If the drug gets USFDA's nod, Biocon will become the first Indian drug maker to crack highly regulated US market for biosimilars.
Biopharmaceutical company Biocon has said the US FDA's Oncologic Drugs Advisory Committee (ODAC) has recommended approval of its proposed biosimilar trastuzumab.
The committee voted 16-0 in support of eligible indications of the reference product.
If the breast cancer biosimilar drug gets USFDA's nod, Biocon will become the first Indian drug maker to crack highly regulated US market for biosimilars.
Trastuzumab is a proposed biosimilar version of Roche’s Herceptin, which is indicated to treat certain HER2-positive breast cancers in the metastatic and adjuvant settings.
"ODAC determined that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency," a joint statement by Biocon and Mylan said.
"As such, the committee concluded that the totality of evidence supports a recommendation for FDA approval," the statement added.
US FDA uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals.
The agency often follows the advice of ODAC in determining whether a product should come to market, although they are not required to follow it.
Mylan and Biocon's proposed biosimilar trastuzumab along with US FDA is also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.
Biocon has teamed up with Mylan to develop and commercialise the drug.
The vote marked the first proposed biosimilar trastuzumab to be recommended by the committee.
“We welcome ODAC’s endorsement of our biosimilar trastuzumab as it brings our collaboration a step closer to addressing the critical needs of cancer patients in the US," said Biocon CEO and Joint Managing Director Arun Chandavarkar.
"We now look forward to engaging with the FDA to seek final approval in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers,” Chandavarkar said.
"We look forward to working with FDA to further increase access to this important treatment option for the thousands of patients affected by HER2-positive breast cancer each year,” Mylan President Rajiv Malik said.
Data presented to ODAC included results from analytical, nonclinical and clinical studies which demonstrated that our proposed biosimilar trastuzumab is highly similar to Herceptin, in line with the FDA assessment provided in the pre-meeting briefing documents.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products.
The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar trastuzumab in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.
A biosimilar is a complex biological product that follows a different approval pathway compared to chemical drugs. They 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.
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.
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).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.