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Biocon's biosmilar chase gets a boost with EU approval for Ogivri

PB Jayakumar     December 19, 2018

Drug major Biocon's plans of tapping the biosimilar or -- reverse engineered new versions of biotech origin drugs -- got a fillip following the European Commission's approval and marketing authorisation to its biosimilar Ogivri.

Ogivri (Trastuzumab), jointly developed by Biocon and Mylan, is the biosimilar version of Swiss drug maker Roche's Herceptin, a blockbuster breast cancer drug with sales of $6.9 billion a year worldwide. The drug is also indicated for gastric cancer treatment. Roche's leading product, Herceptin has over $2 billion sales in the European Union. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had previously issued a positive opinion recommending approval of Ogivri as a biosimilar in October.

The approval for Ogivri is the third biosimilar approval for Biocon in the EU. It had earlier got approvals for Pegfilgrastim and insulin glargine. Biocon is developing about 11 biologic and insulin products. In most of these products, while Biocon will develop the product, Mylan will handle its marketing in major markets and regulatory processes. Biocon also has a strategic partnership with Sandoz for developing next generation immunology and oncology biosimilars.

Ogivri had got approval from the US Food and Drug Administration (USFDA) in December 2017 as the first USFDA-approved biosimilar for Herceptin in the US. The drug is yet to be launched in the US. A couple of days ago, the US FDA had approved South Korean drug maker Celltrion and Israel generic major Teva's Herceptin biosimilar Herzuma. Companies like Pfizer Samsung and Amgen have also developed biosimilars for Herceptin and a few more companies are chasing development of the same biosimilar.

Biocon had earlier given a guidance of $200 million revenue in FY19 from its biosimilar portfolio.  The company had total revenues of Rs 4,336 crore in 2017-18. In the first half of FY19, biocon got Rs 617 crore revenues from its biologics business, a growth of 82 per cent. Last year revenues for Biocon from biologics were Rs 770 crore.

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