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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 manufacturing was commissioned in 2010.

The Lupin Biotech Group has a talent pool of close to 400 people comprising of approximately 11% PhDs and 63% post graduates.

OUR EXPERTISE

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.

RESEARCH AND PIPELINE

Despite being a late entrant into the biosimilars space, Lupin has made significant progress towards the development of biosimilar products with a primary focus on regulated markets. Product development to meet the highest regulatory standards has been a key focus at Lupin, leading to the establishment of strong capabilities across the value chain.

Additionally, comprehensive regulatory and clinical strategies are developed, based on early advice from US FDA, EMA, Health Canada, TGA, PMDA and others to harmonize regulatory expectations across geographies and establish a totality of evidence.

KEY HIGHLIGHTS

The successful completion of the Phase III Global Clinical Trial of Lupin’s flagship project Etanercept was a remarkable feat. The product is approved and commercial in Japan and commercialization in EU is expected in 2020.. Further, for Etanercept strategies are currently being developed for conducting US-centric studies with this product based on the complex regulatory, IP and competitive landscape. With GMP certificates from PMDA and EMA already in place for the manufacturing facilities, e upcoming year will entail exciting milestones for this project, with MAA filings lined up in Europe, Australia and Canada and commercialization plans kicking in, Lupin Biotech will be able to showcase its capabilities.

Another notable development is the submission and approval of Lupin Biotech’s first IND in the US for one of its late phase oncology products. The US-centric clinical strategy has been designed based on US FDA’s scientific advice and a clinical study of the product is ongoing.

Construction and qualification of a 200 L pilot scale mammalian cell culture facility is completed and expected to boost scale-up activities for early phase products. Further large-scale expansion is ongoing at the Pune site to support the commercialization plan for the Biotech products and expected to be operational by 2022.

Lupin continues to enjoy a good market share in India for its first two oncology products, Lupifil® and Lupifil-P® (Biosimilars for the molecules Filgrastim and Peg-Filgrastim respectively). In parallel, CTD filing and registration of the products are being lined up for entry into semi-regulated markets. The enrichment of our early-stage pipeline is a key focus area, with a clear focus on faster development timelines and proven bio-similarity of the product. Alongside, cell line technology platforms are continually explored in-house for selection of high producer clones. Clone development and the selection has been successfully completed for the early phase projects.

Lupin has taken a major initiative towards the establishment of industry-academia collaboration. An agreement has been signed with CSIR-National Chemical Laboratory (CSIR-NCL, Pune) and Department of Science and Technology, (DST) Delhi for conducting research on continuous purification technology for the development of biosimilar mAbs. Collaboration with BIRAC is also one of the key industry – government initiative that the Biotech team has also undertaken.

We continually strive to become the partner of choice by adopting a quality framework in line with global norms, reinventing business models and adapting quickly to the changing needs of the biosimilar landscape.

Lupin’s Biotech facility is spread over ~10 acres at Pune, India. It houses a pipeline of 6 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®) has been developed for Global markets. A Global Phase-III clinical trial has been conducted across Japan, India and Europe on over 500 patients. Etanercept in approved and launched in Japan and a Marketing Authorisation Application in Europe is expected shortly with commercialization being expected this year.

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.

CONTACT US

PUNE

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.