US FDA approves Biocon's breast cancer biosimilar drug

Biocon's proposed biosimilar trastuzumab is under review by authorities in Australia, Canada, Europe

India's largest biopharma company Biocon said on Friday that the Oncologic Drugs Advisory Committee (ODAC) of the US Food and Drug Administration( FDA) has recommended the approval of Biocon's biosimilar trastuzumab - a drug used to treat breast cancer.

The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings, Biocon and its partner Mylan said in a joint statement.

Mylan President Rajiv Malik said the approval would help increase affordability, competition and overall access for the biosimilar in the US market.

"As one of the largest suppliers of cancer medicines by volume in the US, Mylan is committed to serving this important patient community. 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,” he said

Biocon CEO and Joint Managing Director Dr Arun Chandavarkar said the company was a step closer to addressing the critical needs of cancer patients in the US with the biosimilar.

"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,” he 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. ODAC determined that no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. As such, the committee concluded that the totality of evidence supports a recommendation for FDA approval.

FDA uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals. FDA 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 also is under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.