The Mumbai-based drug firm has entered into a license, supply and technology sharing agreement with Axantia Holding, a leading pharmaceutical company in the Middle East region, Lupin said in a statement.
Biocon Ltd. and Mylan N V on Tuesday announced the launch of Fulphila, a biosimilar to Neulasta (pegfilgrastim), in Australia.
Biotech company, Biocon will see two crucial inspections later this month and in early April. Company‘s manufacturing sites will come up for inspections by the European medicines agency later this month and next will be an inspection by the US FDA.
Biocon shares gained 2.6 percent to hit a record high of Rs 1,123 after the US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim.
Biocon Thursday announced the US Food and Drug Administration has accepted Mylan‘s Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Sharing details on the development with CNBC-TV18 Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said, "This is a very important acceptance."
Biocon is among the companies that gave a good performance in 2016 and the stock surged 80 percent this year. Speaking to CNBC-TV18, Kiran Mazumdar Shaw, CMD of the company, said the company has gained traction in many emerging markets with its biosimilars.
The European Medicines Agency (EMA) has accepted to review Mylan and Biocon‘s application for a biosimilar called Trastuzumab, used for certain breast and gastric cancers.
These market filings have a market opportunity of USD 40 billion. In particular, Japan offers a market potential of USD 150 million for its insulin product Glargine, says Biocon's Chairman and Managing Director.
It believes that Biocon's (and its partner Mylan) four potential product filings each in the US and EU would add credibility to its pipeline and bring market recognition. Emerging market monetisation is under way, but the US and EU opportunities will take at least two years, according to report.