FDA Committee Recommends Approval of Cancer Biosimilar

Biosimilar to trastuzumab (Herceptin) observed to have no clinically significant differences than the reference product.

Mylan recently announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended the approval of a biosimilar to the cancer drug trastuzumab (Herceptin).

ODAC unanimously recommended approval of the proposed biosimilar for indications matching the reference product, according to a press release.

Trastuzumab is indicated as an adjuvant therapy for HER2-positive breast cancer and is also indicated to treat metastatic breast and gastric cancers.

"We are pleased with ODAC's recommendation to support the approval of Mylan's proposed biosimilar trastuzumab to increase affordability, competition and most importantly overall access and use,” said Rajiv Malik, president at Mylan. “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."

The recommendation was based on positive data from analytical, nonclinical, and clinical studies that demonstrated that the proposed biosimilar was highly similar to the reference product. These findings were in line with the FDA assessment included in the pre-meeting briefing documents, according to Mylan.

ODAC found no clinically meaningful differences between the biosimilar and the reference product regarding safety, purity, and potency, which resulted in the approval recommendation. While the FDA typically follows the advice of the independent committees, they are not required to.

Mylan reported that the biosimilar is also being reviewed by regulatory authorities in Australia, Canada, Europe, and other countries.

Mylan partnered with Biocon to develop biosimilars and insulins. The proposed biosimilar to trastuzumab is 1 of 6 developed under the partnership, according to the release.

"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 Arun Chandavarkar, PhD, CEO and joint managing director at Biocon. “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."