avastin in India.
Biocon will be selling its version of Bevacizumab under brand name Krabeva at an aggressive pricing of Rs 24,000 for 100 mg / 4 ml vials and Rs 39,990 for 400 mg / 16 ml vials.
Biocon will be competing against other drug makers such as Intas, Hetero Labs, Reliance Life Sciences and Zydus Cadila for market share in India for the cancer drug.
In an email interview to Moneycontrol Suresh Subramanian, Senior Vice President and Head of Branded Formulations at Biocon spoke about what this approval means to Biocon and company's plans to expand its branded formulation business.
Can you explain how your biosimilar version of Bevacizumab helps cancer patients?
Krabeva introduced by Biocon in India is a biosimilar monoclonal antibody, indicated as a first-line treatment of patients with metastatic colorectal cancer (mCRC), and is accepted as a standard treatment option in combination with chemotherapy for patients with non-small-cell lung cancer (NSLC), metastatic renal cell carcinoma and recurrent ovarian cancer.
This is the second key oncologic biosimilar product from Biocon’s global biosimilars portfolio aimed at providing affordable cancer care alternative to address unmet patient needs. 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 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).
What is the R&D cost including that of clinical trials done on developing Bevacizumab?
We cannot share molecule-wise specific expense details but would like to share that the cost of developing any biosimilar for global markets is estimated to be around USD 75-150 million in comparison to USD 2-5 million required to develop a generic. This is because biosimilars are large and complex target-specific molecules, placed at the high end of the pharma value chain.
In addition, the investment required for setting up a biologics manufacturing facility ranges from tens to hundreds of millions of dollars. For example, it would take USD200-500 million to build a large-scale biologics manufacturing facility versus USD30-100 million to build a small molecule manufacturing facility.
What is this ‘Qual Check’ feature of Krabeva?
Krabeva , a monoclonal antibody (mAb) developed by Biocon, is 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 is being introduced with an innovative temperature-sensitive packaging that includes thermo-chromic stickers, which changes colour irreversibly if the cold chain temperature is not maintained.
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. The new feature is important because 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.
What kind of revenue do you expect from Krabeva ?
While we can’t provide a guidance on expected Krabeva sales, suffice it to say that Krabeva will be an important addition to our oncology portfolio of biologics including biosimilars and novels, which are making a significant impact in the realm of cancer care in India.
Bevacizumab, as you know can be prescribed for the treatment of patients with metastatic colorectal cancer and several other types of lung, kidney, cervical, ovarian and brain cancers, in India. We hope to provide a large number of cancer patients our high quality, affordable Krabeva.
An estimated 64,000 cases of colorectal cancer were diagnosed and 49,000 deaths recorded due to the disease in India, according to GLOBOCAN’s 2012 estimates of the worldwide incidence and mortality from cancers.
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.
The market size for Bevacizumab, both innovator product and biosimilars, in India is estimated at Rs 177 crore (USD 27 million), according to IPSOS June MAT 2017 data.
What kind of a boost do you expect KRABEVA sales to give to your branded formulations India business?
The branded formulations business in Q2FY18 had reported a YoY revenue growth of 29 percent at Rs 176 crore. Good traction in major verticals such as metabolics, oncology, comprehensive care and the institutional business drove the robust performance last quarter.
As Krabeva is being launched in mid-Q3, we expect our oncology portfolio to benefit from it even though the full revenue impact from Krabeva launch will fully reflect only in Q4.
You have said Krabeva be an important addition to your oncology portfolio in India. How are your other brands performing?
As one of the leading oncology companies in India, we are committed to bring safe, efficacious and affordable medicines for cancer to cater to the needs of patients, caregivers and medical practitioners in the country.
Thousands of cancer patients have so far benefited from our oncology portfolio, which is a mix of innovator, biosimilar and generic products. BIOMAb EGFR, CANMAb, EVERTOR, Fosaport, Genxtor from our Oncotherapeutics portfolio featured among the top 3 brands in their respective categories in Q2FY18.
CANMAb, our biosimilar Trastuzumab brand, has helped treat several thousand HER2-positive metastatic breast cancer patients in India since its launch in 2014. It ranks as the No. 2 brand (Source: IMS) of Trastuzumab in the country, and garnered a volume market share of over 30 percent in Q2FY18.
BIOMAb EGFR, an affordable, novel MAb therapy targeted at head and neck cancer is considered the best available treatment in its class of drugs given its efficacy and superior safety profile in terms of minimal skin toxicity. The No. 1 brand in its category (Source: IMS), BIOMAb EGFR witnessed more than 1000 new enrolments in FY17.
