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Biocon Launches KRABEVA® in India, A Biosimilar Bevacizumab for Treating Several Types of Cancer
Biocon Launches KRABEVA® in India, A Biosimilar Bevacizumab for Treating Several Types of Cancer
On November 23, 2017, Biocon India’s premier Biopharmaceuticals Company announced that it 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 1.
KRABEVA®, 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 ´QualCheck ´ mechanism, which ensures that patients get a quality-ascertained product right up to infusion.
Bevacizumab is 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 or recurrent ovarian cancer.
KRABEVA® is the second key oncologic biosimilar product, from Biocon´s global biosimilars portfolio to be launched in India. 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. In comparison, the Innovator brand for Bevacizumab marketed as Avastin® by Roche India Private Limited costs over Rs 10, 7065 for 400mg / 16ml vial.
Bevacizumab is a monoclonal antibody (mAb) targeting Vascular Endothelial Growth Factor- A (VEGF-A), a cell protein that induces growth of blood vessels that feed tumors. By blocking this protein, Bevacizumab cuts the supply of food and oxygen to the tumor, thus starving it.
Bevacizumab is prescribed in the treatment of several cancers including metastatic colorectal cancer, ovarian cancer, advanced non-small-cell lung cancer, recurrent glioblastoma, cervical cancer and renal cancer. Bevacizumab was first approved by the United States Food and
Drug Administration (USFDA), in February 2004 2.
It also features in the World Health Organization’s (WHO) list of essential medicines 3. The WHO list of essential medicines contains the medications considered to be most effective and safe to meet the most important needs in a health system. The list is frequently used by countries to help develop their own local lists of essential medicine.
1 https://www.biocon.com/biocon_press_releases_231117.asp
2 https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125085
3 http://www.who.int/medicines/publications/essentialmedicines/EML_2015_FINAL_amended_NOV2015.pdf?ua=1
Approval and launch of a Bevacizumab biosimilar in India would provide an affordable therapy option for patients of various types of cancer.
//////////Biocon, KRABEVA®, India, Biosimilar, Bevacizumab, Cancer
FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer
August 14, 2014
The U.S. Food and Drug Administration today approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage (metastatic) cervical cancer.
Cervical cancer grows in the tissues of the lower part of the uterus known as the cervix. It commonly occurs when human papillomaviruses (HPV), a virus that spreads through sexual contact, cause cells to become cancerous. Although there are two licensed vaccines available to prevent many types of HPV that can cause cervical cancer, the National Cancer Institute estimates that 12,360 American women will be diagnosed with cervical cancer and 4,020 will die from the disease in 2014.
Avastin works by interfering with the blood vessels that fuel the development of cancerous cells. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin or in combination with paclitaxel and topotecan.
“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA’s priority review program, demonstrating the agency’s commitment to making promising therapies available to patients faster.”
The FDA reviewed Avastin for treatment of patients with cervical cancer under its priority review program because the drug demonstrated the potential to be a significant improvement in safety or effectiveness over available therapy in the treatment of a serious condition. Priority review provides an expedited review of a drug’s application.
The safety and effectiveness of Avastin for treatment of patients with cervical cancer was evaluated in a clinical study involving 452 participants with persistent, recurrent, or late-stage disease. Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.
The most common side effects associated with use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients.
Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.
| Country | Patent Number | Approved | Expires (estimated) |
|---|---|---|---|
| Canada | 2286330 | 2008-06-10 | 2018-04-03 |
| Canada | 2145985 | 2003-09-16 | 2012-10-28 |
| Property | Value | Source |
|---|---|---|
| melting point | 61 °C (FAB fragment), 71 °C (whole mAb) | Vermeer, A.W.P. & Norde, W., Biophys. J. 78:394-404 (2000) |
| Protein chemical formula | C6538H10034N1716O2033S44 |
|---|---|
| Protein average weight | 149 kDa |
A recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF). Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Bevacizumab is produced in a Chinese Hamster Ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin and has a molecular weight of approximately 149 kilodaltons.
