Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylan‘s biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.
Bengaluru-based biopharmaceutical firm Biocon on Wednesday said the US drug regulator has accepted its partner Mylan’s biologics license application (BLA) for the proposed biosimilar of breast cancer drug trastuzumab through the 351(k) pathway.
This product is a proposed biosimilar version of Roche’s Herceptin, which is indicated to treat certain HER2-positive breast cancers.
"The anticipated FDA goal date set under the Biosimilar User Fee Act (BsUFA) is September 3, 2017," Biocon said in a statement.
A biosimilar is a complex biological product that follows a different approval pathway compared to chemical drugs.
If the drug gets USFDA approval, Biocon will become the first Indian drug maker to crack highly regulated US market for biosimilars.
Sandoz, the generic arm of Swiss pharma major Novartis and South Korea’s Celltrion were the only two companies that were able to get approvals through the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
The BPCI Act created an abbreviated licensure pathway for biological products shown to be "biosimilar” to or "interchangeable” with an FDA-licensed biological product, called the "reference product."
Biocon in partnership with Mylan NV, is developing four biosimilars—pegfilgrastim, trastuzumab, adalimumab and insulin glargine—for regulated markets such as Europe and US.
Biosimilars involve clinically testing the drug on animals and humans to demonstrate that the drug is highly similar to the innovator biological product (known as a reference product) and has no clinically meaningful differences in terms of safety and effectiveness from it.
"It is a major milestone for the Mylan and Biocon collaboration since it is the first US regulatory submission through our joint global biosimilars program," said Arun Chandavarkar, Chief Executive Officer and Joint Managing Director of Biocon.
"This development positions Biocon and Mylan among the first companies to be able to address the critical need of US patients for a high-quality biosimilar to treat certain HER2-positive breast cancers, in the near future," Chandravarkar said.
"We believe that our comprehensive package of analytical similarity, non-clinical and clinical data submitted with the BLA will demonstrate similarity of the proposed biosimilar trastuzumab to the reference product," said Mylan President Rajiv Malik.
Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by the European Medicines Agency (EMA).
Roche's subsidiary Genentech Inc. is the innovator of monoclonal antibody (those made by identical immune cells that are all clones of a unique parent cell) trastuzumab, which is used primarily in the treatment of HER 2 positive breast cancer. Herceptin had contributed $6.54 billion in global sales for Roche in 2015.
Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. HER2-positive metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20 percent to 30 percent of primary breast cancers are HER2-positive.
The announcement came after market hours.
Shares of Biocon rose 0.47 percent to close at Rs.1001.85 on BSE, the benchmark Sensex gained 0.90 percent to end 27,140.41 points.