Biocon Ltd, a leading biotech firm has now received a regulatory approval to market a drug jointly developed with US-based pharma company Mylan that may help treat breast cancer.
"We have received market authorisation from the Drugs Controller General of India (DCGI) for our biosimilar Trastuzumab developed with Mylan for the treatment of metastatic breast cancer," the city-based company said in a statement Tuesday.
Angiogenesis And Cancer Growth Controllable By Methylation Signaling
A new mechanism that involves a signalling protein and its receptor could now block the spread of cancer and formation of new blood vessels, according to a new study
Advertisement
The approval makes the drug the world's first biosimilar version of Herceptin to be marketed in the country under its brand Canmab for breast cancer patients in the next four months.
"The approval is a milestone for both partners as it is the world's first biosimilar Trastuzumab to be marketed. We plan to make the drug available for Indian patients in the fourth quarter of this fiscal (2013-14)," Biocon chairperson Kiran Mazumdar Shaw said in the statement.
![Over-Regulation of Pain Medicines Leading to Pandemic of Untreated Cancer Pain]( "Over-Regulation of Pain Medicines Leading to Pandemic of Untreated Cancer Pain")
Over half of the world's population live in countries where regulations that aim to stem drug misuse leave cancer patients without access to opioid medicines.
Breast cancer is one of the most common types of cancer in India, with over 100,000 new patients being diagnosed with this disease every year. The cost of biologics in cancer treatment is high, which makes access unaffordable to a large patient pool.
"Biosimilar Trastuzumab will offer an alternative affordable option thereby enhancing access to treatment for cancer patients in India and the world over," Shaw said.
The development of the drug involved product characterisation and clinical trains to demonstrate comparability and similarity in pharmacokinetic, safety, efficacy and immunogenicity.
Sales of the drug the world over posted $6.4 billion in 2012 and $21 million in India.
Both the partners have been co-developing the biosimilar monoclonal antibodies and complex biologics since 2009.
Source: IANS
Over-Regulation of Pain Medicines Leading to Pandemic of Untreated Cancer Pain
Over half of the world's population live in countries where regulations that aim to stem drug misuse leave cancer patients without access to opioid medicines.
Advertisement
Breast cancer is one of the most common types of cancer in India, with over 100,000 new patients being diagnosed with this disease every year. The cost of biologics in cancer treatment is high, which makes access unaffordable to a large patient pool.
"Biosimilar Trastuzumab will offer an alternative affordable option thereby enhancing access to treatment for cancer patients in India and the world over," Shaw said.
The development of the drug involved product characterisation and clinical trains to demonstrate comparability and similarity in pharmacokinetic, safety, efficacy and immunogenicity.
Sales of the drug the world over posted $6.4 billion in 2012 and $21 million in India.
Both the partners have been co-developing the biosimilar monoclonal antibodies and complex biologics since 2009.
Source: IANS
High Cholesterol Fuels Breast Cancer Growth
Scientists have discovered the association between high cholesterol and breast cancer, especially in post-menopausal women. Published in the Nov. 29, 2013, edition of the journal Science .
Advertisement
Advertisement
|
Advertisement
Recommended Readings
Latest Cancer News
The new study uncovers the efficacy of fixed-duration combination treatment in patients with high-risk leukemia.
The approvals of pipeline drugs such as momelotinib and Vonjo for myelofibrosis (a rare type of blood cancer) over some time will handle the critical unmet needs.
New study highlights the dual role that blood vessels can play in cancer immunotherapy and eliciting anti-tumor immune responses or even preventing breast cancer spread.
New study evaluated the association between exposure to the chemical agent orange and the development of blood cancer with increased bleeding and blood clot formation.
Study suggests two-year immunotherapy treatment for advanced lung cancer may be reasonable