The cost effective, high quality alternative
Our quest for making high quality and affordable medicines for patients across the globe sparked our ambition of building a robust portfolio of biosimilars through our investments in biotechnology research. Biosimilars are biologic drugs that are ‘highly similar’ in chemical composition to costly name-brand drugs with similar therapeutic and clinical results. The global biosimilars market is fast evolving with biosimilars gaining good adoption in Europe and the U.S.
Our Biosimilar Capabilities
Lupin has three centres – Lupin Biotech, Lupin Research Park (LRP), and Lupin Bioresearch Center (LBC) – based in Pune, India the focus on biotech R&D and manufacturing.
Designed to develop and commercialise biosimilars globally and make new biological entities, Lupin Biotech conforms to ICH and biosimilar guidelines issued by the U.S. FDA, EMA, WHO, PMDA and the Indian regulatory bodies.
LRP has advanced capabilities for the development, manufacture and pre-clinical studies in both regulated and unregulated markets. The centre has two clinical labs and one bio-analytical lab supporting R&D.
LBC conducts both in-vivo and in-vitro bioequivalence studies as part of regulatory dossier submission for regulatory agencies across the globe. LBC has managed 74 studies in FY20 and cumulatively established over 300 validated analytical methods to date.
The biotech facility also includes a new 200 litre pilot-scale mammalian cell culture facility. The qualification for the facility has been completed which is expected to scale-up activities for early phase products. A rich portfolio of diverse biosimilars of both microbial and mammalian origin are in various stages of development. Cell line technology platforms are also being explored for the selection of high producer clones.
Top products launched
Lupin’s flagship project, Etanercept, has completed phase III of the global clinical trial and launched in Japan. The European Commission has granted marketing authorisation for Etanercept (branded Nepexto®) for all indications of the reference product, Enbrel® in June 2020.
Filgrastim and Peg-Filgrastim
Approval received for first IND in the U.S. for one of late-phase oncology products. A clinical study of the product is currently underway. Two oncology products — Lupifil® and Lupifil-P® (biosimilars for the molecules Filgrastim and Peg-Filgrastim respectively) have been launched in India. CTD filing and product registration is being lined up for entry into semi-regulated markets.
Lupin Biotech has signed agreements with the CSIR-National Chemical Laboratory, Pune, and the Department of Science and Technology, Delhi, to conduct research for the development of biosimilar mAbs. It has also partnered the Biotechnology Industry Research Assistance Council, a Section 8 enterprise set up by the Government of India’s Department of Biotechnology, for development of biosimilar products. The company has also entered into a joint venture with Yoshindo for development of Etanercept for EU and Japan. It has also partnered Myland and Nichi-iko for development of biosimilars.
- Clinical expertise – In-house team capable of managing multi-centric global clinical studies
- Strong R&D capabilities
- 6 biosimilars in active development
- Product development capabilities across microbial and mammalian platforms
- DS and DP manufacturing compliant to highest regulatory standards.
- Fast growing manufacturing base being set up to meet global commercialisation requirements
- Team strength
- Over ~400 member strong team
- Vial-to-vial biosimilar product expertise
- High-end characterisation capabilities in house
- Strong marketing and distribution network in domestic and international markets
- IP expertise
- Strong in-house team with good understanding of complex biosimilar IP landscape