Lupin Biotech was set up in 2008 with a vision to produce high-quality biologics more affordable and accessible to the patients globally. Lupin’s Biotechnology Development Program is based out of Pune in India.
The state-of-the-art Research facility was founded in 2008 with advanced capabilities like development, manufacturing and pre-clinical studies to clinical programs in biotech products required for approval in both regulated as well as semi-regulated markets. The cGMP facilities for microbial as well as mammalian cultures was commissioned in 2010.
The Lupin Biotech Group has a talent pool of close to 300 people comprising of approximately 11% PhDs and 63% post graduates.
What differentiates Lupin from the rest is that we have persevered to do the same things differently. Product Development to meet Global standards has been the key driver for Team Lupin. We focus on Good Regulatory Practices along with focusing on Good Manufacturing Practices, which helps us navigate through an ever-changing regulatory and IP landscape and adapt to the dynamic business needs.
We conform to ICH and biosimilar guidelines issued by US FDA, EMA, WHO, PMDA and the Indian regulatory bodies during the entire development and commercial cycle of our product. Our Manufacturing and the Regulatory teams work in tandem with our Clinical teams who have the expertise to carry out global multi-centric clinical trials.
The holistic effort of all our teams has positioned Lupin strongly in the rather crowded global biosimilars arena. In this highly competitive business, winners will be determined by their long-term commitment to quality, cost effectiveness and steady meandering through rapidly evolving global regulatory and commercial landscape.
At Lupin, we pride ourselves in being at the vanguard of the relentless pursuit towards becoming a global biosimilar player.
Lupin’s Biotech facility is spread over 22,000 square meters at Pune, India. It houses a pipeline of 10 biosimilars in various stages of development.
In 2015, the first two Oncology products were commercialized in India – Lupifil and Lupifil-P (biosimilars for molecules Filgrastim and Peg-Filgrastim).
Biosimilar for Etanercept (brand Enbrel®) is being developed for Global markets. A Global Phase-III clinical trial has been conducted across Japan, India and Europe on over 500 patients. Etanercept has been filed for an NDA (New Drug Application) in Japan and a Marketing Authorisation Application in Europe.
Further, the developmental pipeline at Lupin includes a mix of blockbuster products of both microbial and mammalian origin across diverse indications such as Rheumatoid Arthritis, Oncology, Ophthalmology and Osteoporosis targeting a total global market of over USD 30bn.
GLOBAL BIOSIMILAR PIPELINE
Lupin Limited (Biotech Division),
Gat No 1156, Village Ghotawade, Taluka Mulshi, Pune 412115. India
Lupin Limited (Biotech Division),
1st and 4th Floor, G.O Square,
Sr. No. 249 / 50, Near Mankar Chowk,
Wakad, Pune 411057, India
89 Headquarters Plaza,
North / Suite 1428 / Morristown,
LUPIN BIORESEARCH CENTRE
The Lupin Bioresearch Centre (LBC) located in Pune, India, has continuously maintained its outstanding performance on the regulatory compliance front with successful UK MHRA, US FDA, DCGI and NABL inspections in FY 2017 for conducting bioequivalence studies for Lupin’s generic products and branded formulations.