sequence
>"Bevacizumab light chain" DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
>"Bevacizumab heavy chain" EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPEL LGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREE QYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPS REEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDK SRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized (from mouse) |
| Target | VEGF-A |
| Clinical data | |
| Trade names | Avastin |
| AHFS/Drugs.com | monograph |
| Licence data | EMA:Link, US FDA:link |
| Pregnancy cat. | C (US) |
| Legal status | ℞ Prescription only |
| Routes | Intravenous |
| Pharmacokinetic data | |
| Bioavailability | 100% (IV only) |
| Half-life | 20 days (range: 11–50 days) |
| Identifiers | |
| CAS number | 216974-75-3  |
| ATC code | L01XC07 |
| DrugBank | DB00112 |
| UNII | 2S9ZZM9Q9V |
| KEGG | D06409 |
| ChEMBL | CHEMBL1201583  |
| Chemical data | |
| Formula | C6638H10160N1720O2108S44 |
| Mol. mass | approx. 149 kDa |
Personalized Tumor Vaccine Hits Phase 2
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bevacizumab
str ref———-http://www.kidneycancerinstitute.com/Bevacizumab.html
Northwestern Medicine recently joined a landmark clinical trial to investigate if a vaccine made from a patient’s own brain tumor is effective in slowing tumor progression and extending survival. The randomized phase 2 trial will study how well giving the study vaccine with or without Avastin (bevacizumab) works in treating patients with recurrent glioblastoma multiforme (GBM).
Bevacizumab
(Avastin, Genentech Inc.- Year approved:2009)
Avastin (or bevacizumab to the scientific community) is a humanised monoclonal antibody that is directed against all biologically active forms of VEGF. Antibodies are molecules that are typically a normal part of the human immune system. An antibody is meant to bind to a very specific target which is then typically destroyed and removed by the body. Avastin is an antibody that binds VEGF and acts to block its action.
Bevacizumab was one of the first antiangiogenic agents to demonstrate activity against metastatic kidney cancer. Bevacizumab is administered intravenously every two weeks. On July 31, 2009, the FDA granted approval for the use of Avastin in combination with interferon-? for the treatment of patients with metastatic renal cell carcinoma. The approval was based on results published in the journal Lancet in 2007. In this double-blind phase III trial 649 patients with metastatic kidney cancer who had undergone nephrectomy, were randomized to either bevacizumab plus Interferon-? or placebo plus Interferon-? as a first-line treatment. Median progression-free survival of patients was significantly improved in those receiving the combination treatment including Bevacizumab and Interferon-? compared to the control group (10.2 vs 5.4 months). Response rates were also significantly improved in the Bevacizumab and Interferon-? groups (31% vs 13%). The most common severe (grade 3) toxicity was fatigue: 12% in the bevacizumab and IFN arm versus 8% in the control arm.
A second multicenter phase III trial which was performed in 2008 and which was conducted in the United States and Canada, was nearly identical in design with the exception that it lacked a placebo element and did not require prior nephrectomy. In this second study, the average progression-free survival was 8.5 months in patients receiving The combination of Bevacizumab and Interferon-? compared to 5.2 months for patients receiving Interferon-? therapy alone. The overall response rate was in favour of the combination group (25.5% vs 13.1%). However, both studies failed to show any significant difference regarding overall survival between the combination of Bevacizumab and Interferon-? versus Interferon-? alone (18.3 vs 17.4 months).
Bevacizumab (trade name Avastin, Genentech/Roche) is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels. It is licensed to treat various cancers, including colorectal, lung, breast (outside the USA), glioblastoma (USA only), kidney and ovarian.
Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A). VEGF-A is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically availableangiogenesis inhibitor in the United States.
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certainmetastatic cancers. It received its first approval in 2004, for combination use with standardchemotherapy for metastatic colon cancer.It has since been approved for use in certain lung cancers, renal cancers, and glioblastoma multiforme of the brain.
At one point bevacizumab was approved for breast cancer by the FDA, but the approval was revoked on 18 November 2011. The approval for breast cancer was revoked because, although there was evidence that it slowed progression of metastatic breast cancer, there was no evidence that it extended life or improved quality of life, and it caused adverse effects including severe high blood pressure and hemorrhaging. In 2008, the FDA gave bevacizumab provisional approval for metastatic breast cancer, subject to further studies. The FDA’s advisory panel had recommended against approval. In July 2010, after new studies failed to show a significant benefit, the FDA’s advisory panel recommended against the indication for advanced breast cancer. Genentech requested a hearing, which was granted in June 2011. The FDA ruled to withdraw the breast cancer indication in November 2011. FDA approval is required for Genentech to market a drug for that indication. Doctors may sometimes prescribe it for that indication, although insurance companies are less likely to pay for it. The drug remains approved for breast cancer use in other countries including Australia.
