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 THIS YEAR
The successful completion of the Phase III Global Clinical Trial of Lupin’s flagship project Etanercept was a remarkable feat. The Common Technical Document (CTD) and Application for Marketing Authorization were filed with the Japanese regulatory authority (PMDA), by Lupin’s subsidiary in Japan, Kyowa Pharmaceutical. While commercialization strategies for Japan and EU will be pursued through partnerships, strategies are currently being developed for conducting US-centric studies with this product based on the complex regulatory, IP and competitive landscape. The upcoming year will entail exciting milestones for this project, with MAA filings lined up in Europe, Australia and Canada and accomplishing these would pave the path for future regulatory audits wherein Lupin Biotech will be able to showcase its capabilities to the most stringent regulators.
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 was designed based on US FDA’s scientific advice and a clinical study of the product has been initiated.
In FY2018, the Biotech division filed a total of 3 new patents in India and 3 PCT applications. In addition, 4 patent grants were secured, 1 in the US and 3 in South Africa. Pursuant to past patent filings, 15 applications entered the national phase in various territories.
Construction and qualification of a 200 L pilot scale mammalian cell culture facility is nearing completion and expected to boost scale-up activities for early phase products.
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 was successfully completed for two of the early phase projects in the last financial year.
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.
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.