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Equity | News | Hot Pursuit
Hot Pursuit
Biocon buoyant after US biosimilar launch
(09:19, 03 Dec 2019)

The announcement in an exchange filing was made after market hours yesterday, 2 December 2019.

Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin and is used in the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer junction.

The company further added that the USFDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and has no meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency.

Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon's first U.S. biosimilar, Fulphila, a biosimilar to Neulasta. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the U.S. and global markets for both products.

Earlier in October, the USFDA had also approved Biocon's new Drug Product (DP) filling line for biosimilar Trastuzumab 150 mg vials at the Biologics facility in Bengaluru, following a pre-approval Inspection (PAI) of the facility in September 2019.

Biocon has surged 31.02% in three months as compared to a 1.93% rise in Nifty Pharma index. The stock trades above its 50-day and 200-day moving average (DMA) placed at Rs 248.97 and Rs 265.57 respectively.

Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It is a leading global player for high quality biosimilars, APIs including statins, immunosuppressants and specialty molecules.

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