FDA panel backs approval of Mylan, Biocon's proposed Herceptin biosimilar

Mylan and Biocon said that an FDA advisory committee voted 16-0 recommending approval of the company's proposed biosimilar version of Roche's breast cancer therapy Herceptin (trastuzumab). Mylan and Biocon noted that the panel backed clearance of the drug in all eligible indications of the reference product, which include HER2-positive breast cancer in the metastatic and adjuvant settings, adding that the vote marks the first proposed Herceptin biosimilar to be recommended by the committee.

According to Mylan and Biocon, data presented to the Oncologic Drugs Advisory Committee included results from analytical, non-clinical and clinical studies, which demonstrated that the proposed biosimilar product, dubbed MYL-1401O, is "highly similar" to Herceptin. The panel also determined that "no clinically meaningful differences exist" between the biosimilar product and Herceptin in terms of safety, purity and potency.

Mylan and Biocon's proposed biosimilar version of Herceptin is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets. Under the companies' deal, which covers a portfolio of biosimilar and insulin products, Mylan has exclusive commercialisation rights for the proposed Herceptin biosimilar in the US, Canada, Japan, Australia, New Zealand and in the EU. Meanwhile, Biocon has co-exclusive marketing rights with Mylan for the product in the rest of the world.

For further analysis on the adoption of biosimilar cancer treatments, see Biosimilars in Oncology: KOL Insight.

Analysts at Edelweiss Securities said the news was "a big positive for Biocon," noting that the "only obstacle to approval is resolution of observations at Bangalore plant which [the] company is confident to resolve." In May, Biocon indicated that it has responded to all observations identified by the FDA during a recent inspection of its Bengaluru facility. The agency had previously made eight observations relating to deviations from good manufacturing practices at the Bengaluru plant after a site inspection earlier this year.

"The company has already settled with innovator for launch in mid-2019," Edelweiss Securities analysts noted, adding the "key thing to watch is how many more players come up before mid-2019. Five players are in the queue." In March, Mylan announced that it agreed to the terms of a settlement with Roche regarding patents for Herceptin, giving the company a "clear pathway" to commercialise its version of the product in various global markets.

For related analysis, read FirstWord Lists: Roche's near-term biosimilar threat in Europe.

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