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BIOTECHNOLOGY

Based out of Pune, Lupin Biotech, our world-class R&D centre was founded in 2008 with advanced capabilities in areas like development, manufacturing and pre-clinical studies to clinical programs in biotechnology products required for approval in both regulated and semi-regulated markets.

The developmental pipeline includes a mix of blockbuster products of both microbial and mammalian origin, across diverse indications such as rheumatoid arthritis, ophthalmology, oncology and osteoporosis indications.

Highlights for FY 2017

  • Construction and commissioning of state-of-the-art fill-finish facility within the Biotech premises
  • The first two oncology products commercialized in India: Lupifil® and Lupifil-P® (biosimilars for the molecules- Filgrastim and Peg-Filgrastim) are steadily gaining tractionin the Indian market since its launch in May 2015. Preparations are underway to seek approval and register these products across global markets
  • Biosimilar for Etanercept (brand Enbrel) is being developed currently with YL Biologics (the joint venture of Lupin and Yoshindo, Japan) and the global Phase-III clinical trials are nearing completion. Our global trials for biosimilar Etanercept were conducted across Japan, India and markets of Europe on over 500 patients

The coming year has exciting milestones to look forward to, especially with MAA filings slated in Japan and Europe. The manufacturing facility is also gearing up for audits by respective regulatory agencies and paving a path for swift commercialization of the product.

Comprehensive regulatory strategies are being devised to optimize the development timelines. Clinical trial initiation for two more priority projects are planned in the upcoming year, in addition to the ongoing trials for Etanercept.

The pipeline is well positioned to ride the wave of upcoming biosimilars in the short and long term respectively. High throughput methods, automation and future technologies are being put to test for the development and selection of high-yielding Biosimilar clones.

The Company’s efforts during the year resulted in its filing 3 National Phase patents in the global markets accompanied by 2 provisional patents and 1 PCT application.

Lupin Biotech plans to progress across markets with international partners possessing complementary capabilities in product development, IP generation and commercialization. This would help to mitigate risk and achieve higher execution success. The Company hopes to realize our ambition of positioning Lupin Biotech as a global player navigating complex regulatory, IP and socio-economic framework.