Clinical trials are underway for many other indications including ovarian cancer, pediatric osteosarcoma, and certain non-malignant eye diseases. In the curative setting (adjuvant therapy), clinical studies are underway in breast cancer and lung cancer.
FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
Bevacizumab, CAS NO 216974-75-3
A MONOCLONAL ANTIBODY
January 23, 2013
Avastin (bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Avastin has an approximate molecular weight of 149 kD. Bevacizumab is produced in a mammalian cell (Chinese Hamster Ovary) expression system in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
On January 23, 2013, the FDA has approved a new use of Avastin® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC). The new indication will allow people who received Avastin plus an irinotecan or oxaliplatin containing chemotherapy as an initial treatment (first-line) for mCRC to continue to receive Avastin plus a different irinotecan or oxaliplatin containing chemotherapy after their cancer worsens (second-line treatment).
People who start on Avastin for mCRC can now stay on Avastin after their cancer worsens.
Bevacizumab (trade name Avastin, Genentech/Roche) is an angiogenesis inhibitor, a drug that slows the growth of new blood vessels. It is licensed to treat various cancers, including colorectal, lung, breast (outside the USA), glioblastoma (USA only), kidney and ovarian.
Bevacizumab is a humanized monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A).[1] VEGF-A is a chemical signal that stimulates angiogenesis in a variety of diseases, especially in cancer. Bevacizumab was the first clinically available angiogenesis inhibitor in the United States.[citation needed]
Bevacizumab was approved by the U.S. Food and Drug Administration (FDA) for certain metastatic cancers. It received its first approval in 2004, for combination use with standard chemotherapy for metastatic colon cancer.[2] It has since been approved for use in certain lung cancers, renal cancers, and glioblastoma multiforme of the brain.
At one point bevacizumab was approved for breast cancer by the FDA, but the approval was revoked on 18 November 2011.[3][4]
- Los, M.; Roodhart, J. M. L.; Voest, E. E. (2007). “Target Practice: Lessons from Phase III Trials with Bevacizumab and Vatalanib in the Treatment of Advanced Colorectal Cancer”. The Oncologist 12 (4): 443–50. doi:10.1634/theoncologist.12-4-443. PMID 17470687.
- http://www.gene.com/gene/products/information/pdf/avastin-prescribing.pdf
- Pollack, Andrew (18 November 2011). “F.D.A. Revokes Approval of Avastin for Breast Cancer”. New York Times.
- “Cancer drug Avastin loses US approval”. BBC. November 18, 2011.
SEQUENCE
>1bj1_H|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||VH-CH1 (VH(1-123)+CH1(124-215))|||||||231||||MW 24867.8|MW 24867.8| EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT >1bj1_L|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||L-KAPPA (V-KAPPA(1-107)+C-KAPPA(108-213))|||||||214||||MW 23451.0|MW 23451.0| DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >1bj1_J|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||L-KAPPA (V-KAPPA(1-107)+C-KAPPA(108-213))|||||||214||||MW 23451.0|MW 23451.0| DIQMTQSPSSLSASVGDRVTITCSASQDISNYLNWYQQKPGKAPKVLIYFTSSLHSGVPS RFSGSGSGTDFTLTISSLQPEDFATYYCQQYSTVPWTFGQGTKVEIKRTVAAPSVFIFPP SDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLT LSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC >1bj1_K|Fab-12, F(ab)-12, 12-IgG1, rhuMAb-VEGF|||VH-CH1 (VH(1-123)+CH1(124-215))|||||||231||||MW 24867.8|MW 24867.8| EVQLVESGGGLVQPGGSLRLSCAASGYTFTNYGMNWVRQAPGKGLEWVGWINTYTGEPTY AADFKRRFTFSLDTSKSTAYLQMNSLRAEDTAVYYCAKYPHYYGSSHWYFDVWGQGTLVT VSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVL QSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHT
