Biocon announced that Siddharth Mittal has taken over as Chief Executive Officer & Joint Managing Director of the Company starting 01 December 2019. Mittal has been serving as Biocon's Chief Financial Officer (CFO) since August 2014.

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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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Biocon and Mylan announced the U.S. launch of Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility.

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 including for the treatment of HER2-overexpressingbreast cancer and metastatic stomach cancer (gastric or gastroesophageal junctionadenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning forcardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.

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 fulfildemand in the U.S. and global markets for both products.

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The stock has risen 10.6% in five trading sessions from its closing low of Rs 254.20 on 21 November 2019. The stock advanced 22.83% in last three months as compared to a 6.57% rise in Nifty Pharma index in the same period.

The pharmaceutical company jumped 4.63% yesterday after the US drug regulator approved the company's supplemental biologics license application for Pegfilgrastim new manufacturing facility.

Earlier this month, the stock received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its Biologics drug product facility in Bengaluru. The USFDA in October 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.

On the technical front, the stock's RSI (relative strength index) stood at 69.892. The RSI oscillates between zero and 100. Traditionally the RSI is considered overbought when above 70 and oversold when below 30.

The stock trades above its 50-day and 200-day moving average (DMA) placed at Rs 246.76 and Rs 266.02 respectively.

Biocon is a bio pharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It is a leading global player for APIs including statins, immunosuppressants and specialty molecules.

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