FDA panel approves Mylan-Biocon’s biosimilar cancer drug

Biopharmaceutical major Biocon and global pharmaceutical company Mylan NV on Thursday said the US FDA's Oncologic Drugs Advisory Committee (ODAC) has recommended approval of their proposed biosimilar cancer drug trastuzumab.

Trastuzumab is a biosimilar version of Roche's Herceptin, which is indicated for the treatment certain HER2-positive breast cancers in the metastatic and adjuvant settings.

If the breast cancer biosimilar drug gets USFDA's final nod, Biocon will become the first Indian drug maker to crack highly regulated US market for biosimilars.

In a joint announcement, Biocon Ltd and Mylan NV said the FDA 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, the two stated in a joint release.

''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. 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,'' Mylan president Rajiv Malik said.

''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. 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,'' Biocon CEO and joint managing director Dr Arun Chandavarkar said.

Based on analytical, clinical and nonclinical studies the FDA committee 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, the release said.

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.

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 commercialisation rights for the proposed biosimilar trastuzumab in the US, 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.