India's Biocon updates on biosimilar paths after strong Q1

By EJ Lane Jul 24, 2016 7:03pm

Bangalore-based Biocon is on track to file biosimilar approval applications for pegfilgrastim (Neulasta) in the U.S. and insulin glargine (Lantus), trastuzumab (Herceptin) and adalimumab (Humira) in the U.S. and European Union within the company's fiscal year.

That was the word from Managing Director Kiran Mazumdar-Shaw on the July 21 earnings call for the first quarter, which ended June 30.

The update and the state of play with sales and development partner Mylan ($MYL) in the space capped a strong quarter for the company. Biocon launched a Lantus biosimilar in Japan this summer and said last week that the European Medicines Agency will be reviewing an application for the marketing authorization of a biosimilar of pegfilgrastim.

"As a part of our global biosimilar foray, our partner Mylan filed the Marketing Authorization Application, or MAA, for biosimilar pegfilgrastim for the EU markets in Q1, which has been accepted by the EMA, European Medical Agency," Mazumdar-Shaw noted.

"The application will undergo the review process and this kicks off the process of filing of multiple biosimilar applications over the course of this fiscal (year)."

The company reported a 17% gain in net profit to INR1.47 billion ($22 million) and a revenue increase of 11% to INR9.5 billion ($141 million), with sales in of biologics up 53% on the emerging markets business.

An unidentified executive on the call said that in the case of trastuzumab, clinical results for the application are scheduled to be presented at the European Society of Medical Oncology Annual Congress, slated to be held in Copenhagen in October.

Roche ($RHBBY) and Biocon are involved in a legal dispute over a Herceptin biosimilar in India that hinges on the use of clinical data in the label that the Swiss-based firm says come from its work.

- here's the release from Biocon

Pre Approval Mylan Pharma Marketing Financials