USFDA accepts Biocon cancer drug biosimilar application

FDA decision likely in September; drug is similar to branded Trastuzumab, which treats breast cancer

India's largest biopharma firm Biocon Ltd and its US partner Mylan said the US Food and Drug Administration (USFDA) has accepted the biologics licence application for its biosimilar drug to treat breast cancers. An FDA would help the drug enter the lucrative US market.

The drug, a proposed biosimilar to branded trastuzumab, will be used to treat breast cancer. The companies expect a decision from FDA by September 3.

"This is Mylan and Biocon's first US regulatory submission through the 351(k) pathway and reinforces the strength of our collaboration to increase access to a broad portfolio of high-quality, affordable biosimilars worldwide," said Mylan President Rajiv Malik in a statement on Wednesday evening. "We are committed to bringing this product to market and look forward to working with FDA over the next months."

Biocon and Mylan had submitted the application to the FDA in November. In October, the European Medicines Agency had accepted an application from Biocon to market the insulin glargine it co-developed with Mylan NV, to treat type-2 diabetes and control high blood sugar for patients with type-1 diabetes.

"This development positions Biocon and Mylan among the first companies to be able to address the critical need of US patients for a high-quality biosimilar to treat certain HER2-positive breast cancers, in the near future," said Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon.

In July, Biocon tied up with Mexico's Laboratorios PiSA to jointly develop and sell a generic recombinant human insulin in the United States, a $2 billion market, one of the largest for insulin worldwide.

Biocon expects the insulin product by 2020 in the US, which accounts for nearly 40 per cent share of the global $5 billion insulin market.

Bengaluru-based Biocon, founded by Kiran Mazumdar Shaw, began selling its biosimilar insulin Glargine in disposable pens in July in Japan, the largest market for insulin outside of the US and Europe.

The ready-to-use prefilled disposable pen with insulin Glargine is manufactured at its unit by Biocon in Bengaluru and is being sold by its partner Fujifilm Pharma Co Ltd in Japan.

The Biocon stock closed 0.47 per cent of Rs 4.70 at Rs 1001.85 on the Bombay Stock Exchange on Wednesday. On Tuesday, the stock had risen to a 52-week high in intra-day trading to touch Rs 1,026, before closing at Rs 997.15